A Clinical study on CaFi Liquid in Irregular Bowel Habit in Children

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 - NIL

Status

Recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/08/092637

Enrollment

100

Registered

2025-08-08

Start date

Unknown

Completion date

Unknown

Last updated

2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: CaFi Liquid: Subjects will be given 5 ml of CaFi Liquid at bedtime with water for 14 days. All the subjects will be asked to stop given medication after 14 days and will be followed f

Eligibility

Inclusion criteria

Inclusion criteria: 1. Participants meeting ROME IV Criteria for Functional Constipation 2. 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

Exclusion criteria: 1. 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.) 3. Subjects diagnosed with any anorectal and intestinal structural abnormalities 4. Subjects with uncontrolled DM, Tuberculosis, neurological problems 5. Known cases of HIV, HCV, HBV, renal or liver dysfunction 6. Subjects on chronic medication (greater than 60 days) and/or who are on medications known to cause constipation. 7. Subjects allergic or atopic to any of the ingredients of the study medications 8. 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.

Design outcomes

Primary

Measure	Time frame
Change in frequency of bowel movements and tolerability of study productTimepoint: Screening Visit (Up to 3 days), Baseline Visit (Day 0), Visit 1 (Day 7), Visit 2 (Day 14), Visit 3 (Day 21)	—

Secondary

Measure	Time frame
1. Change in stool form, symptoms of functional constipation, associated clinical symptoms and symptoms of worm infestations 2. Change in digestion 3. Global assessment of overall change Timepoint: Screening Visit (Up to 3 days), Baseline Visit (Day 0), Visit 1 (Day 7), Visit 2 (Day 14), Visit 3 (Day 21)	—

Countries

India

Contacts

Public ContactDr Sanjay Tamoli

Target Institute of Medical Education and Research Pvt. Ltd

targetinstitute@yahoo.com9322522252

Outcome results