CTRI/2021/10/037163 [Registered on: 07/10/2021] Trial Registered Prospectively
Last Modified On:
24/04/2023
Post Graduate Thesis
No
Type of Trial
PMS
Type of Study
Other (Specify) [Other (PMS)]
Study Design
Single Arm Study
Public Title of Study
To evaluate the safety and efficacy of prickly heat baby powder in 0-36 months babies.
Scientific Title of Study
PMOS to evaluate the safety and efficacy of prickly heat baby powder in 0-36 months babies.
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
HDC/MSCD/CPD/026/2021 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 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
08067547232
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
08067549881
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
Prickly Heat Baby Powder
Himalaya Prickly Heat Baby Powder keeps the baby’s skin cool and fresh by reducing the prickly heat. It contains Yashad Bhasma an anti-inflammatory help reduce excess sweat and soothes irritated skin, Karanja helps reduce itching, Neem helps protect skin from infection through its antimicrobial action and Ushira possess astringent, antimicrobial and antiseptic activity.
Inclusion Criteria
Age From
0.00 Day(s)
Age To
36.00 Month(s)
Gender
Both
Details
Subjects in general good health as determined from a recent medical history and physical examination.
Subjects showing at least 1 or more symptoms of prickly heat such as itching, redness and rashes due to friction (in elbows, arms and knees etc).
Subjects mother/legal representative, preferably mother willing to give a voluntary written informed consent and agree to comply with the study protocol.
ExclusionCriteria
Details
A known history or present allergic condition that may require medical attention.
Chronic illness which may influence the cutaneous assessment.
Subjects not willing to stop the use of other powders 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 prickly
heat baby powder 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 prickly
heat baby powder, 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: Sprinkle Himalaya
Prickly Heat Baby Powder on to your palms and apply on baby’s skin after bath,
nappy changes and before bed-time.