| CTRI Number |
CTRI/2025/08/092637 [Registered on: 08/08/2025] Trial Registered Prospectively |
| Last Modified On: |
07/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Clinical study on CaFi Liquid in Irregular Bowel Habit in Children |
|
Scientific Title of Study
|
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 Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| TIMER/CAFI-F/FCP/2025/1, Version 1.0, 04th May 2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kalpana Dhuri |
| Designation |
Professor |
| Affiliation |
D Y Patil School of Ayurveda, Mumbai |
| Address |
Department of Paediatrics,
OPD. No. 5, 2nd Floor, D Y Patil School of Ayurveda, Mumbai
Sector 7, Nerul, Navi Mumbai, Maharashtra 400706
Mumbai (Suburban)
MAHARASHTRA
400706
India |
| Phone |
9321835616 |
| Fax |
|
| Email |
kalpana.dhuri@dypatil.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjay Tamoli |
| Designation |
Director |
| Affiliation |
Target Institute of Medical Education and Research Pvt. Ltd |
| Address |
Target Institute of Medical Education and Research Pvt. Ltd
A wing 402 A/B/C, Jaswanti Allied Business Center,
Ramchandra Lane Extension,
Kachpada, Malad West, Mumbai 400064
Mumbai (Suburban)
MAHARASHTRA
400064
India |
| Phone |
9322522252 |
| Fax |
|
| Email |
targetinstitute@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanjay Tamoli |
| Designation |
Director |
| Affiliation |
Target Institute of Medical Education and Research Pvt. Ltd |
| Address |
Target Institute of Medical Education and Research Pvt. Ltd
A wing 402 A/B/C, Jaswanti Allied Business Center,
Ramchandra Lane Extension,
Kachpada, Malad West, Mumbai 400064
MAHARASHTRA
400064
India |
| Phone |
9322522252 |
| Fax |
|
| Email |
targetinstitute@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Target Institute of Medical Education and Research Pvt. Ltd
A wing 402 A/B/C, Jaswanti Allied Business Center,
Ramchandra Lane Extension,
Kachpada, Malad West, Mumbai 400064
|
|
|
Primary Sponsor
|
| Name |
Target Institute of Medical Education and Research Pvt. Ltd |
| Address |
A wing 402 A/B/C, Jaswanti Allied Business Center,
Ramchandra Lane Extension,
Kachpada, Malad West, Mumbai 400064
|
| Type of Sponsor |
Contract research organization |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Kalpana Dhuri |
D Y Patil School of Ayurveda, Mumbai |
Department of Paediatrics, OPD. No. 5, 2nd Floor
D Y Patil School of Ayurveda, Mumbai
Sector 7, Nerul, Navi Mumbai, Maharashtra 400706
Mumbai (Suburban)
MAHARASHTRA |
9321835616
kalpana.dhuri@dypatil.edu |
| Dr Shailaja U |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital |
Department Kaumarabhritya,
OPD No. 16, Ground floor
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan-573201, Karnataka, India
Hassan
KARNATAKA |
9448816433
rao.shaila@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee D.Y. Patil Deemed to School of Ayurveda, Nerul, Navi Mumbai |
Submittted/Under Review |
| Institutional Ethics Committee Sri Dharmasthala Manjunatheshwara College of Ayurveda & Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Functional Constipation and Irregular Bowel Habit in Children |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
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 for next seven days to observe recurrence of symptoms of functional constipation. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
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.
|
|
| ExclusionCriteria |
| Details |
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.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in frequency of bowel movements and tolerability of study product |
Screening Visit (Up to 3 days), Baseline Visit (Day 0), Visit 1 (Day 7), Visit 2 (Day 14), Visit 3 (Day 21) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
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
|
Screening Visit (Up to 3 days), Baseline Visit (Day 0), Visit 1 (Day 7), Visit 2 (Day 14), Visit 3 (Day 21) |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
18/08/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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 |