CTRI/2023/10/058787 [Registered on: 18/10/2023] Trial Registered Prospectively
Last Modified On:
24/11/2023
Post Graduate Thesis
No
Type of Trial
PMS
Type of Study
Drug
Study Design
Single Arm Study
Public Title of Study
To evaluate the safety and efficacy of soothing baby rub in 0-36 months babies.
Scientific Title of Study
Post Marketing Observational Study PMOS To Evaluate the Safety and Efficacy of HBCR – 011805 Soothing Baby Rub In 0-36 Months Babies.
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
HWC/MSCD/CPD/010/2023 Version No: 1.0, Dated 19 July 2023
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Mohit Poddar
Designation
Consultant
Affiliation
Poddar Hospital
Address
Department of Pediatrics, Room No. 1, Ground Floor, 3510AB, Langar Ke Balaji Ka Rasta, Gangori Bazar, Jaipur 302001, Rajasthan
Jaipur RAJASTHAN 302004 India
Phone
09829666655
Fax
Email
drmohitpoddar@gmail.com
Details of Contact Person Scientific Query
Name
Dr Soorya Narayan
Designation
Manager- Clinical Operations - MSCD & RD
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
918067549919
Fax
Email
dr.sooryanarayan.h@himalayawellness.com
Details of Contact Person Public Query
Name
Dr Swathi B
Designation
Clinical Team Lead - Personal Care - MSCD & RD
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
918067547232
Fax
Email
dr.swathi.b@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
Soothing baby rub helps baby relax and get rid of a congested nose. Baby rub has many benefits for the baby, like calms, comforts and mild on baby’s skin, helps promote easy
breathing and ease discomfort associated with nasal congestion and stuffy nose. It also promotes restful and peaceful all- night sleep, strengthens mother and baby bond.
Himalaya Soothing Baby Rub is an easy-to-apply, non-greasy gentle and effective soothing balm specially formulated with a special blend of natural oils of Eucalyptus, Rosemary, and Indian Frankincense. This gentle yet effective baby rub helps ease breathing, gently soothes, and calms baby and reduces discomfort associated with nasal congestion. The calming aroma of the natural oils relaxes and comforts the baby into a restful all-night sleep.
Dose- NA Frequency- SOS, Route- Topical, Duration- 7 Days.
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.
2. Subject with acute cold symptoms having signs and symptoms as listed below
a. Nasal congestion/blockage,
b. Itchy nose,
c. Sneezing,
d. Runny nose.
3. Subjects in general good health as determined from a recent medical history and physical examination.
4. Subjects mother/legal representative willing to give a voluntary written parent consent and agree to comply with the study protocol.
ExclusionCriteria
Details
1. Subjects with a known history or present condition of allergic response to any other vapo rub, balm, or its components or ingredients as in the test product.
2. Subjects having history or present condition of respiratory diseases, or any significant allergies.
3. Subjects requiring medical treatment for the indicated symptoms.
4. Chronic illness which may influence the cutaneous assessment.
5. Subjects who have participated in a similar clinical investigation in the past four weeks
Method of Generating Random Sequence
Not Applicable
Method of Concealment
Not Applicable
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
To evaluate the safety and efficacy of Test Product in study population
7 days.
Secondary Outcome
Outcome
TimePoints
NA
NA
Target Sample Size
Total Sample Size="500" Sample Size from India="500" 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
Post Marketing Surveillance
Date of First Enrollment (India)
26/10/2023
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="5" Days="0"
Recruitment Status of Trial (Global)
Not Applicable
Recruitment Status of Trial (India)
Not Yet Recruiting
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
STUDY
OBJECTIVE: To evaluate the safety and efficacy of soothing baby
rub in 0-36 month’s babies with acute cold symptoms.
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 Parent consent
document and explained about the study in detail.
2. Babies who fulfil the
selection criteria will be enrolled into the study after written parent consent.
3. The subject’s parent
/LAR will be provided with The Himalaya Soothing Baby Rub , 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 at symptoms
resolution or day 7 whichever is earlier 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 till symptoms resolution or day 7 (+ 1 day) whichever is
earlier.
Number
of Subjects: 500 subjects will be enrolled.
Study
Site: Thestudy will be conducted at 20 sites.
Directions to Use:Take a small amount of Himalaya Soothing Baby
Rub onto your fingertips and gently apply on your baby’s chest, neck, and back.
Use as and whenever required