CTRI/2023/10/058786 [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 baby tummy roll on in 0-36 months babies.
Scientific Title of Study
Post Marketing Observational Study PMOS To Evaluate the Safety and Efficacy of HBTM 102109 Baby Tummy Roll On in 0-36 Months Babies
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
HWC/MSCD/CPD/012/2023 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
9829666655
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
Basement Room No. 1, 269, Lane no. 4, Vashishth Marg, Raja Park, Jaipur 302004 Jaipur RAJASTHAN
09929779306
medihubjaipur@gmail.com
Dr Pramod Jog
Medipoint Hospitals Pvt Ltd
Clinic Building, 3rd floor, Department of Pediatrics, 241/1, New
D P Road, Aundh
Baner Boundary,
Baner Road, Pune - 411007,
Maharashtra,
India Pune MAHARASHTRA
09423309677
drpramod.medipoint@gmail.com
Dr Prashanth M V
Medstar Specility Hospital
641/17/1/3, 2nd Floor, Kodigehalli Main Road, Sahakarnagar, Bangalore, Karanataka, India 560092 Bangalore KARNATAKA
Baby Tummy Roll on is a pure, natural formula that soothes and relaxes babys tummy. This
comforting oil is formulated with the gentlest hing oil, saunf oil and calming natural essential oils of Chamomile, Frankincense and Cardamom. Massage has many benefits for the baby, provide calms, comforts on baby’s skin, help calm the baby from infantile colic/ ease’s tummy discomfort, relieves gas & bloating, and promotes peaceful sleep, strengthens mother and baby bond. Himalaya Baby Tummy Roll On is specially made with a blend of five natural oils to comfort the baby and provide relief from tummy discomfort and infantile colic associated with indigestion and gas. This gentle and effective tummy oil roll is easy to apply too. The soothing aroma of the oils gently calms and relaxes, promoting a restful all-night sleep.
frequency -SOS Rout of Administration-Topical Duration- 03 Days
Comparator Agent
NA
NA
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. Subjects with at least any one condition such as colic pain, indigestion, constipation, gas and bloating.
3. Subjects not using similar products during the study period.
4. Subjects who have not participated in similar clinical trial in the past 4 weeks
5. Subjects in general good health as determined from a recent medical history and physical examination.
6. Subject’s mother/legal guardian willing to give a voluntary written parent consent and agree to complete study activities and come for regular follow up with subject
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 tummy oil or any medication for this indication during study period
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,Safety and efficacy will be assessed at the end of the study visit.
3 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"
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 baby tummy roll
on in 0-36 month’s babies with at least any one condition such as colic
pain, indigestion, constipation, gas and bloating.
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 baby tummy roll on, 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 till symptoms resolution or day 3 + 1 day
whichever is earlier (end of the study visit) 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 3 (+ 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:Apply directly on baby’s stomach around the
naval area. Gently massage with hand if required. Keep using until baby gets
better.