| CTRI Number |
CTRI/2026/04/107548 [Registered on: 02/04/2026] Trial Registered Prospectively |
| Last Modified On: |
01/04/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Clinical Study of Baby Oils in Healthy Babies and Children. |
|
Scientific Title of Study
|
Safety and Tolerability Evaluation of Baby Oils in Healthy Babies and Children. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| LCBS-MS-183 Version 1.0, Dated 24 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 |
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 Main Road 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 Main Road Kalyan Nagar
Bangalore
KARNATAKA
560043
India |
| Phone |
9845125293 |
| Fax |
|
| Email |
jestin.leadsclinbio@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mother Sparsh Baby Care Pvt. Ltd.,Plot 330, Industrial Area Phase-1, Panchkula, 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 [Manufacturer of natural plant based Food ingredients and Nutraceutical ingredients] |
|
|
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 No 3 Research Department 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 BGS Global Institute of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Normal Biochemical and Hematological Parameters |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | aBya~ggaH, अभ्यंग | (Procedure Reference: , Procedure details: Topical Oil application)
|
|
|
|
Inclusion Criteria
|
| Age From |
0.00 Month(s) |
| Age To |
36.00 Month(s) |
| Gender |
Both |
| Details |
1. Subjects in good health as determined from a recent medical history and physical examination. 2. Subjects whose parent/legal representative, preferably the mother, is willing to provide voluntary written parental informed consent and agrees to abide by, comply with the study protocol, and attend regular follow-up visits. 3. Subjects should not participate in any other clinical study during participation in the current study. |
|
| ExclusionCriteria |
| Details |
1. Subjects above 36 months of age. 2. Subjects with known history or current allergic conditions requiring medical attention, or chronic illnesses that may influence the cutaneous assessment. 3. Subject’s mother/legal representative not willing to stop the use of other lotions/oils during the study period. 4. Subjects on any systemic medication or with birth defects and chromosomal or metabolic anomalies. 5. Subjects participating in a similar clinical study currently or within the previous 30 days. 6. Subjects with medical history (past or present) of significant dermatological diseases or conditions, such as atopy, psoriasis, vitiligo or other conditions known to alter skin appearance or physiological response (porphyria), chronic urticaria, or sunburn, rashes. 7. Subjects judged by the investigator to be inappropriate for this trial. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean change in the scores for overall scalp and hair condition, overall skin condition following the use of the test products, and mean change in the scores of the safety and tolerability scales of the test product. |
Baseline, Day 8 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mean change in the scores for assessment of babys quality of life on using the baby oils by investigators assessment. |
Baseline, Day 8 |
| Mean change in babys sleep onset time, sleep duration and number of awakenings / sleep interruptions on using the baby oils with parent recorded subject diary. |
Baseline, Day 8 |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
13/04/2026 |
| 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="3"
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 to evaluate the safety, tolerability, and effectiveness of test products in improving scalp, hair, and overall skin condition in infants. Subjects aged 0-36 months who meet the eligibility criteria will be enrolled after obtaining written informed consent from their parent or legal guardian. Demographic details and medical history will be collected at baseline. Eligible subjects will be randomized into two groups, with 35 subjects randomized per group. Parents or legal guardians will apply the assigned products daily for 7 consecutive days and will be instructed not to use any other oils, lotions, moisturizers, or home remedies during the study period. Assessments will include parental and investigator evaluation of overall scalp and hair condition, overall skin condition, safety and tolerability, and the baby’s quality of life. Follow-up assessments will be conducted on Day 8, and feedback on overall product performance will be obtained at the end of the study. The total clinical study duration will be up to 8 days per group. |