| CTRI Number |
CTRI/2026/03/105403 [Registered on: 05/03/2026] Trial Registered Prospectively |
| Last Modified On: |
03/03/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Safety, Tolerability and Efficacy Evaluation of Colic Relief Stomach Roll-on |
|
Scientific Title of Study
|
Safety, Tolerability and Efficacy Evaluation of Colic Relief Stomach Roll-on in Improving/Reliving Symptoms of Colic, Indigestion and Constipation in Newborns and Infants |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| LCBS-MS-185 Version 1.0, dated 09 February 2026 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Namana |
| Designation |
Consultant- Ayurvedic Physician |
| Affiliation |
BGS Global Institute of Medical Sciences |
| Address |
Department of Clinical Reseach, 5th Floor, BGS Global Institute of Medical Sciences
No.67, BGS Health & Education City, Uttarahalli Road, Kengeri,
Bangalore
KARNATAKA
560060
India |
| Phone |
8921219255 |
| Fax |
|
| Email |
drnamanah.research@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Jestin V Thomas |
| Designation |
Managing Director and CEO |
| Affiliation |
Leads Clinical Research and Bio Services Pvt. Ltd. |
| Address |
Department of Clinical Research, No.9, 1st Floor, Mythri Legacy, Chelekere MainRoad, Kalyan Nagar
Bangalore
KARNATAKA
560043
India |
| Phone |
9845125293 |
| Fax |
|
| Email |
jestin.leadsclinbio@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Jestin V Thomas |
| Designation |
Managing Director and CEO |
| Affiliation |
Leads Clinical Research and Bio Services Pvt. Ltd. |
| Address |
Department of Clinical Research, No.9, 1st Floor, Mythri Legacy, Chelekere MainRoad, Kalyan Nagar
KARNATAKA
560043
India |
| Phone |
9845125293 |
| Fax |
|
| Email |
jestin.leadsclinbio@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mother Sparsh Baby Care Pvt. Ltd.
Plot No.330, Industrial Area Phase - I, Panchkula, Haryana - 134113, India |
|
|
Primary Sponsor
|
| Name |
Mother Sparsh Baby Care Pvt Ltd |
| Address |
Plot No.330, Industrial Area Phase - I, Panchkula, Haryana - 134113, India |
| Type of Sponsor |
Other [Manufacturer of Baby care and Natural products] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Namana |
BGS Global Institute of Medical Sciences |
OPD number 04 BGS Global Institute of Medical Sciences No 67 BGS Health and Education Uttarahalli Road Kengeri
Bangalore
KARNATAKA |
8921219255
drnamanah.research@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:R681||Nonspecific symptoms peculiar to infancy. Ayurveda Condition: UDARA/UDARAROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Colic relief stomach roll-on, Reference: NA, Route: Topical, Dosage Form: Dravaka, Dose: 1(NA), Frequency: sos, Bhaishajya Kal: Muhurmuhu, Duration: 3 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
7.00 Day(s) |
| Age To |
1.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects between the age group of 1st week to 1 year (of both genders). 2. Recurrent and prolonged periods of crying, fussing, or irritability reported by caregivers associated with colic discomfort as per parental judgement. 3. Subjects with specific FLACC score. 4. Subjects with specific IGSQ score. 5. Parents or guardians willing to let their new born or infants participate in this trial and sign a written consent form before the trial begins.
|
|
| ExclusionCriteria |
| Details |
1. Subjects above 1 year of age. 2. Subjects with chronic colic discomfort, abdominal colic necessitating emergency intervention, excretory system disorders, known congenital or metabolic anomalies or any chronic illness, allergies necessitating medications which can impact the study or subject judged by the investigator to be inappropriate for this trial. 3. Subjects receiving formula for specific medical purposes. 4. Subjects not willing to stop the use of other tummy oil or any medication for this indication during study period. 5. Subjects whose parents or guardians hesitant to sign the informed consent form or abiding by the study protocol. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean change in the discomfort intensity, indigestion, constipation/loose stools, episodes of colic in a day and crying duration. |
Baseline, 30 minutes, 1 hour, 3 hours, 24 hours, Day 3 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mean change in the discomfort irritation/reactions as per investigator’s assessment of parent’s observations. |
Baseline, 30 minutes, 1 hours, 3 hours, 24 hours, Day 3 |
| Mean change in episodes of sleep interruption in 24 hrs as per investigator’s assessment of parent’s observations. |
Baseline, 30 minutes, 1 hours, 3 hours, 24 hours, Day 3 |
| Mean change in duration for expelling gas/stool as per investigator’s assessment of parent’s observations. |
Baseline, 30 minutes, 1 hours, 3 hours, 24 hours, Day 3 |
| Mean change in quality of life as per investigator’s assessment of parent’s observations. |
Baseline, 30 minutes, 1 hours, 3 hours, 24 hours, Day 3 |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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
|
N/A |
|
Date of First Enrollment (India)
|
16/03/2026 |
| 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="1"
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
|
This study aims at evaluating the safety, tolerability and efficacy of the test product in relieving the symptoms and discomforts associated colic, indigestion and constipation. Subjects with recurrent and prolonged periods of crying, fussing, or irritability reported by caregivers associated with colic discomfort as per parental judgement will be enrolled in the study. Post baseline assessment, product will be applied on the stomach around the naval region and tracked for change in symptom severity at specified timepoints upto a maximum of 3 days for each subject. |