Clinical study for Evaluation of Efficacy and Safety of Softovac Liquifibre in the Management of Functional Constipation and Irregular Bowel Habits in Adults and Children

Clinical study for Evaluation of Efficacy and Safety of Softovac Liquifibre in the Management of Functional Constipation and Irregular Bowel Habits in Adults and Children | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Clinical study for Evaluation of Efficacy and Safety of Softovac Liquifibre in the Management of Functional Constipation and Irregular Bowel Habits in Adults and Children Dr. Umesh Mishra, Dr. Narendra Mundhe, Dr. Shishir Pande, Dr. Pradyna Kapse, and 2 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-5059934/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version Abstract Background and objectives: Constipation is a common bowel dysfunction characterized by infrequent bowel movements. Though modern medical management are well established & safe, they may be habit forming, have potential few side effects & may not provide satisfying relief. The objective of this study was to the evaluate efficacy & safety of an Ayurvedic formulation Softovac Liquifiber in the management of Functional constipation & irregular bowel habits in adults and children. Materials and methods: The study was conducted in two cohorts, adults and children. The adult cohort comprised of two arms randomly allotted to either Softovac Liquifiber or control group (marketed liquid laxative preparation). A total of 64 participants completed the study in this cohort, 33 participants in Softovac Liquifiber group and 31 participants in the control group. Children cohort was a single arm non-comparative study with a total of 32 participants. Adult participants were asked to consume Softovac Liquifiber in a dose of 20 ml at bedtime while in the children cohort the dose was 5-10 ml at bedtime. The total duration of study product consumption was 14 days after which participants were followed further for 7 days without taking the study products. Evaluation of efficacy was done by assessing the frequency of bowel movements, consistency of stool on Bristol scale along with other symptoms associated with constipation. Results: A statistically significant improvement was observed in the frequency of bowel movement, softening of stool, reduction in straining on defecation & sensation of anorectal blockage and requirement of manual maneuvers with the use of Softovac Liquifibre. Results in the adult cohort were comparable between the two groups (non significant difference). Significant improvement in frequency and softening of stool was observed in children along with reduction in symptoms of constipation. No adverse effects were observed and no significant changes were observed in laboratory related safety parameters. Conclusion: The study concludes that Softovac Liquifibre was significantly effective in increasing frequency of bowel movements, softening of stool, reducing straining on defecation, sensation of anorectal blockage and requirement of manual maneuvers in adults and children suffering from functional constipation and irregular bowel habit. Symptoms of functional constipation did not recur after stoppage of Softovac Liquifiber both in adults as well as in children suggesting non-habit-forming nature of Softovac Liquifibre. Integrative & Complementary Medicine Constipation Softovac Liquifiber Full Text Additional Declarations The authors declare no competing interests. Cite Share Download PDF Status: Posted Version 1 posted You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-5059934","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":351689894,"identity":"27d65035-57a3-4791-b9ae-0154fbbfc056","order_by":0,"name":"Dr. Umesh Mishra","email":"","orcid":"","institution":"Lupin Ltd","correspondingAuthor":false,"prefix":"Dr.","firstName":"Umesh","middleName":"","lastName":"Mishra","suffix":""},{"id":351689895,"identity":"87f021ff-ba9c-4da3-a7b7-70a1f4891f0a","order_by":1,"name":"Dr. Narendra Mundhe","email":"","orcid":"","institution":"KVTR Ayurvedic College \u0026 Hospital, Boradi, Shirpur Maharashtra, 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Though modern medical management are well established \u0026amp; safe, they may be habit forming, have potential few side effects \u0026amp; may not provide satisfying relief. The objective of this study was to the evaluate efficacy \u0026amp; safety of an Ayurvedic formulation Softovac Liquifiber in the management of Functional constipation \u0026amp; irregular bowel habits in adults and children.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMaterials and methods:\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe study was conducted in two cohorts, adults and children. The adult cohort comprised of two arms randomly allotted to either Softovac Liquifiber or control group (marketed liquid laxative preparation). A total of 64 participants completed the study in this cohort, 33 participants in Softovac Liquifiber group and 31 participants in the control group. Children cohort was a single arm non-comparative study with a total of 32 participants. Adult participants were asked to consume Softovac Liquifiber in a dose of 20 ml at bedtime while in the children cohort the dose was 5-10 ml at bedtime. The total duration of study product consumption was 14 days after which participants were followed further for 7 days without taking the study products. Evaluation of efficacy was done by assessing the frequency of bowel movements, consistency of stool on Bristol scale along with other symptoms associated with constipation.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eResults:\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eA statistically significant improvement was observed in the frequency of bowel movement, softening of stool, reduction in straining on defecation \u0026amp; sensation of anorectal blockage and requirement of manual maneuvers with the use of Softovac Liquifibre. Results in the adult cohort were comparable between the two groups (non significant difference). Significant improvement in frequency and softening of stool was observed in children along with reduction in symptoms of constipation. \u0026nbsp;No adverse effects were observed and no significant changes were observed in laboratory related safety parameters.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConclusion:\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe study concludes that Softovac Liquifibre was significantly effective in increasing frequency of bowel movements, softening of stool, reducing straining on defecation, sensation of anorectal blockage and requirement of manual maneuvers in adults and children suffering from functional constipation and irregular bowel habit. 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