CTRI/2021/10/037555 [Registered on: 25/10/2021] Trial Registered Prospectively
Last Modified On:
24/04/2023
Post Graduate Thesis
No
Type of Trial
PMS
Type of Study
Other (Specify) [Cosmeceutical]
Study Design
Single Arm Study
Public Title of Study
To evaluate the safety and efficacy of nourishing baby in 0-36 months babies
Scientific Title of Study
PMOS to evaluate the safety and efficacy of nourishing baby soap in 0-36 months babies
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
HDC/MSCD/CPD/033/2021 Version 01 Dated 7 Jun 2021
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Mohit Poddar
Designation
Consultant
Affiliation
Poddar Hospital
Address
3510AB, Langar Ke Balaji Ka Rasta, Gangori Bazar, Near Neemdi Police Station, Jaipur 302001, Rajasthan
Jaipur RAJASTHAN 302001 India
Phone
9829666655
Fax
Email
drmohitpoddar@gmail.com
Details of Contact Person Scientific Query
Name
Dr Swathi B
Designation
Associate Research Scientist
Affiliation
Himalaya Wellness Company
Address
Room No 301,3rd Floor, Clinical Pharmacology, Research and Development Makali, Tumkur Road, Bangalore Rural, KARNATAKA – 562162, India
Bangalore Rural KARNATAKA 562162 India
Phone
8067547232
Fax
Email
dr.swathi.b@himalayawellness.com
Details of Contact Person Public Query
Name
Ms Sushma C
Designation
Senior Clinical Research Associate
Affiliation
Himalaya Wellness Company
Address
Room No 301,3rd Floor, Clinical Pharmacology, Research and Development Makali, Tumkur Road, Bangalore Rural, KARNATAKA – 562162, India
Bangalore Rural KARNATAKA 562162 India
Phone
8067549881
Fax
Email
sushma.c@himalayawellness.com
Source of Monetary or Material Support
Himalaya Wellness Company
NH 4, Makali, Tumkur Road, Makali Aluru Main Road
Opposite to JCB
Bangalore Rural, Karnataka, 562162
India
Primary Sponsor
Name
Himalaya Wellness Company
Address
NH 4, Makali, Tumkur Road, Makali Aluru Main Road
Opposite to JCB
Bangalore Rural, Karnataka, 562162
India
Type of Sponsor
Pharmaceutical industry-Indian
Details of Secondary Sponsor
Name
Address
JSS Medical Research Asia Pacific Private Limited
Tower 2, 1st Floor, South Wing, L&T Business Park, Plot no 12/4, Sector 27 D, Delhi Mathura Road, Near Sarai Khwaja Metro Station, Faridabad -121003, Haryana, India
Brij Medical Centre Pvt Ltd, Room no 4, ground floor, Department of Pediatrics, 94-E, Near Panki Police Station Panki, Kanpur - 208020, Uttar Pradesh Kanpur Nagar UTTAR PRADESH
8176882317
drashishguptap01@gmail.com
Dr Mukund Sangamnerkar
Chinmay Institute Of Pediatrics
Chinmay institute of pediatrics, Room No. 1, Ground Floor, 210/B, Navi peth Pune-411030, Maharashtra Pune MAHARASHTRA
Raneshwar Multispecialty Hospital Ethic Committee A 4, Pashwa Nagar Society, Before Vasna Jakat Naka, Vasna Vadodara- 390015, Gujarat, India
Approved
Raneshwar Multispecialty Hospital Ethic Committee A 4, Pashwa Nagar Society, Before Vasna Jakat Naka, Vasna Vadodara- 390015, Gujarat, India
Approved
Raneshwar Multispecialty Hospital Ethic Committee A 4, Pashwa Nagar Society, Before Vasna Jakat Naka, Vasna Vadodara- 390015, Gujarat, India
Approved
Regulatory Clearance Status from DCGI
Status
Not Applicable
Health Condition / Problems Studied
Health Type
Condition
Healthy Human Volunteers
Healthy babies of 0-36 months
Intervention / Comparator Agent
Type
Name
Details
Comparator Agent
Not Applicable
Not Applicable
Intervention
Nourishing Baby soap
Himalaya Nourishing Baby soap leaves baby’s skin nourished, soft and smooth, it is enriched with the goodness of Honey, Milk, Castor Oil and Sunflower extracts to gently cleanse and protect baby’s skin from irritation and it has natural anti-inflammatory properties which help reduce itching and redness, ensuring soft, smooth and calm skin.
Duration of therapy will be 14 days.
1. No specific dose
2. Route of administration – Topical application
3. Frequency – As and when required
4. Duration of therapy – 14 days
Inclusion Criteria
Age From
0.00 Day(s)
Age To
36.00 Month(s)
Gender
Female
Details
1. Subjects in the age group of 0 to 36 months (inclusive of both genders).
2. Subjects in general good health as determined from a recent medical history and physical examination.
3. Subjects mother/legal representative, preferably mother willing to give a voluntary written informed consent and agree to comply with the study protocol.
ExclusionCriteria
Details
1. A known history or present allergic condition that may require medical attention.
2. Chronic illness which may influence the cutaneous assessment.
3. Subjects not willing to stop the use of other soaps during study period.
Method of Generating Random Sequence
Not Applicable
Method of Concealment
An Open list of random numbers
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
To evaluate the safety and efficacy of Test Product in study population.
Primary outcome:
1. Subjective assessment for tangle free and soft & shiny hair
2. Dermatology assessment for mildness and gentleness of baby’s skin.
Study duration: This study is planned for 15 days.
Timepoints: Baseline and 2 weeks.
Secondary Outcome
Outcome
TimePoints
Not Applicable
Not Applicable
Target Sample Size
Total Sample Size="500" Sample Size from India="500" Final Enrollment numbers achieved (Total)= "500" Final Enrollment numbers achieved (India)="500"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
Study Objective: To
evaluate the safety and efficacy of nourishing baby soap in 0-36 months babies
Study Design: An
open label, post marketing observational study.
Study Methodology:
1. Parents/Legally
Acceptable Representatives (LARs) of the baby will be provided with the
informed consent document and explained about the study in detail.
2. Babies who
fulfil the selection criteria will be enrolled into the study after written
informed consent.
3. The subject’s
parent /LAR will be provided with The Himalaya Nourishing Baby Soap, and they
will be instructed on the use the product by the study doctor/ coordinator.
4. Assessments will
be performed on Day 1/baseline and at the end of the study visit (Day 15) as
per the schedule of events.
5. If subjects
score for Local intolerance is scored 1= Mild, 2=Moderate, 3=Severe, then the
undesirable effect page to be completed.
6. All undesirable
effects to be followed up till the event is stabilized or 7days whichever is
earlier
Study duration: This
study is planned for 15 days. The subjects must use the test product for all 14
days.
Number of Subjects:
500 subjects will be enrolled.
Study Site: The study
will be conducted at Approximately 25 sites.
Directions to Use: Wet the baby’s body and
face with water, apply the soap generously, work up lather and rinse with
water.