Clinical study of Softovac Liquifibre in constipation

Phase 2/3

Completed

Conditions: Constipation. Ayurveda Condition: VIBANDHA,

Registration Number: CTRI/2023/03/051094

Lead Sponsor: Lupin Limited

Brief Summary: It is an open label, randomized, comparative, multi centric, interventional, prospective, clinical study to evaluate efficacy and safety of Softovac Liquifibre in the management of functional constipation and Irregular Bowel Habit. The study will be carried out in two cohort. Cohort 1 will have adult population and cohort 2 will have children and teenagers. The study will be carried out at three to four centers in India. In cohort 1, subjects will be randomized to either Softovac Liquifibre group or milk of magnesia + Liquid paraffin group. Subjects in Softovac Liquifibre group will be given 20 ml Softovac Liquifibre at bedtime with water for 14 days and subjects in milk of magnesia + Liquid paraffin group will be given 10 ml of milk of magnesia + Liquid paraffin at bedtime with water for 14 days. All the subjects will be asked to stop given medication after 14 days and will be followed for next seven days to observe recurrence of symptoms of functional constipation and irregular bowel habit. In cohort 2, subjects will be given 5 to 10 ml Softovac Liquifibre at bedtime with water for 14 days. All the subjects will be asked to stop given medication after 14 days and will be followed for next seven days to observe recurrence of symptoms of functional constipation and irregular bowel habit. Primary objective of cohort 1 and 2 will be to assess change in frequency of bowel movements. Secondary objectives of cohort 1 and 2 will be to assess change in stool form, changes in symptoms of functional constipation including straining on defecation, sensation of incomplete evacuation, sensation of ano-rectal blockage, manual maneuvers required & average time spent for bowel evacuation, changes in associated clinical symptoms including headache, belching, flatulence, abdominal distension/bloating, acidity, average duration of action (from the time of consuming tablets to first bowel movement), global assessment of overall change as per the investigator and subject, assessment of tolerability of study products as per the investigator and subject. Additionally in cohort 1, assessment of laboratory investigations such as CBC, ESR, Hb%, Blood sugar fasting, Liver profile and Renal Profile will be done.

Summary of Results:

It can be concluded from the results of the study that Softovac Liquifibre was significantly effective in increasing frequency of bowel movements in adults and children suffering from functional constipation and irregular bowel habit. Softovac Liquifibre was significantly effective in softening stool, reliving straining on defecation, sensation of anorectal blockage and requirement of manual maneuvers in children and adults. Time spent for defecation was significantly reduced after usage of Softovac Liquifibre in adults and children. Symptoms associated with constipation, viz. headache, acidity, belching, flatulence, and abdominal bloating/distension significantly improved after usage of Softovac Liquifibre in adults and children. Symptoms and associated symptoms of functional constipation did not recur on day 21 after stoppage of treatment from day 14 onwards both in adults as well as in children suggesting non-habit-forming nature of Softovac Liquifibre. The results of the study also showed all parameters comparable (non significantly different) with current market leading formulation for functional constipation. Softovac Liquifibre can be recommended as a safe and effective remedy for functional constipation and irregular bowel habit in adults and children.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 108

Inclusion Criteria

Male or female subjects between the age group of 18 to 70 years (Cohort 1) and 6 to 15 years (Cohort 2) Subjects diagnosed as per the Rome IV diagnostic criteria for Functional constipation, 2016 (Cohort 1) and ROME IV Criteria for Functional Constipation (H3a) (Cohort 2) 3.
Subjects who are ready to provide written informed consent and who are ready to willingly participate and follow the protocol requirements of the clinical study.

Exclusion Criteria

Subjects diagnosed with colonic inertia.
Subjects who have recently undergone abdominal surgery 3.
Subjects with history of anorectal surgery.
4.Subjects having other functional gastrointestinal disorders other than Functional constipation (i.e., IBS, Belching disorders etc.) 5.
Subjects diagnosed with structural abnormalities of intestine 6.
Known cases of HIV, tuberculosis, hypo and hyperthyroidism 8.
Known cases of renal or liver dysfunction.
Subjects diagnosed with neurological problems 10.
Subjects on chronic medication (>60 days) and/or who are on medications known to cause constipation.
Subjects allergic or atopic to any of the ingredients of the study medications 13.
Other conditions, which in the opinion of the investigators makes the patient unsuitable for enrolment or could interfere in adherence to of the study protocol.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cohort 1 and 2:	Screening visit, Day 0, Day 7, Day 14 and Day 21
Change in frequency of bowel movements from baseline visit to the end of the study visit and between the two groups	Screening visit, Day 0, Day 7, Day 14 and Day 21

Secondary Outcome Measures

Name	Time	Method
Cohort 1 and 2:	1. Change in stool form

Trial Locations

Locations (3): Ayurved Seva Sanghâ€™s Ayurved Mahavidyalaya
🇮🇳
Nashik, MAHARASHTRA, India
KVTR Ayurvedic College and Hospital Boradi
🇮🇳
Dhule, MAHARASHTRA, India
R. A. Podar Medical, College (Ayu), M. A. Podar Hospital
🇮🇳
Mumbai, MAHARASHTRA, India
Ayurved Seva Sanghâ€™s Ayurved Mahavidyalaya
🇮🇳Nashik, MAHARASHTRA, India
Dr Shishir Pande
Principal investigator
9146030818
shishir.nsk@gmail.com