Comparative evaluation of efficacy of Trayodashang Guggul versus Rasona Pinda as an adjuvant with Katibasti in the management of Grudhrasi (Sciatica):  A randomized controlled trial

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In this mainly bodily humours vata and kapha are vitiating producing symptoms like piercing pain, stiffness, twitching, numbness and pain radiating from lumbosacral region to lower limb up to the foot. Therapeutic plan includes stabilizing and bringing back the vitiated vata and kapha humours to equilibrium. The prevalence of sciatica varies considerably ranging from 3.8% in the working population to 7.9% in the nonworking population. Aim Comparative evaluation of efficacy of Rasonapinda and Trayodashang guggul as an adjuvant to katibasti (oil pooling therapy) in the management of Grudhrasi (Sciatica). Objectives To assess the efficacy of Rasonapinda as an adjuvant to katibasti in subjective and objective parameters of Grudhrasi (Sciatica). To assess the efficacy of Trayodashang guggul as an adjuvant to katibasti in subjective and objective parameters of Grudhrasi (Sciatica). To compare the efficacy of Rasonapinda and Trayodashang guggul as an adjuvant to katibasti in subjective and objective parameters. Standardisation of Rasonapinda (modified formvati). Methods In this study, a total of 60 patients will be enrolled and divided equally into two groups. In group A, Trayodashang Guggul 500 mg twice a day after meal with warm water for 30 days adjuvant with katibasti for the initial 7 days will be given. In group B, Rasonapinda 500 mg twice a day after meal with warm water adjuvant with katibasti for the initial 7 days will be given for 30 days. Result The result will be assessed on baseline of subjective and objective parameters and data will be compared after treatment. Conclusions It will be based on observations and results obtained. Trial registration CTRI No. - CTRI/2022/12/048534 Dated – 27/12/2022. 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F1000Research 2024, 13 :9 ( https://doi.org/10.12688/f1000research.139568.3 ) NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article. Close Copy Citation Details Export Export Citation Sciwheel EndNote Ref. Manager Bibtex ProCite Sente EXPORT Select a format first Track Share ▬ ✚ Study Protocol Revised Comparative evaluation of efficacy of Trayodashang Guggul versus Rasona Pinda as an adjuvant with Katibasti in the management of Grudhrasi (Sciatica): A randomized controlled trial [version 3; peer review: 1 approved, 2 approved with reservations] Mayank Rai https://orcid.org/0000-0002-2519-5620 1 , Sadhana Misar https://orcid.org/0000-0003-0165-0171 1 , Reeya Gamne https://orcid.org/0000-0002-8960-2977 1 Mayank Rai https://orcid.org/0000-0002-2519-5620 1 , Sadhana Misar https://orcid.org/0000-0003-0165-0171 1 , Reeya Gamne https://orcid.org/0000-0002-8960-2977 1 PUBLISHED 12 Aug 2024 Author details Author details 1 Datta Meghe Institute of Higher Education & Research, Wardha, Maharashtra, India Mayank Rai Roles: Conceptualization, Data Curation, Formal Analysis, Investigation, Methodology, Resources, Software, Validation, Visualization, Writing – Original Draft Preparation Sadhana Misar Roles: Methodology, Software, Supervision, Validation, Visualization, Writing – Review & Editing Reeya Gamne Roles: Resources OPEN PEER REVIEW DETAILS REVIEWER STATUS This article is included in the Datta Meghe Institute of Higher Education and Research collection. Abstract Background In ayurveda, sciatica can be correlated to ‘ Grudhrasi’ under Vata Nanatmaja-Vyadhi (neurological disorders caused by Vata , one of the bodily humour). In this mainly bodily humours vata and kapha are vitiating producing symptoms like piercing pain, stiffness, twitching, numbness and pain radiating from lumbosacral region to lower limb up to the foot. Therapeutic plan includes stabilizing and bringing back the vitiated vata and kapha humours to equilibrium. The prevalence of sciatica varies considerably ranging from 3.8% in the working population to 7.9% in the nonworking population. Aim Comparative evaluation of efficacy of Rasonapinda and Trayodashang guggul as an adjuvant to katibasti (oil pooling therapy) in the management of Grudhrasi (Sciatica). Objectives To assess the efficacy of Rasonapinda as an adjuvant to katibasti in subjective and objective parameters of Grudhrasi (Sciatica). To assess the efficacy of Trayodashang guggul as an adjuvant to katibasti in subjective and objective parameters of Grudhrasi (Sciatica). To compare the efficacy of Rasonapinda and Trayodashang guggul as an adjuvant to katibasti in subjective and objective parameters. Standardisation of Rasonapinda (modified formvati). Methods In this study, a total of 60 patients will be enrolled and divided equally into two groups. In group A, Trayodashang Guggul 500 mg twice a day after meal with warm water for 30 days adjuvant with katibasti for the initial 7 days will be given. In group B, Rasonapinda 500 mg twice a day after meal with warm water adjuvant with katibasti for the initial 7 days will be given for 30 days. Result The result will be assessed on baseline of subjective and objective parameters and data will be compared after treatment. Conclusions It will be based on observations and results obtained. Trial registration CTRI No. - CTRI/2022/12/048534 Dated – 27/12/2022. READ ALL READ LESS Keywords Grudhrasi,Sciatica,katipradesh,Ruka,Rasonapinda,trayodashang guggul,katibasti,dashmool taila. Corresponding Author(s) Mayank Rai ( [email protected] ) Close Corresponding author: Mayank Rai Competing interests: No competing interests were disclosed. Grant information: The author(s) declared that no grants were involved in supporting this work. Copyright: © 2024 Rai M et al . This is an open access article distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. How to cite: Rai M, Misar S and Gamne R. Comparative evaluation of efficacy of Trayodashang Guggul versus Rasona Pinda as an adjuvant with Katibasti in the management of Grudhrasi (Sciatica): A randomized controlled trial [version 3; peer review: 1 approved, 2 approved with reservations] . F1000Research 2024, 13 :9 ( https://doi.org/10.12688/f1000research.139568.3 ) First published: 03 Jan 2024, 13 :9 ( https://doi.org/10.12688/f1000research.139568.1 ) Latest published: 12 Aug 2024, 13 :9 ( https://doi.org/10.12688/f1000research.139568.3 ) Revised Amendments from Version 2 Changed the study setting and mentioned controlled group & interventional group as suggested by the reviewer and made necessary corrections as suggested. Changed the study setting and mentioned controlled group & interventional group as suggested by the reviewer and made necessary corrections as suggested. See the authors' detailed response to the review by Vaibhav Bapat See the authors' detailed response to the review by Shrilatha Kamath READ REVIEWER RESPONSES Introduction Grudhrasi is a pain dominant ( Vata Nanatmaja Vyadhi ) neurological disorder. It is identified by pain in the lower back region which radiates downwards to the lumbar, lower back , thigh , popliteal area , calf region , and foot. 1 Acharya Charak has described two types of Grudhrasi Vata dominant and Vata-Kapha dominant. The Vata dominant type of Grudhrasi is characterized by pain starting from buttock and then radiates to the lumbar , lower back, thigh, popliteal area, calf, and foot along with stiffness, pain, pricking sensation, and twitching. Whereas in Vata-Kapha dominant type of Grudhrasi , aversion to food, drowsiness, and feeling of heaviness are found, which causes the restricted movement of lifting of the leg. 2 In modern science grudhrasi can be correlated with Sciatica due to similarity in symptoms like severe radiating pain that spreads down one or both legs along the sciatic nerve that originates in the lower back. Sciatica is a crippling condition in which the patient feels pain and/or paraesthesias in the sciatic nerve’s or a related lumbo sacral nerve root’s distribution. 3 The disorder has a significant socio economic impact and has the potential to become chronic and irreversible. 4 Iin India, 2-40 percent of individuals suffer from sciatica. This occurrence is age-related and unlikely before the age of 20. According to reports, 1 to 10% of the population can suffer sciatica, with individuals aged 25 to 45 being the most commonly affected. 5 In modern management of sciatica, mostly non-steroidal anti inflammatory drugs (NSAIDSre used and symptomatic treatment is done. Ayurveda has many more effective methods for treating this excruciating condition. In this disease, mainly Apana and Vyana Vayu (types of vata humour in body) vitiation are observed, but most of the times Kapha humour remain associated in pathogenesis of disease. Therefore, the recommended medicine for treating Grudhrasi should be vata pacifying , kapha pacifying , and one which normalizes vata movement in body. 6 Besides this, medicine should be digestive-carminative, and pain alleviating in properties. In Bhaishajya Ratnavali (one of the classics if ayurveda), Rasonapinda is mentioned in the management of Grudhrasi having Rasona ( Allium sativum ) as a chief ingredient. 7 In phytochemical study, the presence of alkaloids in Allium sativum extract shows the potential to have an analgesic, anti-inflammatory, antioxidant and adaptogenic effect. In addition, Katibasti (oil pooling therapy) is a successful method for rejuvenation of body tissues that involves applying and retaining specially prepared heated herbal oil inside a border made of flour that is kept in the lower back for a predetermined amount of time. 8 It lubricates the joints, strengthens the muscles and connective tissue, and increases flexibility. Modern therapy includes the use of analgesics, epidural steroid injections and surgery. It has limitations due to side effects and is expensive. In Ayurveda Oleation , sudation (steam therapy) , blood letting , therapeutic heat burn (Agnikarma) , enema therapy and palliative therapies are indicated. Palliative therapies are non invasive, simple, safe and cost effective. In classics, various formulations are mentioned for non-invasive therapy like trayodashang guggul, vatari guggul etc. 9 In Bhaishajya Ratnavali, Rasonapinda has been mentioned in the management of Grudhrasi. Though vata and kapha are the bodily humour vitiated in Grudhrasi , the impact of digestive fire is not ignored in the pathogenesis of Grudhrasi. Rasonapinda is totally herbal in nature having analgesic, anti-inflammatory, digestive, carminative properties which will help in correcting weak digestive fire and reducing symptoms like pain, and stiffness. 10 Consequently, this research is being done to assess the efficacy of Rasonapinda in the management of Grudhrasi (sciatica). Aim Comparative evaluation of efficacy of Rasonapinda and Trayodashang guggul as an adjuvant to katibasti (oil pooling therapy) in the management of Grudhrasi (sciatica). Objectives 1) To assess the efficacy of Rasonapinda as an adjuvant to katibasti in subjective and objective parameters of Grudhrasi (sciatica). 2) To assess the efficacy of Trayodashang guggul as an adjuvant to katibasti in subjective and objective parameters of Grudhrasi (sciatica). 3) To compare the efficacy of Rasonapinda and Trayodashang guggul as an adjuvant to katibasti in subjective and objective parameters. 4) Standardisation of Rasonapinda (modified form-vati). Methods Study setting The patients will be selected from OPD and IPD of department of kayachikitsa of the Mahatma Gandhi Ayurved College, Hospital & Research Centre, Salod (H) and peripheral camps, mainly the population of Wardha district including patients of all community, (Maharashtra) India. A total of 60 patients will be recruited for the study. They will randomly be divided into two groups; Group A (controlled group) – Trayodashang Guggul , and Group B (interventional group) – Rasona Pinda . All the baseline parameters will be recorded at the start of the study. The patients will undergo treatment for 30 days for both groups. All the parameters will be recorded at the 0 th , 15 th , 30 th , 45 th day of the study duration. Sample size: 60 (including sample size calculation). Grouping: Group A (controlled group) – (n=30) Trayodashang Guggul as an adjuvant to katibasti (oil pooling therapy). Group B (Interventional group) – (n=30) Rasonapinda as an adjuvant to katibasti (oil pooling therapy). All the baseline parameters will be recorded at the beginning of the study. The patients will undergo treatment for 30 days in both groups. Follow ups will be taken on the 15 th and 30 th days during treatment and the 45 th day after treatment. Guidelines: The SPIRIT guidelines were used for the study protocol. 11 Case definition: Patients between 20–60 years of either sex having classical signs and symptoms of Grudhrasi (sciatica) willing to give written informed consent. Sampling procedure: Simple random sampling by computerized table method. Type of study: Interventional study. Study design: Randomized standard controlled single-blind superiority clinical trial. Simple randomization method will be used to allocate participants in controlled and interventional group. A Random number generator will be used and unique number is given to each participant. Participant with even number will be allocated in controlled group and participant with odd number will be allocated in Interventional group. Data monitoring: formal committee. Ethical considerations The ethical clearance for the publication of this protocol was taken from the I.E.C. committee at Mahatma Gandhi Ayurveda College, Hospital and Research Centre Salod (H), Wardha, Datta Meghe Institute of Medical Sciences with Ref No.-MGACHRC/IEC/july-2022/549 (11/08/22). CTRI registration for this study – CTRI/2022/12/048534 (27/12/2022). The committee will decide on the endpoint and oversee the trial as it progresses. The researcher will assess any adverse event and these will be reported to the ethics committee. Consent – The recruitment of the patient in study groups will be done with written informed consent in their local language while explaining every aspect of the study by the researcher. Before, during, and after the experiment, the participants’ personal data will be gathered and kept private. The researcher will be the only one having access to the physical data storage facility. Computerised information will be kept on a hard drive that is password-protected and only the researcher can access it. Inclusion criteria – Patients willing to participate with written informed consent. Patients aged between 20–60 yrs. Patients having classical sign and symptoms of Grudhrasi Ruk (pain), Stambha (stiffness), Toda (pricking pain), Muhuspandana (numbness), Aruchi (anorexia), Tandra (drowsiness). Patient fulfilling diagnostic criteria like positive SLRT, Schober’s test, Bowstring Test. Exclusion criteria – Cases of traumatic injury. Known cases of bone tumour, cancer of spine, tuberculosis of vertebral column, fibrosis of sacral ligaments, and protruded inter vertebral disc except lumbar spondylosis. Patients with serious health issues such as diabetes mellitus, heart disease, kidney disease, cancer, tuberculosis, and other systemic disorders. Pregnant and lactating women. Withdrawal criteria If any unintended adverse effects or complications develop while receiving therapy, the patient will be removed from study and receive free care for those issues until they are resolved. Intervention description Group B (Interventional group) – Rasonapinda 12 500 mg twice a day with water Ingredients of Rasonapinda are Allium sativum (Rasona 72 gm), Ferula asafetida (Hingu 12 gm), Cuminum cyminum (Jeeraka 12 gm), Sodiichloridum (Saindhavlavana and Souvarchalalavana 12 gm each), zingiber officinale (Shunthi 12 gm), Piper nigrum (Maricha 12 gm), Piper longum (Pippali 12gm), Ricinus communis (Eranda- Quantity sufficient). Group A (Controlled group) – Trayodashang guggul 13 , 14 500 mg twice a day with water Ingredients of Trayodashang guggul are 13 parts Commiphoramukul (Guggul), 1 part of each -Acasia Arabica (Aabha), Withaniasomnifera (Ashwagandha), Juniperus communis (Harpusha), Tinospora cordifolia (Guduchi), Asparagus recemosus (Shatavari), Tribulus terresteris (Gokshur), Argyria speciosa (Vriddhadaru), Pluchea lanceolata (Rasna), Foeniculumvalgare (Shatapushpa), Curcuma zedoaria (Karchur), Trachhyspermumammi (Yavani), Zingiber officinale (Shunthi), 1/2 part of Clarified butter (Ghrut). Adjuvent Therapy – katibasti (oil pooling therapy) with Dashmoola oil Dashmoola oil literally means oil prepared of 10 roots of medicinal herb is a polyherbal preparation pacifying all three bodily humours ( vata, pitta and kapha ), more specifically having vata pacifying effect mentioned in bhaishajyaratnavali under the management of brain disorders ( Shirorogadhikar ). It is a well-known for alleviating Vata type of bodily humour by oleation therapy. 15 Ingredients of Dashmool oil are 1 part each of roots of Aegle marmelos (Bilwa), Premna serratifolia (Agnimantha), Oroxylum indicum (Shyonak), Stereospermum suaveolance (Patala), Gmelina arborea (Gambhari), Desmodiumgangeticum (Shalaparni), Uraria picta ( Prishniparni), Solanum indicum (Brihati), Solanum surattense (Kantakari), Tribulus terrestris (Gokshura), Vitex negundo (Nirgundi), Brassica comprestris (Sarshap). Drug preparation Rasonapinda will be prepared according to the standard operating procedures outlined in Sharangdhar Samhita- Madhyam Khand (ayurveda classics). Rasonapinda will be prepared according to modified form by giving three bhavanas (triturations) of erandmool decoction and converting it into tablet form for easy acceptability and convenience to the patient and further standardization of Rasona Pinda will be done. 16 Procedure of Rasona Pinda preparation Fine powder of all ingredients- Allium sativum (Rasona 72 gm), Ferula asafetida (Hingu 12 gm), Cuminum cyminum (Jeeraka 12 gm), Sodiichloridum (Saindhavlavana and Souvarchalalavana 12 gm each), zingiber officinale (Shunthi 12 gm), Piper nigrum (Maricha 12 gm), Piper longum (Pippali 12 gm) will be taken and mixed thoroughly. To this powder, ricinus communis root (erandmool) decoction will be added and triturated for three hours. Such three triturations ( bhavanas ) will be given. After drying granules will be prepared and tablet of each 250 mg will be prepared by tablet punching machine. Trayodashang Guggul and Dashmool Taila will be procured from a pharmaceutical company. Intervention modification Any unfavourable effects during the course of the treatment will be observed and will be reported to the ethical committee. The patients’ unpleasant effects will be taken care of. Any withdrawal requests from participants will be addressed along with the justification for ending the course of therapy. Outcomes To compare efficacy of Rasonapinda and Trayodashang guggul as an adjuvant to katibasti (oil pooling therapy) in subjective and objective parameters. Assessment criteria Assessment will be done on 0 th , 15 th , 30 th day during treatment and 45 th day after treatment Subjective criteria – Gradation 17 Ruk (pain) Stambha (stiffness) Toda (pricking pain) Muhuspandana (numbness) Aruchi (anorexia) Tandra (drowsiness) Functional disability – Oswestry Disability Assessment Questionnaire Objective criteria – (before and after) SLRT (Straight Leg Raising test) Walking time – to cover 25 meters Schober’s Test Bowstring test Oswestry Low Back Pain Disability Questionnaire 18 Questionnaire description: Each of the 10 sections that describe the pain and its effects is evaluated from 0 to 5, with higher values indicating a more severe impact. Schober’s test Locate L5 spinous process (level of posterior superior illiac spine, dimpuls of venus). Mark 5 cm below and 10 cm above. Requesting the patient to touch their toes. Measure the space between the marks. Normal > 5 cm, Abnormal< 2.5 cm Bowstring test Subject is supine. Passively perform SLR on the involved side, if the pain is experienced, flex the subject’s knee to 20 degrees in attempt to reduce the pain. After that, exert pressure there in an effort to simulate radicular pain. (+) Tension on the sciatic nerve is indicated by painful radicular reproduction after popliteal compression. Participant timeline Patients will be treated for 30 days and assessment will be done up to 45 days as mentioned in Figure 1 . Figure 1. CONSORT flow diagram showing study timeline. Recruitment As per sample size calculation, total patients will be recruited. Data collected will be analyzed by using appropriate statistical methods. The patients of Grudhrasi will be selected from the Kayachikitsa Out-patient department and In-patient department of Mahatma Gandhi Ayurved College, Hospital & Research Centre, Salod (H), and from specialized peripheral camps. Enrolment and interventions time schedule The intervention period will be from 0 to 30 days and follow up on the 0 th , 15 th , 30 th and 45 th day. Sample size Formula using Mean difference: n 1 = n 2 = 2 Z α + Z β 2 σ 2 δ 2 Z α = 1.96 α = Type I error at 5% at both sides two tailed Z β = 0.84 = Power at 80% Primary Variable = Radiation of Pain (Mean) value of Radiation of Pain for Trayodashangguggul treatment group (Before) = 2.27 (As per reference article). 19 (Mean) value of Radiation of Pain for Trayodashangguggul treatment group (After) = 0.93. Mean Difference for the effect in Trayodashangguggul after and before 2.27 – 0.93 = 1.34. Standard Deviation = 0.62 Considering 20% clinically relevant margin for RasonaPinda δ = (1.34 *35) /100 = 0.469. Sample size N = n 1 = n 2 = 2 1.96 + 0.84 2 0.62 2 0.469 2 = 28 per group Considering 10% drop out = 2 Total sample size required = 28 + 2 = 30 per group. A total of 60 patients will be recruited for the study. Allocation sequence generation – Computer-Generated Randomization. Concealment of allocation – assessor blinding. Allocation implementation – the first author will generate an allocation sequence, enrol participants, and assign participants to intervention. Blinding – randomized single blind standard controlled superiority clinical trial. The outcome assessor will be blinded. Unblinding will not be permissible to outcome assessor. Participant will be revealed about allocation of intervention at the time of enrolment. Data collection plan Data will be record and assessed as per the subjective and objective criteria on 0 th , 15 th , 30 th & 45 th of study (see Table 1 ). Table 1. The plan for collection of data. Group Sample size Intervention Dose and frequency Anupan Duration Follow Up A 30 Trayodashang Guggul 500 mg Twice a day after meal Warm Water 30 days 0 th ,15 th , 30 th day during treatment 45 th day after treatment B 30 RasonaPinda 500 mg twice a day after meal Warm water 30 days Katibasti (oil pooling therapy) with Dashmool oil in both groups Initial 7 days Ayurveda samhitas Modern texts Online search – Google scholar, etc. 60 patients TrayodashangGuggul RasonaPinda Case record form Patients information form Written and informed consent form Measuring scale Sphyghmomanometer Weighing machine Data obtained from the follow up chart and other observations will be used and the results will be drawn on the basis of various charts, graphs, and tables. To determine the relevance of the findings, improvement in patient condition as per assessment criteria, after treatment will be noted as significant. Drug collection/authentication The department of Dravyaguna and Rasashastra of Mahatma Gandhi Ayurved college hospital and Research Center, Salod, Wardha will validate and identify the raw material before it is used to make the medicine. It will be obtained from a reputable source. Statistical methods Descriptive statistics will summarize baseline characteristics. Baseline comparisons between groups will be conducted using independent t-tests for continuous variables and Chi-square tests for categorical variables. Primary outcome analysis will involve paired t-tests (or Wilcoxon signed-rank tests) within each group to evaluate changes from baseline, and independent t-tests (or Mann-Whitney U tests) to compare changes between groups. Secondary outcomes will be analyzed using repeated measures ANOVA or mixed-effects models for longitudinal data, and Chi-square tests for categorical outcomes. Regression analyses will adjust for potential confounders. Study status IEC Clearance and CTRI registration has been done. Recruitment of patient has started as per the inclusion and exclusion criteria. Discussion This study will compare the therapeutic efficacy of Trayodashang guggul and Rasonapinda adjuvant to katibasti (oil pooling therapy) in individuals with grudhrasi (sciatica). Grudhrasi has been mentioned in classics in ayurveda under vatavyadhi (neurological disorders caused by Vata, one of the bodily humour) where there is radiating pain along with stiffness in buttocks (sphik) that gradually encroaches posterior aspect of lumbosacral region radiating to the thigh, popliteal area, calf up to the foot sequentially. In ayurveda, treatment means to disintegrates the pathogenesis (samprapti). 20 In grudhrasi there is mainly vitiation of vata humour along with kapha humour. 21 Also, there is derangement of digestive strength with vitiation of bones and muscles and ligaments by their improper nourishment which gives rise to the above-mentioned symptoms. The quality of drugs for disintegration of disease pathogenesis should include vata and kapha pacifying action and which also nourishes the body tissues. 22 Trayodashang Guggul is a polyherbal formulation mentioned in ayurveda in which 13 herbs, including guggul , are combined to make Trayodashang Guggul , which is then processed in ghrut (Ghee). Specifically, constituents like Asparagus racemosus (shatavari ) , Winthania somnifera (Ashvagandha ) and Tinospora cordifolia (guduchi ) are known as rejuvenators and provides strength to body tissues. 23 Trayodashang guggul also have proven anti-inflammatory action. Additionally Ghrut (Ghee) with its catalytic and synergistic action helps in better penetration and absorption of drug. 24 Thus trayodashng guggul directly has an impact in disintegration of disease pathogenesis and pacifying vata humour. Rasona Pinda has been mentioned in Bhaisajya Ratnavali (Ayurveda classics) which consists of Rasona ( Allium sativum ) , Trikatu (combination of zingiber officinale , Piper nigrum and Piper longum ) and errand ( Ricinus communis ) as chief ingredients possessing a mainly pungent taste (katu, one of the six taste in ayurveda) and hot in potency. 25 Allium sativum is a well-known Kapha and Vata humour pacifying drug. Rasona has rejuvenating action ( Rasayan ). Being rejuvenating, this medication raise the standard of healthy body tissue production and restored normalcy to the vitiation of bone and tissues. Trikatu (combination of zingiber officinale , Piper nigrum and Piper longum ) helps in Ama toxin (undigested food) digestion and enhances digestive fire with its hot potency. 26 Trikatu (combination of zingiber officinale , Piper nigrum and Piper longum ) has also been shown to be helpful for musculoskeletal diseases, reducing stiffness and swelling. 27 Additionally Rasona Pinda tablet given is tritutrated with decoction of roots of Ricinus communis ( erandmula ). Ricinus communis (erandmula) being sweet , pungent , astringent in taste and unctuous in nature with hot potency will help in combating vitiated vata-kapha bodily humour. 28 Kati Basti (oil pooling therapy) with Dashmoola oil (combination of the roots of 10 herbal drugs) relieves stress from muscles and bones, allowing the Srotas (inner channels of body) to function more efficiently. 29 It also aids in improved blood circulation and provides flexibility in body movement. Ingredients of Dashamula (combination of the roots of 10 herbal drugs) have Vata and Kapha humour pacifying properties and also possess anti-inflammatory and analgesic action which provides relief from muscular and skeletal discomfort in the back. 30 Conclusion The trial drug could be efficacious in treating grudhrasi (sciatica) as it is a combination of drugs having anti-inflammatory , pain alleviating , rejuvenating and digestive fire strengthening properties that could be helpful in disintegration of pathogenesis. Scope and implications of the proposed study If RasonaPinda will pacify the symptoms in Grudhrasi (sciatica) and is found to be helpful to perform routine activities then clinical evidence with simple, safe, cost-effective treatment can be generated for the management of Grudhrasi (sciatica). Dissemination This protocol will be further published as a thesis to disseminate the study for Grudhrasi (sciatica). The study protocol provides a detailed overview of the study design, methodology, data collection procedures, data analysis plan, and ethical considerations. By disseminating this protocol, we hope to advance knowledge in the field and facilitate future research. Note The study demonstrates the effectiveness of “Ayurveda,” an old practice practised in several regions of India. If it is determined that this ancient idea is appropriate, it should be thoroughly assessed and partially implemented. Data availability Underlying data No data are associated with this article. Reporting guidelines Zenodo: SPIRIT checklist for ‘Comparative evaluation of efficacy of Trayodashang Guggul versus Rasona Pinda as an adjuvant with Katibasti in the management of Grudhrasi (Sciatica): A randomized controlled trial’. https://doi.org/10.5281/zenodo.8126753 . 27 Data are available under the terms of the Creative Commons Attribution 4.0 International license (CC-BY 4.0). Acknowledgements I am thankful to my guide, seniors and batchmates for supporting me in publishing this work. The authors are also appreciative of the authors, editors, and publishers of all the papers, journals, and books that were used to review and debate the literature for this work. References 1. Acharya JT: Charaka Samhita of Agnivesha, Chikitasthana, Ch. 28, Ver. 56-57. 4th ed.Varanasi: Chaukhambha Surbharati Prakashana; 1994; 619. 2. Acharya JT: Sushruta Samhita of Sushruta, Nidansthana, Ch. 1, Ver. 74. 4th ed.Varanasi: ChaukhambhaPrakashana; 1980; 268. 3. Sathavane GV, Pandya DH, Baghel MS: Effect of Vatari Guggulu in the management of Gridhrasi (sciatica). Ayu. 2015; 36 (1): 41–45. PubMed Abstract | Publisher Full Text | Free Full Text 4. Golwalla AF, Nadkar MY: Golwalla’s medicine for students, Part 14 section 3, Root and plexus syndromes. Pg no 593. 5. http 6. 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Dr. Moharana PK , Dr. Patel A : Synergistic Effect of TrayodashangaGuggulu and Yoga Basti in the Management of Low Back Pain with Special Reference to Gridhrasi. International Journal of Health Sciences & Research. December 2018; 8 (12). Reference Source 25. Ratnavali B: Gobind Das Sen with Vidhyotinihindi commentary by Ambika dutta Shastri, B.R. Vat-vyadhiadhikar, verse-89-90, Edition 1999, published by Chaukhamba Sanskrit Samsthana Varanasi. 26. Charak CS, Vidyotini SK, Chaturvedi GN, editors. Varanasi:Chaukhamba Bharati Academy.2003. 27. Nighantu B, Chunekar KC, Pandey GS, editors. Varanasi: Chaukhamba Vidyabhavan; 1969. Publisher Full Text 28. Sushruta: Sushruta Samhita (NibhandasangrahaCommentary of Dalhanacharya and NyayapanijakaCommentary of Gayadasa). Trikamji editor. 1 st ed.Varanasi: Chaukhamba Sanskrit Samsthan, Sutra Sthana; 2007; Vol. 45 . . 29. Pooja BA, Bhatted IS, Meera K: Bhojani’efficacy Of katibasti And Samanausadhi In The Management Of Grudhrasi (Sciatica) - A Comparative Clinical Studyaryavaidyan.Feb. - Apr. 2015; Vol. Xxviii (3): pp. 173–177. 30. Niteshwar K, Vidyanath R: Sahasrayogam; Taila yoga prakarana. Varanasi, India: Chaukhambha Sanskrit Series Office; 2006; vol. 1 . : 158. Comments on this article Comments (0) Version 3 VERSION 3 PUBLISHED 03 Jan 2024 ADD YOUR COMMENT Comment Author details Author details 1 Datta Meghe Institute of Higher Education & Research, Wardha, Maharashtra, India Mayank Rai Roles: Conceptualization, Data Curation, Formal Analysis, Investigation, Methodology, Resources, Software, Validation, Visualization, Writing – Original Draft Preparation Sadhana Misar Roles: Methodology, Software, Supervision, Validation, Visualization, Writing – Review & Editing Reeya Gamne Roles: Resources Competing interests No competing interests were disclosed. Grant information The author(s) declared that no grants were involved in supporting this work. Article Versions (3) version 3 Revised Published: 12 Aug 2024, 13:9 https://doi.org/10.12688/f1000research.139568.3 version 2 Revised Published: 28 Jun 2024, 13:9 https://doi.org/10.12688/f1000research.139568.2 version 1 Published: 03 Jan 2024, 13:9 https://doi.org/10.12688/f1000research.139568.1 Copyright © 2024 Rai M et al . This is an open access article distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Download Export To Sciwheel Bibtex EndNote ProCite Ref. Manager (RIS) Sente metrics Views Downloads F1000Research - - PubMed Central info_outline Data from PMC are received and updated monthly. - - Citations open_in_new 0 open_in_new 0 open_in_new SEE MORE DETAILS CITE how to cite this article Rai M, Misar S and Gamne R. Comparative evaluation of efficacy of Trayodashang Guggul versus Rasona Pinda as an adjuvant with Katibasti in the management of Grudhrasi (Sciatica): A randomized controlled trial [version 3; peer review: 1 approved, 2 approved with reservations] . F1000Research 2024, 13 :9 ( https://doi.org/10.12688/f1000research.139568.3 ) NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article. COPY CITATION DETAILS track receive updates on this article Track an article to receive email alerts on any updates to this article. TRACK THIS ARTICLE Share Open Peer Review Current Reviewer Status: ? Key to Reviewer Statuses VIEW HIDE Approved The paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved Fundamental flaws in the paper seriously undermine the findings and conclusions Version 3 VERSION 3 PUBLISHED 12 Aug 2024 Revised Views 0 Cite How to cite this report: Bhatta M. Reviewer Report For: Comparative evaluation of efficacy of Trayodashang Guggul versus Rasona Pinda as an adjuvant with Katibasti in the management of Grudhrasi (Sciatica): A randomized controlled trial [version 3; peer review: 1 approved, 2 approved with reservations] . F1000Research 2024, 13 :9 ( https://doi.org/10.5256/f1000research.170138.r328942 ) The direct URL for this report is: https://f1000research.com/articles/13-9/v3#referee-response-328942 NOTE: it is important to ensure the information in square brackets after the title is included in this citation. Close Copy Citation Details Reviewer Report 17 Oct 2024 Maheshwor Bhatta , Swami Vivekananda Yoga Anusandhana Samsthana, Bengaluru, Karnataka, India Approved with Reservations VIEWS 0 https://doi.org/10.5256/f1000research.170138.r328942 The researcher is doing well, but there are many gaps in the research design(some are already corrected) and presentation( more need to work). The writing lacks clarity and resembles a thesis or dissertation rather than a paper. Conducting research and ... Continue reading READ ALL The researcher is doing well, but there are many gaps in the research design(some are already corrected) and presentation( more need to work). The writing lacks clarity and resembles a thesis or dissertation rather than a paper. Conducting research and presenting it as a paper are distinct processes. While I can see the researcher’s good intentions, There are numerous repetitive elements throughout the paper, with some points appearing 6-7 times. The paper should be more concise, with improved readability and flow. Here are some specific points for necessary changes: In the Introduction: There are many grammatical mistakes; please check thoroughly. Verify the citation regarding the claim that 2-40 percent of individuals in India suffer from sciatica. Add a sentence highlighting the necessity of this comparative study—what gap in the current literature or practice is being addressed? This should be placed at the end of the introduction. Some parts of the introduction are repetitive (e.g., mentioning Rasonapinda's role in managing Grudhrasi and its analgesic and anti-inflammatory properties). Please condense this information to avoid redundancy. In Aims and Objectives: Present the Aims and Objectives in a concise paragraph format for better readability and flow. Merging the ideas into a cohesive narrative will capture the essence of the study more clearly. In Methods: (The designation of "randomized controlled single-blind superiority trial" lacks clarity; it appears more like a comparative study. Please specify who is blinded—patients, researchers, or evaluators., Based on your assessment, confirm whether this is a randomized controlled trial. – I got to know that it has already changed, good) Explain why multiple assessments are necessary and their importance in this study. The paper contains several unnecessary points, particularly concerning the instruments of data collection and details about the ethical committee and CTRI, which are mentioned in multiple places. Additionally, the discussion of data collection is repeated in several sections. To enhance the overall flow of the paper, please streamline these areas. Information about sample size and medication is presented in a fragmented manner, with some points appearing earlier and others later. It would be beneficial to consolidate these details into cohesive sections for clarity. Is the rationale for, and objectives of, the study clearly described? Partly Is the study design appropriate for the research question? Partly Are sufficient details of the methods provided to allow replication by others? Partly Are the datasets clearly presented in a useable and accessible format? Partly Competing Interests: No competing interests were disclosed. Reviewer Expertise: Ayurveda, Clinical Yoga I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above. Close READ LESS CITE CITE HOW TO CITE THIS REPORT Bhatta M. Reviewer Report For: Comparative evaluation of efficacy of Trayodashang Guggul versus Rasona Pinda as an adjuvant with Katibasti in the management of Grudhrasi (Sciatica): A randomized controlled trial [version 3; peer review: 1 approved, 2 approved with reservations] . F1000Research 2024, 13 :9 ( https://doi.org/10.5256/f1000research.170138.r328942 ) The direct URL for this report is: https://f1000research.com/articles/13-9/v3#referee-response-328942 NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article. COPY CITATION DETAILS Report a concern Respond or Comment COMMENT ON THIS REPORT Views 0 Cite How to cite this report: Kamath S. Reviewer Report For: Comparative evaluation of efficacy of Trayodashang Guggul versus Rasona Pinda as an adjuvant with Katibasti in the management of Grudhrasi (Sciatica): A randomized controlled trial [version 3; peer review: 1 approved, 2 approved with reservations] . F1000Research 2024, 13 :9 ( https://doi.org/10.5256/f1000research.170138.r313360 ) The direct URL for this report is: https://f1000research.com/articles/13-9/v3#referee-response-313360 NOTE: it is important to ensure the information in square brackets after the title is included in this citation. Close Copy Citation Details Reviewer Report 23 Aug 2024 Shrilatha Kamath , Sri Dharmasthala Manjunatheshwara College of Ayurveda, Udupi, Karanataka, India Approved VIEWS 0 https://doi.org/10.5256/f1000research.170138.r313360 The author has made all the necessary changes except for the title correction, which remains unaddressed. I’m finding it challenging to reiterate this point repeatedly. Therefore, I will step back from further corrections and leave the indexing process to proceed ... Continue reading READ ALL The author has made all the necessary changes except for the title correction, which remains unaddressed. I’m finding it challenging to reiterate this point repeatedly. Therefore, I will step back from further corrections and leave the indexing process to proceed as it is. Thank you for your understanding. Competing Interests: No competing interests were disclosed. Reviewer Expertise: Medicine, Chest, Locomotor, ENT, Skin, Autoimmune I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard. Close READ LESS CITE CITE HOW TO CITE THIS REPORT Kamath S. Reviewer Report For: Comparative evaluation of efficacy of Trayodashang Guggul versus Rasona Pinda as an adjuvant with Katibasti in the management of Grudhrasi (Sciatica): A randomized controlled trial [version 3; peer review: 1 approved, 2 approved with reservations] . F1000Research 2024, 13 :9 ( https://doi.org/10.5256/f1000research.170138.r313360 ) The direct URL for this report is: https://f1000research.com/articles/13-9/v3#referee-response-313360 NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article. COPY CITATION DETAILS Report a concern Respond or Comment COMMENT ON THIS REPORT Version 2 VERSION 2 PUBLISHED 28 Jun 2024 Revised Views 0 Cite How to cite this report: Kamath S. Reviewer Report For: Comparative evaluation of efficacy of Trayodashang Guggul versus Rasona Pinda as an adjuvant with Katibasti in the management of Grudhrasi (Sciatica): A randomized controlled trial [version 3; peer review: 1 approved, 2 approved with reservations] . F1000Research 2024, 13 :9 ( https://doi.org/10.5256/f1000research.167923.r296928 ) The direct URL for this report is: https://f1000research.com/articles/13-9/v2#referee-response-296928 NOTE: it is important to ensure the information in square brackets after the title is included in this citation. Close Copy Citation Details Reviewer Report 29 Jul 2024 Shrilatha Kamath , Sri Dharmasthala Manjunatheshwara College of Ayurveda, Udupi, Karanataka, India Approved with Reservations VIEWS 0 https://doi.org/10.5256/f1000research.167923.r296928 These were my earlier Suggestions: 1.Review of the article: Comparative evaluation of efficacy of Trayodashang Guggul versus Rasona Pinda as an adjuvant with Katibasti in the management of Grudhrasi (Sciatica): A randomized controlled trial Title itself is ambiguous- Comparative and controlled words are totally different. This study ... Continue reading READ ALL These were my earlier Suggestions: 1.Review of the article: Comparative evaluation of efficacy of Trayodashang Guggul versus Rasona Pinda as an adjuvant with Katibasti in the management of Grudhrasi (Sciatica): A randomized controlled trial Title itself is ambiguous- Comparative and controlled words are totally different. This study seems like a comparative study as there is no controlled drug specified 2. Allocation method is not mentioned. Type of randomising method into two groups has to be mentioned (such as simple or permuted block randomisation etc.) 3. In methodology, inclusion criteria- Patients having classical signs and symptoms cannot be mentioned. it has to be specific (2-4). Diagnosis cant rely on presence or absence of all the subjective and objective criteria mentioned. 4. In exclusion criteria IVDP is mentioned. But to exclude MRI is compulsory. As no investigations done is mentioned in the article it cannot be considered. Author has to specify whether only Lumbar spondylosis is included. Observations Present Title is still not rectified Comparative evaluation of efficacy of Trayodashang Guggul versus Rasona Pinda as an adjuvant with Katibasti in the management of Grudhrasi (Sciatica): A randomized controlled trial Methods- Not corrected Study setting The patients will be selected from Kayachikitsa Out-patient department (OPD) and In-patient department (IPD) of the Mahatma Gandhi Ayurved College, Hospital & Research Centre, Salod (H) and peripheral camps, mainly the population of Wardha district including patients of all community, (Maharashtra) India. A total of 60 patients will be recruited for the study. They will randomly be divided into two groups; Group A – Trayodashang Guggul , and Group B – s Rasona Pinda. Patients having classical sign and symptoms of Grudhrasi Ruk (pain), Stambha (stiffness), Toda (pricking pain), Muhuspandana (numbness), Aruchi (anorexia), Tandra (drowsiness). Patient fulfilling diagnostic criteria like positive SLRT, Schober’s test, Bowstring Test. Exclusion criteria – Cases of traumatic injury. Known cases of bone tumour, cancer of spine, tuberculosis of vertebral column, fibrosis of sacral ligaments, and protruded inter vertebral disc except lumbar spondylosis Competing Interests: No competing interests were disclosed. Reviewer Expertise: Medicine, Chest, Locomotor, ENT, Skin, Autoimmune I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above. Close READ LESS CITE CITE HOW TO CITE THIS REPORT Kamath S. Reviewer Report For: Comparative evaluation of efficacy of Trayodashang Guggul versus Rasona Pinda as an adjuvant with Katibasti in the management of Grudhrasi (Sciatica): A randomized controlled trial [version 3; peer review: 1 approved, 2 approved with reservations] . F1000Research 2024, 13 :9 ( https://doi.org/10.5256/f1000research.167923.r296928 ) The direct URL for this report is: https://f1000research.com/articles/13-9/v2#referee-response-296928 NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article. COPY CITATION DETAILS Report a concern Author Response 12 Aug 2024 Mayank Rai , Datta Meghe Institute of Higher Education & Research, Wardha, India 12 Aug 2024 Author Response Respected Ma'am, I have changed the study setting and mentioned controlled group & interventional group, as suggested by you and also made necessary correction as suggested. University SRC Committee ... Continue reading Respected Ma'am, I have changed the study setting and mentioned controlled group & interventional group, as suggested by you and also made necessary correction as suggested. University SRC Committee suggested title. I have tried making all the correction suggested by you. Please look after the changes and do the needful. Respected Ma'am, I have changed the study setting and mentioned controlled group & interventional group, as suggested by you and also made necessary correction as suggested. University SRC Committee suggested title. I have tried making all the correction suggested by you. Please look after the changes and do the needful. Competing Interests: No competing interests were disclosed. Close Report a concern Respond or Comment COMMENTS ON THIS REPORT Author Response 12 Aug 2024 Mayank Rai , Datta Meghe Institute of Higher Education & Research, Wardha, India 12 Aug 2024 Author Response Respected Ma'am, I have changed the study setting and mentioned controlled group & interventional group, as suggested by you and also made necessary correction as suggested. University SRC Committee ... Continue reading Respected Ma'am, I have changed the study setting and mentioned controlled group & interventional group, as suggested by you and also made necessary correction as suggested. University SRC Committee suggested title. I have tried making all the correction suggested by you. Please look after the changes and do the needful. Respected Ma'am, I have changed the study setting and mentioned controlled group & interventional group, as suggested by you and also made necessary correction as suggested. University SRC Committee suggested title. I have tried making all the correction suggested by you. Please look after the changes and do the needful. Competing Interests: No competing interests were disclosed. Close Report a concern COMMENT ON THIS REPORT Version 1 VERSION 1 PUBLISHED 03 Jan 2024 Views 0 Cite How to cite this report: Bapat V. Reviewer Report For: Comparative evaluation of efficacy of Trayodashang Guggul versus Rasona Pinda as an adjuvant with Katibasti in the management of Grudhrasi (Sciatica): A randomized controlled trial [version 3; peer review: 1 approved, 2 approved with reservations] . F1000Research 2024, 13 :9 ( https://doi.org/10.5256/f1000research.152851.r281463 ) The direct URL for this report is: https://f1000research.com/articles/13-9/v1#referee-response-281463 NOTE: it is important to ensure the information in square brackets after the title is included in this citation. Close Copy Citation Details Reviewer Report 20 Jun 2024 Vaibhav Bapat , National Institute of Ayurveda Deemed University, Jaipur, Rajasthan, India Approved with Reservations VIEWS 0 https://doi.org/10.5256/f1000research.152851.r281463 The work done by the authors to construct this protocol is admirable. There is a demand for complete language editing. Please reconsider the title because control trials are referenced in the title but no specifics about the control group are ... Continue reading READ ALL The work done by the authors to construct this protocol is admirable. There is a demand for complete language editing. Please reconsider the title because control trials are referenced in the title but no specifics about the control group are available anywhere. There might be better optional keywords. Aushadh Sevan Kala is not mentioned. Details of the Katibasti procedure with SOP must be included in this protocol. The inclusion and exclusion criteria appear insufficient. The patient's sex is not mentioned, however pregnant and breastfeeding women are noted in the exclusion criteria. Because the protocol is for 30 days, it is vital to mention whether the katibasti procedure will be continued or discontinued during menstruation. The discussion is written as the study has already been conducted; rather, it should be in accordance with the protocol and should explore the possibility of positive and negative consequences. Is the rationale for, and objectives of, the study clearly described? Partly Is the study design appropriate for the research question? Partly Are sufficient details of the methods provided to allow replication by others? No Are the datasets clearly presented in a useable and accessible format? Yes Competing Interests: No competing interests were disclosed. Reviewer Expertise: Ayurveda, Skin diseases, Musculoskeletal disorders I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above. Close READ LESS CITE CITE HOW TO CITE THIS REPORT Bapat V. Reviewer Report For: Comparative evaluation of efficacy of Trayodashang Guggul versus Rasona Pinda as an adjuvant with Katibasti in the management of Grudhrasi (Sciatica): A randomized controlled trial [version 3; peer review: 1 approved, 2 approved with reservations] . F1000Research 2024, 13 :9 ( https://doi.org/10.5256/f1000research.152851.r281463 ) The direct URL for this report is: https://f1000research.com/articles/13-9/v1#referee-response-281463 NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article. COPY CITATION DETAILS Report a concern Author Response 28 Jun 2024 Mayank Rai , Datta Meghe Institute of Higher Education & Research, Wardha, India 28 Jun 2024 Author Response Respected Sir/Ma'am, I have made all the corrections suggested to me by you. I have mentioned control and interventional groups. Katibasti taken as adjuvant therapy in the study only for ... Continue reading Respected Sir/Ma'am, I have made all the corrections suggested to me by you. I have mentioned control and interventional groups. Katibasti taken as adjuvant therapy in the study only for initial seven days. Katibasti will be continued in menstruating females as per their consent if given priority to disease symptoms. Thanking you, Yours truly, Mayank Rai PG Scholar MGACH&RC, DMIHER,Wardha Respected Sir/Ma'am, I have made all the corrections suggested to me by you. I have mentioned control and interventional groups. Katibasti taken as adjuvant therapy in the study only for initial seven days. Katibasti will be continued in menstruating females as per their consent if given priority to disease symptoms. Thanking you, Yours truly, Mayank Rai PG Scholar MGACH&RC, DMIHER,Wardha Competing Interests: No competing interests were disclosed. Close Report a concern Respond or Comment COMMENTS ON THIS REPORT Author Response 28 Jun 2024 Mayank Rai , Datta Meghe Institute of Higher Education & Research, Wardha, India 28 Jun 2024 Author Response Respected Sir/Ma'am, I have made all the corrections suggested to me by you. I have mentioned control and interventional groups. Katibasti taken as adjuvant therapy in the study only for ... Continue reading Respected Sir/Ma'am, I have made all the corrections suggested to me by you. I have mentioned control and interventional groups. Katibasti taken as adjuvant therapy in the study only for initial seven days. Katibasti will be continued in menstruating females as per their consent if given priority to disease symptoms. Thanking you, Yours truly, Mayank Rai PG Scholar MGACH&RC, DMIHER,Wardha Respected Sir/Ma'am, I have made all the corrections suggested to me by you. I have mentioned control and interventional groups. Katibasti taken as adjuvant therapy in the study only for initial seven days. Katibasti will be continued in menstruating females as per their consent if given priority to disease symptoms. Thanking you, Yours truly, Mayank Rai PG Scholar MGACH&RC, DMIHER,Wardha Competing Interests: No competing interests were disclosed. Close Report a concern COMMENT ON THIS REPORT Views 0 Cite How to cite this report: Kamath S. Reviewer Report For: Comparative evaluation of efficacy of Trayodashang Guggul versus Rasona Pinda as an adjuvant with Katibasti in the management of Grudhrasi (Sciatica): A randomized controlled trial [version 3; peer review: 1 approved, 2 approved with reservations] . F1000Research 2024, 13 :9 ( https://doi.org/10.5256/f1000research.152851.r281465 ) The direct URL for this report is: https://f1000research.com/articles/13-9/v1#referee-response-281465 NOTE: it is important to ensure the information in square brackets after the title is included in this citation. Close Copy Citation Details Reviewer Report 11 Jun 2024 Shrilatha Kamath , Sri Dharmasthala Manjunatheshwara College of Ayurveda, Udupi, Karanataka, India Approved with Reservations VIEWS 0 https://doi.org/10.5256/f1000research.152851.r281465 Review of the article: Comparative evaluation of efficacy of Trayodashang Guggul versus Rasona Pinda as an adjuvant with Katibasti in the management of Grudhrasi (Sciatica): A randomized controlled trial 1. Title itself is ambiguous- Comparative and controlled words are totally different. This study seems like a ... Continue reading READ ALL Review of the article: Comparative evaluation of efficacy of Trayodashang Guggul versus Rasona Pinda as an adjuvant with Katibasti in the management of Grudhrasi (Sciatica): A randomized controlled trial 1. Title itself is ambiguous- Comparative and controlled words are totally different. This study seems like a comparative study as there is no controlled drug specified 2. Allocation method is not mentioned. Type of randomizing method into two groups has to be mentioned (such as simple or permuted block randomization etc.) 3. In methodology, inclusion criteria- Patients having classical signs and symptoms cannot be mentioned. it has to be specific (2-4). Diagnosis can't rely on presence or absence of all the subjective and objective criteria mentioned. 4. In exclusion criteria IVDP is mentioned. But to exclude MRI is compulsory. As no investigations done is mentioned in the article it cannot be considered. Author has to specify whether only Lumbar spondylosis is included. 5. Throughout the study assessment is mentioned on 0,15,45 days. But in the Participant timeline- it is written as: Patients will be treated for 60 days and assessment will be done up to 90 days as mentioned in.... which doesn't match at all. 6. Statistical test: "As the study is randomized controlled trial, both parametric and non parametric tests like independent t-test, paired t-test, and Man-Whitney statistical test will be applied to the data generated": a. This study is neither randomized nor controlled b. Non Parametric test has to be Wilcoxon signed rank test and Mann Whitney along with t test Is the rationale for, and objectives of, the study clearly described? Partly Is the study design appropriate for the research question? Partly Are sufficient details of the methods provided to allow replication by others? Partly Are the datasets clearly presented in a useable and accessible format? Partly References 1. Rai M, Misar S, Gamne R: Comparative evaluation of efficacy of Trayodashang Guggul versus Rasona Pinda as an adjuvant with Katibasti in the management of Grudhrasi (Sciatica): A randomized controlled trial. F1000Research . 2024; 13 . Publisher Full Text Competing Interests: No competing interests were disclosed. Reviewer Expertise: MedicineKayachikitsa I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above. Close READ LESS CITE CITE HOW TO CITE THIS REPORT Kamath S. Reviewer Report For: Comparative evaluation of efficacy of Trayodashang Guggul versus Rasona Pinda as an adjuvant with Katibasti in the management of Grudhrasi (Sciatica): A randomized controlled trial [version 3; peer review: 1 approved, 2 approved with reservations] . F1000Research 2024, 13 :9 ( https://doi.org/10.5256/f1000research.152851.r281465 ) The direct URL for this report is: https://f1000research.com/articles/13-9/v1#referee-response-281465 NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article. COPY CITATION DETAILS Report a concern Author Response 28 Jun 2024 Mayank Rai , Datta Meghe Institute of Higher Education & Research, Wardha, India 28 Jun 2024 Author Response Respected Mam/sir I have made all the necessary corrections suggested by you. I have specified the sampling procedure,inclusion-exclusion criteria, statistical analysis plan, study duration, and rest of corrections. kindly please ... Continue reading Respected Mam/sir I have made all the necessary corrections suggested by you. I have specified the sampling procedure,inclusion-exclusion criteria, statistical analysis plan, study duration, and rest of corrections. kindly please consider my manuscript for further proceedings. thanking you your's faithfully Mayank Rai PG Scholar MGACH&RC Datta meghe institute of higher education & research center Respected Mam/sir I have made all the necessary corrections suggested by you. I have specified the sampling procedure,inclusion-exclusion criteria, statistical analysis plan, study duration, and rest of corrections. kindly please consider my manuscript for further proceedings. thanking you your's faithfully Mayank Rai PG Scholar MGACH&RC Datta meghe institute of higher education & research center Competing Interests: No competing interests were disclosed. Close Report a concern Respond or Comment COMMENTS ON THIS REPORT Author Response 28 Jun 2024 Mayank Rai , Datta Meghe Institute of Higher Education & Research, Wardha, India 28 Jun 2024 Author Response Respected Mam/sir I have made all the necessary corrections suggested by you. I have specified the sampling procedure,inclusion-exclusion criteria, statistical analysis plan, study duration, and rest of corrections. kindly please ... Continue reading Respected Mam/sir I have made all the necessary corrections suggested by you. I have specified the sampling procedure,inclusion-exclusion criteria, statistical analysis plan, study duration, and rest of corrections. kindly please consider my manuscript for further proceedings. thanking you your's faithfully Mayank Rai PG Scholar MGACH&RC Datta meghe institute of higher education & research center Respected Mam/sir I have made all the necessary corrections suggested by you. I have specified the sampling procedure,inclusion-exclusion criteria, statistical analysis plan, study duration, and rest of corrections. kindly please consider my manuscript for further proceedings. thanking you your's faithfully Mayank Rai PG Scholar MGACH&RC Datta meghe institute of higher education & research center Competing Interests: No competing interests were disclosed. Close Report a concern COMMENT ON THIS REPORT Comments on this article Comments (0) Version 3 VERSION 3 PUBLISHED 03 Jan 2024 ADD YOUR COMMENT Comment keyboard_arrow_left keyboard_arrow_right Open Peer Review Reviewer Status info_outline Alongside their report, reviewers assign a status to the article: Approved The paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved Fundamental flaws in the paper seriously undermine the findings and conclusions Reviewer Reports Invited Reviewers 1 2 3 Version 3 (revision) 12 Aug 24 read read Version 2 (revision) 28 Jun 24 read Version 1 03 Jan 24 read read Shrilatha Kamath , Sri Dharmasthala Manjunatheshwara College of Ayurveda, Udupi, India Vaibhav Bapat , National Institute of Ayurveda Deemed University, Jaipur, India Maheshwor Bhatta , Swami Vivekananda Yoga Anusandhana Samsthana, Bengaluru, India Comments on this article All Comments (0) Add a comment Sign up for content alerts Sign Up You are now signed up to receive this alert Browse by related subjects keyboard_arrow_left Back to all reports Reviewer Report 0 Views copyright © 2024 Bhatta M. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. 17 Oct 2024 | for Version 3 Maheshwor Bhatta , Swami Vivekananda Yoga Anusandhana Samsthana, Bengaluru, Karnataka, India 0 Views copyright © 2024 Bhatta M. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. format_quote Cite this report speaker_notes Responses (0) Approved With Reservations info_outline Alongside their report, reviewers assign a status to the article: Approved The paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved Fundamental flaws in the paper seriously undermine the findings and conclusions The researcher is doing well, but there are many gaps in the research design(some are already corrected) and presentation( more need to work). The writing lacks clarity and resembles a thesis or dissertation rather than a paper. Conducting research and presenting it as a paper are distinct processes. While I can see the researcher’s good intentions, There are numerous repetitive elements throughout the paper, with some points appearing 6-7 times. The paper should be more concise, with improved readability and flow. Here are some specific points for necessary changes: In the Introduction: There are many grammatical mistakes; please check thoroughly. Verify the citation regarding the claim that 2-40 percent of individuals in India suffer from sciatica. Add a sentence highlighting the necessity of this comparative study—what gap in the current literature or practice is being addressed? This should be placed at the end of the introduction. Some parts of the introduction are repetitive (e.g., mentioning Rasonapinda's role in managing Grudhrasi and its analgesic and anti-inflammatory properties). Please condense this information to avoid redundancy. In Aims and Objectives: Present the Aims and Objectives in a concise paragraph format for better readability and flow. Merging the ideas into a cohesive narrative will capture the essence of the study more clearly. In Methods: (The designation of "randomized controlled single-blind superiority trial" lacks clarity; it appears more like a comparative study. Please specify who is blinded—patients, researchers, or evaluators., Based on your assessment, confirm whether this is a randomized controlled trial. – I got to know that it has already changed, good) Explain why multiple assessments are necessary and their importance in this study. The paper contains several unnecessary points, particularly concerning the instruments of data collection and details about the ethical committee and CTRI, which are mentioned in multiple places. Additionally, the discussion of data collection is repeated in several sections. To enhance the overall flow of the paper, please streamline these areas. Information about sample size and medication is presented in a fragmented manner, with some points appearing earlier and others later. It would be beneficial to consolidate these details into cohesive sections for clarity. Is the rationale for, and objectives of, the study clearly described? Partly Is the study design appropriate for the research question? Partly Are sufficient details of the methods provided to allow replication by others? Partly Are the datasets clearly presented in a useable and accessible format? Partly Competing Interests No competing interests were disclosed. Reviewer Expertise Ayurveda, Clinical Yoga I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above. reply Respond to this report Responses (0) Bhatta M. Peer Review Report For: Comparative evaluation of efficacy of Trayodashang Guggul versus Rasona Pinda as an adjuvant with Katibasti in the management of Grudhrasi (Sciatica): A randomized controlled trial [version 3; peer review: 1 approved, 2 approved with reservations] . F1000Research 2024, 13 :9 ( https://doi.org/10.5256/f1000research.170138.r328942) NOTE: it is important to ensure the information in square brackets after the title is included in this citation. The direct URL for this report is: https://f1000research.com/articles/13-9/v3#referee-response-328942 keyboard_arrow_left Back to all reports Reviewer Report 0 Views copyright © 2024 Kamath S. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. 23 Aug 2024 | for Version 3 Shrilatha Kamath , Sri Dharmasthala Manjunatheshwara College of Ayurveda, Udupi, Karanataka, India 0 Views copyright © 2024 Kamath S. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. format_quote Cite this report speaker_notes Responses (0) Approved info_outline Alongside their report, reviewers assign a status to the article: Approved The paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved Fundamental flaws in the paper seriously undermine the findings and conclusions The author has made all the necessary changes except for the title correction, which remains unaddressed. I’m finding it challenging to reiterate this point repeatedly. Therefore, I will step back from further corrections and leave the indexing process to proceed as it is. Thank you for your understanding. Competing Interests No competing interests were disclosed. Reviewer Expertise Medicine, Chest, Locomotor, ENT, Skin, Autoimmune I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard. reply Respond to this report Responses (0) Kamath S. Peer Review Report For: Comparative evaluation of efficacy of Trayodashang Guggul versus Rasona Pinda as an adjuvant with Katibasti in the management of Grudhrasi (Sciatica): A randomized controlled trial [version 3; peer review: 1 approved, 2 approved with reservations] . F1000Research 2024, 13 :9 ( https://doi.org/10.5256/f1000research.170138.r313360) NOTE: it is important to ensure the information in square brackets after the title is included in this citation. The direct URL for this report is: https://f1000research.com/articles/13-9/v3#referee-response-313360 keyboard_arrow_left Back to all reports Reviewer Report 0 Views copyright © 2024 Kamath S. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. 29 Jul 2024 | for Version 2 Shrilatha Kamath , Sri Dharmasthala Manjunatheshwara College of Ayurveda, Udupi, Karanataka, India 0 Views copyright © 2024 Kamath S. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. format_quote Cite this report speaker_notes Responses (1) Approved With Reservations info_outline Alongside their report, reviewers assign a status to the article: Approved The paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved Fundamental flaws in the paper seriously undermine the findings and conclusions These were my earlier Suggestions: 1.Review of the article: Comparative evaluation of efficacy of Trayodashang Guggul versus Rasona Pinda as an adjuvant with Katibasti in the management of Grudhrasi (Sciatica): A randomized controlled trial Title itself is ambiguous- Comparative and controlled words are totally different. This study seems like a comparative study as there is no controlled drug specified 2. Allocation method is not mentioned. Type of randomising method into two groups has to be mentioned (such as simple or permuted block randomisation etc.) 3. In methodology, inclusion criteria- Patients having classical signs and symptoms cannot be mentioned. it has to be specific (2-4). Diagnosis cant rely on presence or absence of all the subjective and objective criteria mentioned. 4. In exclusion criteria IVDP is mentioned. But to exclude MRI is compulsory. As no investigations done is mentioned in the article it cannot be considered. Author has to specify whether only Lumbar spondylosis is included. Observations Present Title is still not rectified Comparative evaluation of efficacy of Trayodashang Guggul versus Rasona Pinda as an adjuvant with Katibasti in the management of Grudhrasi (Sciatica): A randomized controlled trial Methods- Not corrected Study setting The patients will be selected from Kayachikitsa Out-patient department (OPD) and In-patient department (IPD) of the Mahatma Gandhi Ayurved College, Hospital & Research Centre, Salod (H) and peripheral camps, mainly the population of Wardha district including patients of all community, (Maharashtra) India. A total of 60 patients will be recruited for the study. They will randomly be divided into two groups; Group A – Trayodashang Guggul , and Group B – s Rasona Pinda. Patients having classical sign and symptoms of Grudhrasi Ruk (pain), Stambha (stiffness), Toda (pricking pain), Muhuspandana (numbness), Aruchi (anorexia), Tandra (drowsiness). Patient fulfilling diagnostic criteria like positive SLRT, Schober’s test, Bowstring Test. Exclusion criteria – Cases of traumatic injury. Known cases of bone tumour, cancer of spine, tuberculosis of vertebral column, fibrosis of sacral ligaments, and protruded inter vertebral disc except lumbar spondylosis Competing Interests No competing interests were disclosed. Reviewer Expertise Medicine, Chest, Locomotor, ENT, Skin, Autoimmune I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above. reply Respond to this report Responses (1) Author Response 12 Aug 2024 Mayank Rai, Datta Meghe Institute of Higher Education & Research, Wardha, India Respected Ma'am, I have changed the study setting and mentioned controlled group & interventional group, as suggested by you and also made necessary correction as suggested. University SRC Committee suggested title. I have tried making all the correction suggested by you. Please look after the changes and do the needful. View more View less Competing Interests No competing interests were disclosed. reply Respond Report a concern Kamath S. Peer Review Report For: Comparative evaluation of efficacy of Trayodashang Guggul versus Rasona Pinda as an adjuvant with Katibasti in the management of Grudhrasi (Sciatica): A randomized controlled trial [version 3; peer review: 1 approved, 2 approved with reservations] . F1000Research 2024, 13 :9 ( https://doi.org/10.5256/f1000research.167923.r296928) NOTE: it is important to ensure the information in square brackets after the title is included in this citation. The direct URL for this report is: https://f1000research.com/articles/13-9/v2#referee-response-296928 keyboard_arrow_left Back to all reports Reviewer Report 0 Views copyright © 2024 Bapat V. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. 20 Jun 2024 | for Version 1 Vaibhav Bapat , National Institute of Ayurveda Deemed University, Jaipur, Rajasthan, India 0 Views copyright © 2024 Bapat V. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. format_quote Cite this report speaker_notes Responses (1) Approved With Reservations info_outline Alongside their report, reviewers assign a status to the article: Approved The paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved Fundamental flaws in the paper seriously undermine the findings and conclusions The work done by the authors to construct this protocol is admirable. There is a demand for complete language editing. Please reconsider the title because control trials are referenced in the title but no specifics about the control group are available anywhere. There might be better optional keywords. Aushadh Sevan Kala is not mentioned. Details of the Katibasti procedure with SOP must be included in this protocol. The inclusion and exclusion criteria appear insufficient. The patient's sex is not mentioned, however pregnant and breastfeeding women are noted in the exclusion criteria. Because the protocol is for 30 days, it is vital to mention whether the katibasti procedure will be continued or discontinued during menstruation. The discussion is written as the study has already been conducted; rather, it should be in accordance with the protocol and should explore the possibility of positive and negative consequences. Is the rationale for, and objectives of, the study clearly described? Partly Is the study design appropriate for the research question? Partly Are sufficient details of the methods provided to allow replication by others? No Are the datasets clearly presented in a useable and accessible format? Yes Competing Interests No competing interests were disclosed. Reviewer Expertise Ayurveda, Skin diseases, Musculoskeletal disorders I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above. reply Respond to this report Responses (1) Author Response 28 Jun 2024 Mayank Rai, Datta Meghe Institute of Higher Education & Research, Wardha, India Respected Sir/Ma'am, I have made all the corrections suggested to me by you. I have mentioned control and interventional groups. Katibasti taken as adjuvant therapy in the study only for initial seven days. Katibasti will be continued in menstruating females as per their consent if given priority to disease symptoms. Thanking you, Yours truly, Mayank Rai PG Scholar MGACH&RC, DMIHER,Wardha View more View less Competing Interests No competing interests were disclosed. reply Respond Report a concern Bapat V. Peer Review Report For: Comparative evaluation of efficacy of Trayodashang Guggul versus Rasona Pinda as an adjuvant with Katibasti in the management of Grudhrasi (Sciatica): A randomized controlled trial [version 3; peer review: 1 approved, 2 approved with reservations] . F1000Research 2024, 13 :9 ( https://doi.org/10.5256/f1000research.152851.r281463) NOTE: it is important to ensure the information in square brackets after the title is included in this citation. The direct URL for this report is: https://f1000research.com/articles/13-9/v1#referee-response-281463 keyboard_arrow_left Back to all reports Reviewer Report 0 Views copyright © 2024 Kamath S. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. 11 Jun 2024 | for Version 1 Shrilatha Kamath , Sri Dharmasthala Manjunatheshwara College of Ayurveda, Udupi, Karanataka, India 0 Views copyright © 2024 Kamath S. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. format_quote Cite this report speaker_notes Responses (1) Approved With Reservations info_outline Alongside their report, reviewers assign a status to the article: Approved The paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved Fundamental flaws in the paper seriously undermine the findings and conclusions Review of the article: Comparative evaluation of efficacy of Trayodashang Guggul versus Rasona Pinda as an adjuvant with Katibasti in the management of Grudhrasi (Sciatica): A randomized controlled trial 1. Title itself is ambiguous- Comparative and controlled words are totally different. This study seems like a comparative study as there is no controlled drug specified 2. Allocation method is not mentioned. Type of randomizing method into two groups has to be mentioned (such as simple or permuted block randomization etc.) 3. In methodology, inclusion criteria- Patients having classical signs and symptoms cannot be mentioned. it has to be specific (2-4). Diagnosis can't rely on presence or absence of all the subjective and objective criteria mentioned. 4. In exclusion criteria IVDP is mentioned. But to exclude MRI is compulsory. As no investigations done is mentioned in the article it cannot be considered. Author has to specify whether only Lumbar spondylosis is included. 5. Throughout the study assessment is mentioned on 0,15,45 days. But in the Participant timeline- it is written as: Patients will be treated for 60 days and assessment will be done up to 90 days as mentioned in.... which doesn't match at all. 6. Statistical test: "As the study is randomized controlled trial, both parametric and non parametric tests like independent t-test, paired t-test, and Man-Whitney statistical test will be applied to the data generated": a. This study is neither randomized nor controlled b. Non Parametric test has to be Wilcoxon signed rank test and Mann Whitney along with t test Is the rationale for, and objectives of, the study clearly described? Partly Is the study design appropriate for the research question? Partly Are sufficient details of the methods provided to allow replication by others? Partly Are the datasets clearly presented in a useable and accessible format? Partly References 1. Rai M, Misar S, Gamne R: Comparative evaluation of efficacy of Trayodashang Guggul versus Rasona Pinda as an adjuvant with Katibasti in the management of Grudhrasi (Sciatica): A randomized controlled trial. F1000Research . 2024; 13 . Publisher Full Text Competing Interests No competing interests were disclosed. Reviewer Expertise MedicineKayachikitsa I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above. reply Respond to this report Responses (1) Author Response 28 Jun 2024 Mayank Rai, Datta Meghe Institute of Higher Education & Research, Wardha, India Respected Mam/sir I have made all the necessary corrections suggested by you. I have specified the sampling procedure,inclusion-exclusion criteria, statistical analysis plan, study duration, and rest of corrections. kindly please consider my manuscript for further proceedings. thanking you your's faithfully Mayank Rai PG Scholar MGACH&RC Datta meghe institute of higher education & research center View more View less Competing Interests No competing interests were disclosed. reply Respond Report a concern Kamath S. Peer Review Report For: Comparative evaluation of efficacy of Trayodashang Guggul versus Rasona Pinda as an adjuvant with Katibasti in the management of Grudhrasi (Sciatica): A randomized controlled trial [version 3; peer review: 1 approved, 2 approved with reservations] . F1000Research 2024, 13 :9 ( https://doi.org/10.5256/f1000research.152851.r281465) NOTE: it is important to ensure the information in square brackets after the title is included in this citation. 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