CTRI/2021/09/036991 [Registered on: 30/09/2021] Trial Registered Prospectively
Last Modified On:
24/04/2023
Post Graduate Thesis
No
Type of Trial
PMS
Type of Study
Other (Specify) [PMS ]
Study Design
Single Arm Study
Public Title of Study
To evaluate the safety and efficacy of gentle baby wipes_extra large wipes in 0-36 months babies
Scientific Title of Study
PMOS to evaluate the safety and efficacy of gentle baby wipes_extra large wipes in 0-36 months babies
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
HDC/MSCD/CPD/028/2021, 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
Jaipur RAJASTHAN 302004 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
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
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
Atmaram Child Care, Room -01, Ground Floor, Department of Pediatrics,53Y/128, Y Block, Kidwai Nagar, Naubasta, Kanpur UP 208011 Kanpur Nagar UTTAR PRADESH
Brij Medical Centre Pvt Ltd, Room no 4, Ground Floor, Department of Pediatrics, 94-E, Near Panki Police Station Panki, Kanpur, UP 208020 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
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
Intervention
Gentle baby wipes/Extra-large wipes
Test Product offers the convenience of cleansing the baby from head to toe using just one wipe. It is infused with goodness of Aloe Vera and Indian Lotus extracts, It helps in cleansing and refreshing the baby’s skin leaving it soft and supple.
Duration of therapy will be 14 days.
Comparator Agent
Not Applicable
Not Applicable
Inclusion Criteria
Age From
0.00 Day(s)
Age To
36.00 Month(s)
Gender
Both
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 wipes 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.
Study duration: This study is planned for 15 days.
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 gentle baby wipes in 0-36 months babies
STUDY
DESIGN: An open label, post marketing observational study.
Study Methodology:
• Parents/Legally
Acceptable Representatives (LARs) of the baby will be provided with the
informed consent document and explained about the study in detail.
• Babies who fulfil
the selection criteria will be enrolled into the study after written informed
consent.
• The subject’s
parent /LAR will be provided with The Himalaya gentle baby wipes/extra-large
wipes, and they will be instructed on the use the product by the study doctor/
coordinator.
• Assessments will
be performed on Day 1/baseline and at the end of the study visit (Day 15) as
per the schedule of events.
• If subjects score
for Local intolerance is scored 1= Mild, 2=Moderate, 3=Severe, then the
undesirable effect page to be completed.
• 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: Pull out Wipes and
gently clean the baby, carefully reseal the pack flap to keep wipes fresh and
moist for the future (Use 1 extra-large baby wipes to clean whole body).