A Clinical study to evaluate efficacy and safety of CaFi Liquid (Cassia Fistula Extract) in the Management of Functional Constipation and Irregular Bowel Habit in Children (Paediatric population) -An Open Labeled, Multi centric, Interventional, Prospective, Clinical Study
Trial Snapshot
- Phase
- Phase 2/3
- Status
- Recruiting
- Sponsor
- Enrollment
- 100
- Locations
- 2
- Primary Endpoint
- Change in frequency of bowel movements and tolerability of study product
Study Overview
Brief Summary
It is a clinical study to evaluate efficacy and safety of CaFi Liquid (Cassia Fistula Extract) in the Management of Functional Constipation and Irregular Bowel Habit in Children (Pediatric population). The study will be conducted at 3 to 4 centers in India. The primary objectives of the study will be to assess change in frequency of bowel movements and tolerability of study product. The secondary objectives of the study will be to assess change in stool form, symptoms of functional constipation, associated clinical symptoms and symptoms of worm infestations, change in digestion and global assessment of overall change on screening Visit (Up to 3 days), Baseline Visit (Day 0), Visit 1 (Day 7), Visit 2 (Day 14), Visit 3 (Day 21
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Masking
- None
Eligibility Criteria
- Ages
- 6.00 Year(s) to 15.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Participants meeting ROME IV Criteria for Functional Constipation
- •Parents who are ready to provide written informed consent for participation of their children and follow the protocol requirements of the clinical study.
Exclusion Criteria
- •Subjects diagnosed with colonic inertia, and recently undergone abdominal surgery including anorectal surgery.
- •2.Subjects having other functional gastrointestinal disorders other than Functional constipation (i.e., IBS, Belching disorders etc.)
- •Subjects diagnosed with any anorectal and intestinal structural abnormalities
- •Subjects with uncontrolled DM, Tuberculosis, neurological problems
- •Known cases of HIV, HCV, HBV, renal or liver dysfunction
- •Subjects allergic or atopic to any of the ingredients of the study medications
- •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.
Outcomes
Primary Outcomes
Change in frequency of bowel movements and tolerability of study product
Time Frame: Screening Visit (Up to 3 days), Baseline Visit (Day 0), Visit 1 (Day 7), Visit 2 (Day 14), Visit 3 (Day 21)
Secondary Outcomes
- 1. Change in stool form, symptoms of functional constipation, associated clinical symptoms and symptoms of worm infestations(2. Change in digestion)
Investigators
Dr Kalpana Dhuri
D Y Patil School of Ayurveda, Mumbai