| CTRI Number |
CTRI/2020/10/028193 [Registered on: 01/10/2020] Trial Registered Prospectively |
| Last Modified On: |
12/05/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [safety and efficacy] |
| Study Design |
Other |
|
Public Title of Study
|
Safety and efficacy of baby diaper pant |
|
Scientific Title of Study
|
An Open label, Clinical Study to Evaluate the Safety and efficacy of HSBP-121901 in babies of 0 – 36 months of age |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| C3B00293, HDC/CP/PP/040/2020, Version: 01, Dated 17 Jul 20 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nayan Patel |
| Designation |
Principal Investigator |
| Affiliation |
Cliantha Research |
| Address |
Consumer Research Department
Garden View Corporate House No 7
Opp Auda Garden
Bodakdev Ahmedabad 380054 India
Ahmadabad
GUJARAT
380054
India |
| Phone |
9909013286 |
| Fax |
07966219549 |
| Email |
nkpatel@cliantha.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nayan Patel |
| Designation |
Principal Investigator |
| Affiliation |
Cliantha Research |
| Address |
Consumer Research Department
Garden View Corporate House No 7
Opp Auda Garden
Bodakdev Ahmedabad 380054 India
Ahmadabad
GUJARAT
380054
India |
| Phone |
9909013286 |
| Fax |
07966219549 |
| Email |
nkpatel@cliantha.com |
|
Details of Contact Person
Public Query
|
| Name |
Ms Maheshvari Patel |
| Designation |
Associate Director-Consumer Research |
| Affiliation |
Cliantha Research |
| Address |
Consumer Research Department
Garden View Corporate House No 7
Opp Auda Garden
Bodakdev Ahmedabad 380054 India
Ahmadabad
GUJARAT
380054
India |
| Phone |
9909013236 |
| Fax |
07966219549 |
| Email |
mnpatel@cliantha.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
The Himalaya Drug Company |
| Address |
Makali, Bengaluru, Karnataka, 562162, India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Not applicable |
Not applicable |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Nayan Patel |
Cliantha Research |
Consumer Research Department
Garden View Corporate House No 7
Opp Auda Garden
Bodakdev Ahmedabad 380054 India
Ahmadabad
GUJARAT |
9909013286
07966219549
nkpatel@cliantha.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Riddhi Medical Nursing Home Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Babies 0 – 36 months of age |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
HSBP-121901 |
Pull out one diaper pant from the pack, pull the
pant to fit baby’s waist and ensure that the waist area is
not folded over. Use daily |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
36.00 Month(s) |
| Gender |
Both |
| Details |
1. Babies in the age group of 0 to 36 months (inclusive of both genders)
2. Babies in general good health as determined from recent medical history and the Pediatrician.
3. Baby’s mother/legal representative, preferably mother willing to give a voluntary written informed consent and agree to come for regular follow up.
4. Baby’s mother/legal representative, preferably mother willing to abide by and comply with the study protocol.
5.Babies should not participate in any other clinical study during participation in the current study.
6. Babies delivered after complete gestation (> 38 weeks). |
|
| ExclusionCriteria |
| Details |
1. Babies with a known history or present condition of allergic response to any other Diapers, toiletries or its components or ingredients as in the test product.
2. Babies with diarrhea/ bowel incontinence
3. Babies with diaper rashes or any allergies in the diaper area.
4. Any pre-existing systemic disease necessitating long term medications and other dermatological problems.
5. Babies requiring incubators/ ventilators or C-PAP.
6. Babies 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
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Mildness gentleness and irritation as assessed by
pediatrician assessment Scoring
2. subjective questionnaire for - helps to prevent diaper rash
less frequent change of diapers Withstand
multiple wetting
overnight use Undisturbed restful
sleep for the baby
Less crying
less cranky after
waking up
Provides soft and tender care with less
friction of the diaper
No incidence of leakage of
urine or feces
Ease of diaper application and removal
overall satisfaction of the product |
Day 1 (Baseline) and Day 8 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Local intolerance of the product assessed by
Pediatrician
2. Continuous monitoring of adverse event during the
study period. |
Day 1 (Baseline) and Day 8 |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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
|
N/A |
|
Date of First Enrollment (India)
|
10/10/2020 |
| 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="0"
Days="8" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Suspended |
|
Publication Details
|
Not Applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is an Open-Label, Clinical Study to Evaluate the Safety and efficacy of HSBP-121901 in babies if 0 – 36 months of age. As the newborn skin easily become dry and the skin very vulnerable to infections. HSBP- 121901 have many advantages like being hygienic for the infant’s skin, reducing rashes and irritations and also preventing infections caused by diapers. This study evaluates the benefits of baby diaper pants in terms of mildness, gentleness and non-irritability on baby’s skin and also the prevention of diaper rashes, less frequent change of diapers, Withstand multiple wettings, overnight use, Undisturbed, restful sleep for the baby; Less crying, less cranky after waking up, Provides soft and tender care with less friction of the diaper, No incidence of leakage of urine or faeces, Ease of diaper application and removal. |