| CTRI Number |
CTRI/2026/03/105404 [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 Cold Relief Roll-on |
|
Scientific Title of Study
|
Safety, Tolerability and Efficacy Evaluation of Cold Relief Roll-on in Improving Symptoms of Cold in Infants and Young Children |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| LCBS-MS-187 Version 1.0, dated 07 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 |
Clinical Research Department, 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, MythriLegacy, 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, MythriLegacy, 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 - 1, Panckula, Haryana - 134113, India |
|
|
Primary Sponsor
|
| Name |
Mother Sparsh Baby Care Pvt. Ltd. |
| Address |
Plot #. 330, Industrial Area Phase - 1, Panchkula, Haryana-134113 India |
| Type of Sponsor |
Other [] |
|
|
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 |
Clinical Research Department, 5th Floor,BGS Global Institute of Medical Sciences No. 67 BGS Health & Education City 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:J00||Acute nasopharyngitis [common cold]. Ayurveda Condition: PRATISYAYAH/PINASAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Cold relief roll-on, Reference: NA, Route: Topical, Dosage Form: Dravaka, Dose: 2(NA), Frequency: tds, Bhaishajya Kal: Muhurmuhu, Duration: 10 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
3.00 Month(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects between the ages 3 months to 12 years of either sex. 2. Subjects with acute cold symptoms with nasal and/or chest congestion present for less than or equal to 48 hours. 3. Subjects with at least mild-moderate nasal or chest congestion. 4. Mothers or guardians who agrees to participate their child in this trial and signs a written consent form before the test begins.
|
|
| ExclusionCriteria |
| Details |
1. Subject with severe systemic illness, fever unstable chronic conditions, immunodeficiency, birth defects, anomalies, or other serious comorbidities that could interfere with study participation or safety. 2. Subjects with known allergy or hypersensitivity to any ingredient in the study product, or a history of asthma triggered by topical aromatic products. 3. Subjects with skin conditions at application site, open wounds, eczema flare, rash, burns, or infection that may interfere with topical application or assessments. 4. Subjects using prohibited medications (topical or systemic decongestants, corticosteroids, antihistamines, or other cold medications) within 24-48 hours prior to enrolment. or those judged by the investigator to be inappropriate for participation in the trial. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean change in the severity scores for cold clinical symptoms. |
Day 1, Day 4, Day 8, Day 10 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mean change in the cough severity by parent-reported cough or congestion diary. |
Day 1, Day 4, Day 8, Day 10 |
| Mean change in the sleep quality score by parent-reported outcomes. |
Day 1, Day 4, Day 8, Day 10 |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 with cold. Subjects with acute cold symptoms with nasal and/or chest congestion for less than or equal to 48hrs will be enrolled in the study. Post baseline assessment, product will be applied on the clothes and skin and tracked for change in symptom severity at specified timepoints upto a maximum of 10 days for each subject. |