Efficacy and safety of an Ayurvedic Menohelp syrup in the management of heavy menstrual bleeding (menorrhagia): an open-label clinical study.

Heavy menstrual bleeding (HMB), traditionally referred to as menorrhagia, is a common gynaecological complaint amongst women of reproductive age and significantly affects physical, psychological, social and occupational well-being. 1 Excessive menstrual blood loss may result in anaemia, fatigue, reduced quality of life and impaired daily functioning. In India, a considerable proportion of women experience HMB during their reproductive years, with many remaining untreated because of social stigma, limited awareness or restricted access to healthcare services. 2 According to the International Federation of Gynaecology and Obstetrics (FIGO), abnormal uterine bleeding is classified using the PALM-COEIN system based on structural and non-structural aetiologies. 3 Although abnormal uterine bleeding comprises multiple aetiologies under the FIGO PALM-COEIN classification, the present study specifically evaluated women presenting predominantly with HMB symptoms. Structural causes of HMB include polyp, adenomyosis, leiomyoma (fibroids), malignancy and hyperplasia (PALM), whereas non-structural causes include coagulopathy, ovulatory dysfunction, endometrial disorders, iatrogenic causes and conditions not otherwise classified (COEIN). Management of HMB commonly includes non-steroidal anti-inflammatory drugs, antifibrinolytics, hormonal therapies and levonorgestrel intrauterine systems. However, these treatment approaches may not be suitable for all women because of contraindications, adverse effects, cost, limited long-term tolerability or patient preference for non-hormonal therapies. 4 Consequently, there is increasing interest in complementary and traditional medical systems, including Ayurveda, for the management of menstrual disorders. 5 , 6 In Ayurveda, HMB is described under conditions such as Asrigdara or Raktapradara, which are associated with an imbalance of Pitta dosha and vitiation of Rakta dhatu. Ayurvedic formulations containing medicinal plants with haemostatic, anti-inflammatory and uterine-supportive properties have traditionally been used in the management of excessive uterine bleeding. 7 , 8 Saraca asoca (Ashoka), one of the principal herbs used in Ayurvedic gynaecological practice, has traditionally been recommended for excessive menstrual bleeding and other uterine disorders. 9 – 11 Menohelp Syrup is an Ayurvedic formulation containing Ashoka along with supportive herbal ingredients ( Table 1 ) intended for the management of HMB and associated symptoms. The present study was conducted to evaluate the safety and efficacy of Menohelp Syrup in women with HMB, with emphasis on menstrual blood loss, bleeding-related symptoms and quality-of-life outcomes.

A total of 288 participants were screened for eligibility during the study period. Amongst them, 228 eligible participants were enrolled and received study treatment. Of the enrolled participants, 217 completed the 90-day treatment and follow-up period, whilst 11 participants were lost to follow-up or discontinued participation during the study ( Figure 2 ). At baseline, participants demonstrated a bleeding profile consistent with clinically significant HMB. Mean estimated menstrual blood loss was 123.6±22.4 mL per cycle, occurring over a mean duration of 10.2±2.0 days. The mean PBAC score was 152.8±38.6. Participants reported using 7.6±2.2 sanitary pads or towels per day, with notable nocturnal bleeding. Fully soaked pads during the night occurred at a mean frequency of 1.9±0.9 per night. Additional parameters included a mean clot passage score of 2.9±0.8 and a total of 4.7±1.6 bleeding-related toilet visits per day. Progressive improvement in menstrual bleeding parameters was observed throughout the treatment period, with statistically significant reductions evident from day 30 onwards. Estimated menstrual blood loss decreased significantly from baseline at day 30 ( p =0.014), with further reductions observed at day 60 ( p =0.001) and day 90 ( p <0.001). Similarly, PBAC scores decreased significantly at day 30 ( p =0.019), day 60 ( p =0.001) and day 90 ( p <0.001), whilst bleeding duration was also significantly reduced throughout the treatment period (day 30: p =0.023; day 60: p =0.002; day 90: p <0.001) ( Table 3 ). By the end of treatment, mean estimated menstrual blood loss declined from 123.6±22.4 mL per cycle at baseline to 56.9±17.8 mL per cycle ( Figure 3 ), whilst mean PBAC scores decreased from 152.8±38.6 to 64.7±23.9. Overall, the findings indicated marked improvement in menstrual bleeding severity and associated symptom burden following treatment with Menohelp Syrup ( Figure 4 ). Mean haemoglobin levels improved significantly from baseline to day 90, increasing from 10.64±0.96 g/dL to 11.38±0.88 g/dL ( p =0.043), consistent with the reduction in menstrual blood loss. In contrast, endometrial thickness remained stable throughout the study with no statistically significant change between baseline (7.32±1.54 mm) and day 90 (7.28±1.36 mm; p =0.624) ( Table 4 ). Significant improvement was observed across subjective symptom parameters during treatment. By day 90, most participants reported normalization of bleeding duration and intermenstrual interval, along with a substantial reduction in dysmenorrhoea, lower abdominal pain and low backache severity. Most participants experienced absent or mild symptoms at the end of treatment ( Table 5 ). Health-related quality of life was assessed using the MIQ, evaluating perceived menstrual blood loss, daily functioning, physical activity, social participation and patient-perceived treatment benefit. By the end of treatment, most participants reported improvement in perceived menstrual blood loss along with minimal disruption in work-related, physical, social and leisure activities. Most participants experienced mild or no functional limitation across assessed domains. Additionally, 99.55% of participants considered the reduction in menstrual blood loss to be clinically meaningful and beneficial following treatment with Menohelp Syrup.

The present clinical study evaluated the safety and efficacy of Menohelp Syrup in women with HMB. Treatment with Menohelp Syrup was associated with statistically significant improvement in menstrual bleeding parameters, bleeding-related symptoms and quality-of-life outcomes (all p <0.001 at day 90; Table 3 ) over the 90-day treatment period. Overall findings indicated clinically meaningful reduction in menstrual bleeding severity along with improvement in associated symptom burden and daily functioning. The observed reduction in menstrual blood loss may be attributed to the pharmacological properties of the formulation ingredients. Saraca asoca (Ashoka), the principal component of Menohelp Syrup, has traditionally been used in Ayurvedic gynaecological practice for HMB and is reported to possess haemostatic, astringent, anti-inflammatory and uterine-supportive properties. 9 – 11 These actions may contribute to stabilization of endometrial bleeding and improved menstrual regulation. Additional herbal ingredients ( Table 1 ), such as Symplocos racemosa , Mesua ferrea and Cyperus rotundus may provide complementary anti-inflammatory, analgesic, antispasmodic and haemostatic effects, respectively, thereby contributing to overall symptomatic improvement. 13 , 14 Improvement in dysmenorrhoea, lower abdominal pain and low backache observed during treatment may be related to the anti-inflammatory and antispasmodic properties of the formulation components. Reduction in pain-associated symptoms is clinically relevant because HMB is frequently associated with physical discomfort, impaired daily functioning, and reduced psychosocial well-being. The improvement in haemoglobin levels observed during the study is consistent with a reduction in menstrual blood loss. Improved bleeding control may reduce chronic iron loss and contribute to gradual haematological recovery, whilst supportive management for anaemia, where applicable, may also have contributed. Importantly, endometrial thickness remained stable throughout the treatment period without clinically significant ultrasonographic changes, suggesting that the formulation did not adversely affect endometrial morphology. Quality-of-life assessment using the MIQ demonstrated improvement across domains related to daily activities, physical functioning, work-related performance and social well-being. Most participants perceived the reduction in menstrual blood loss as clinically meaningful, reflecting good patient acceptability and perceived therapeutic benefit. The findings of the present study suggest that Menohelp Syrup may serve as a safe and potentially beneficial non-hormonal therapeutic option for women with HMB, particularly for individuals seeking complementary or Ayurvedic approaches for symptom management. The favourable tolerability profile observed during the study further supports its potential clinical utility. Strengths of the present study include the prospective clinical design, relatively large sample size, standardized PBAC-based assessment and comprehensive evaluation of bleeding-related symptoms and quality-of-life outcomes over multiple follow-up visits. However, the study also had certain limitations, including the single-arm open-label study design, absence of a comparator group, and lack of long-term follow-up. In addition, menstrual blood loss assessment relied partly on participant-reported PBAC recordings, which may introduce subjective reporting variability despite the use of standardized PBAC-based menstrual pictograms and participant training. Larger randomized controlled studies with extended follow-up are required to further establish the efficacy, safety and long-term clinical benefits of Menohelp Syrup in women with HMB.

Menohelp Syrup demonstrated clinically meaningful improvement in HMB, associated bleeding-related symptoms and quality-of-life outcomes in women of reproductive age. The formulation was well tolerated and showed a favourable safety profile without clinically significant endometrial changes during treatment. These findings suggest that Menohelp Syrup may represent a safe and potentially beneficial non-hormonal therapeutic option for the management of HMB, particularly in women seeking complementary or Ayurvedic approaches for symptom management. Further randomized controlled studies with larger sample sizes and longer follow-up are warranted to confirm these findings and establish long-term clinical benefits. The findings of this study suggest that Menohelp Syrup may serve as a practical non-hormonal therapeutic option for women with HMB, particularly for individuals seeking complementary or Ayurvedic management approaches. Its favourable tolerability and potential to improve bleeding-related symptoms and quality of life may support its use in routine clinical practice.

The study was conducted between March 2022 and April 2024 at the Department of Prasuti Tantra and Stree Roga, All India Institute of Ayurveda (AIIA), New Delhi, India, a national apex institute under the Ministry of AYUSH, Government of India. This was a prospective, open-label, single-arm clinical trial evaluating the safety and efficacy of Menohelp Syrup in women with HMB. The study protocol was approved by the Institutional Ethics Committee of AIIA, New Delhi, on 26 July 2021 (IEC Approval No: AIIA/2021-P75) and registered with the Clinical Trials Registry of India (CTRI/2021/12/038921). The study was conducted in accordance with the Declaration of Helsinki and Good Clinical Practice guidelines. A single-arm exploratory design was selected to evaluate the preliminary safety, tolerability and clinical efficacy of the formulation prior to conducting larger randomized controlled studies. Participants were recruited from the outpatient department of Prasuti Tantra and Stree Roga at AIIA, New Delhi, based on clinical presentation suggestive of heavy, prolonged or irregular menstrual bleeding. Written informed consent was obtained before enrolment, and clinical data were recorded using a structured case record form. Eligible participants were identified based on a clinical diagnosis of HMB. HMB was identified based on estimated menstrual blood loss derived from pictogram-based assessment, with menstrual blood loss ≥80 mL per cycle considered indicative of HMB. Women were included if aged 18–45 years with HMB characterized by one or more of the following: excessive menstrual bleeding (estimated blood loss ≥80 mL per cycle); prolonged menstrual bleeding (>7 days per menstrual cycle); intermenstrual bleeding; and frequent menstrual cycles (cycle interval <21 days). Participants were required to have a normal gynaecological examination and a normal Pap smear. Participants were excluded if they had any of the following: organic uterine pathology (adenomyosis, tubo-ovarian mass, sub-mucosal or intramural fibroids, or sub-cervical fibroids >3 cm); systemic disorders such as hypertension, diabetes mellitus, congestive cardiac failure, coagulopathy, liver or thyroid dysfunction; malignancy or suspected neoplastic conditions; active genital tuberculosis; bleeding due to cervical polyps or erosion; intrauterine contraceptive device in situ; postmenopausal bleeding, pubertal menorrhagia or pelvic endometriosis; haemoglobin level <8 g/dL; pregnancy or lactation; or history of recent abortion or chronic constipation. All participants underwent detailed gynaecological evaluation prior to enrolment, including clinical examination, Pap smear and pelvic ultrasonography, to exclude structural uterine abnormalities, endometrial pathology, cervical lesions and suspected malignancy. Participants with findings suggestive of significant organic pathology were excluded from the study. Menstrual blood loss was assessed using a Pictorial Blood Assessment Chart (PBAC)-based menstrual pictogram as prespecified in the study protocol and based on the method described by Higham et al. 12 Participants were trained to maintain a daily pre-printed menstrual diary during each menstrual cycle, documenting the following: number of sanitary pads or towels used; degree of saturation of sanitary towels; passage of clots (small and large); and episodes of flooding or urgency. All participants used standardized superabsorbent polymer (SAP)-based sanitary towels to maintain consistency in menstrual blood loss assessment. PBAC recordings were mapped to pictogram categories corresponding to estimated menstrual blood loss volumes (mL), enabling semi-quantitative assessment of bleeding severity. A PBAC score of >100 was considered indicative of HMB, corresponding to menstrual blood loss of ≥80 mL per cycle. PBAC assessment was completed by participants using pre-printed menstrual diaries and reviewed by study investigators during follow-up visits. The pictogram evaluated stain distribution corresponding to the absorption characteristics of SAP sanitary products, enabling standardized assessment of menstrual blood loss throughout the study period. A total of 228 participants were enrolled in the study. The sample size was calculated based on a confidence interval level of 95% and a margin of error of 7%. The sample size for this study was calculated using the following formula for estimating a proportion in a population: Where n is the required sample size, Z is the confidence level (1.96 for 95%), p is the assumed population proportion (0.5, i.e. 50%), and e is the margin of error (0.07 or 7%). Based on the expected clinical improvement in women with HMB and considering feasibility during the study period, the calculated sample size was considered adequate for evaluation of safety and efficacy outcomes. Additional allowance was considered for possible participant dropouts and incomplete follow-up. Participants received Menohelp Syrup orally at a dose of 15 mL twice daily (morning and evening) after meals for duration of 90 days. A standardized measuring cup was provided, and participants were instructed to maintain consistent dosing times to ensure adherence. The study consisted of a screening visit, a baseline visit (day 0), and three scheduled follow-up visits during the 90-day treatment period. At each visit, predefined efficacy and safety assessments, laboratory investigations, and patient-reported outcome measures were performed according to the study protocol. The schedule of study visits and the assessments conducted at each visit are summarized in Table 2 . The primary outcomes were a reduction in menstrual blood loss assessed using the PBAC on days 30, 60 and 90 as well as changes in bleeding duration, menstrual cycle interval, menstrual blood loss volume and quality-of-life outcomes assessed using the Menorrhagia Impact Questionnaire (MIQ). The secondary outcomes were assessment of safety, dysmenorrhoea, lower abdominal pain, low backache, haemoglobin levels, endometrial thickness and patient-reported global therapeutic response categorized as excellent, good, fair or poor. Participant safety was monitored throughout the study. Participants were withdrawn if any of the following occurred: development of severe or unrelated illness, worsening of symptoms (approximately 50% increase from baseline) or failure to attend three consecutive follow-up visits. Rescue medication was administered when clinically necessary. Any adverse events occurring during the intervention were managed with appropriate pharmacological treatment prescribed by qualified medical practitioners, or with additional Ayurvedic medication when required. All adverse events were documented, including the nature of the reaction, treatment provided and clinical outcome. Clinical symptoms were assessed using a predefined grading system based on severity. The following parameters were evaluated ( Figure 1 ): Duration of bleeding: Grade 0 (≤5 days); Grade 1 (5–7 days); Grade 2 (8–10 days); Grade 3 (>10 days). Intermenstrual period: Grade 0 (26–30 days); Grade 1 (21–25 days); Grade 2 (16–20 days); Grade 3 (<15 days or irregular). Amount of blood loss: assessed using PBAC-based menstrual pictogram. Lower abdominal pain (Udarashula) and low backache (Katishula): assessed using a visual analogue scale (VAS; 0–10), graded as mild (1–3), moderate (4–7), or severe (8–10). Overall therapeutic response was categorized as follows: no improvement (<25% symptom reduction), mild improvement (26–50%), moderate improvement (51–75%), marked improvement (76–99%) and complete remission (100%). Endometrial thickness was assessed using transvaginal ultrasonography (USG pelvis) at baseline and at the end of treatment. Ultrasonographic evaluation was performed during the early proliferative phase of the menstrual cycle (days 5–7) to minimize physiological variation in endometrial thickness measurements. Statistical analysis was performed using SPSS software. Both intention-to-treat and per-protocol analyses were conducted. Descriptive statistics were expressed as mean, standard deviation and standard error. Comparisons between baseline and follow-up visit values were analysed using paired Student’s t -test where appropriate, with p <0.05 considered statistically significant.