| CTRI Number |
CTRI/2022/08/044645 [Registered on: 04/08/2022] Trial Registered Prospectively |
| Last Modified On: |
02/02/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cosmeceutical] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical study to evaluate the safety and efficacy of a Nursing Gel in healthy pregnant females and lactating females with sore & cracked nipples. |
|
Scientific Title of Study
|
An open-label, single-arm study to evaluate the efficacy and safety of a Nursing Gel in healthy pregnant female (3rd trimester) and lactating female (post pregnancy mother having 0 month to 3 months old baby) subjects with sore & cracked nipples. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| C3B00047 Version: 01, Dated 15 Jul 22 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Parth Joshi |
| 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 |
8000085049 |
| Fax |
917966219549 |
| Email |
pjoshi@ofacto.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Parth Joshi |
| Designation |
Principal Investigator |
| Affiliation |
Cliantha Research |
| Address |
Consumer Research Department,
Garden View Corporate House No 7,
Opp Auda Garden,
Bodakdev, Ahmedabad 380054, India
GUJARAT
380054
India |
| Phone |
8000085049 |
| Fax |
917966219549 |
| Email |
pjoshi@ofacto.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Simran Sethi |
| Designation |
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 |
9825784942 |
| Fax |
917966219549 |
| Email |
ssethi@ofacto.com |
|
|
Source of Monetary or Material Support
|
| Zydus Wellness Ltd.
Plot No 115/5 TP Scheme No 51,
Beside Bliss Apartment,
Opp Viola Apartment,
Ambli Bopal Road,
Ahmedabad 38001, India |
|
|
Primary Sponsor
|
| Name |
Zydus Wellness Ltd |
| Address |
Plot No 115/5 TP Scheme No 51,
Beside Bliss Apartment,
Opp Viola Apartment,
Ambli Bopal Road,
Ahmedabad 38001, India |
| Type of Sponsor |
Other [Health and Hygiene] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Parth Joshi |
Cliantha Research |
Consumer Research Department,
Garden View Corporate House No 7,
Opp Auda Garden,
Bodakdev, Ahmedabad 380054, India
Ahmadabad
GUJARAT |
8000085049
917966219549
pjoshi@ofacto.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| OM |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N645||Other signs and symptoms in breast, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
Nursing Gel |
Approximately 0.5 gm of test product to be applied on nipples and surrounding area.
For lactating mothers, product will be used after every feed for a period of 14 days and for pregnant females, product will be used thrice a day. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1) Sex: Females, either of the following
a. Healthy pregnant females (3rd trimester).
b. Lactating females (post pregnancy mothers having 0 to 3 months old baby).
2) Subjects with mild to moderate nipple soreness/pain based on visual analogue scale (VAS).
3) For Post Pregnancy Mothers: Subjects having history of delivery within 42 weeks.
4) For Pregnant females: Primipara (woman who is giving birth for the first time) subjects, who are diagnosed as pregnant female by gynaecologist. |
|
| ExclusionCriteria |
| Details |
1) Subjects having contraindications for breastfeeding
2) Newborn with no oral, palatal or maxillofacial abnormalities.
3) Subjects with history of development of any breast problem: Mastitis, engorgement etc.
4) Subjects not willing to discontinue other nipple crack preventing method during application.
5) Subjects who are not taking any pain management medication e.g., NSAID’s, pain killers, etc.
6) Participation in a similar clinical study within the previous 90 days.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) Gynecological assessment of nipple soreness/pain using visual analogue scale (VAS).
2) Dermatological assessment of nipple skin dryness, nipple skin roughness, nipple skin redness/erythema, burning, itching, stinging using 5-point scoring scale. |
Baseline, Day 02, Day 14 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessment of skin hydration using Corneometer /Moisturemeter SC. |
Baseline, Day 02, Day 14 |
| Assessment of skin barrier function using TEWAmeter /Vapometer. |
Baseline, Day 02, Day 14 |
| Subject Satisfaction Questionnaire and Product Response Index (Perception about Product). |
Baseline, Day 02, Day 14 |
| Digital Photographs of the nipple and surrounding area |
Baseline, Day 02, Day 14 |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/08/2022 |
| Date of Study Completion (India) |
30/11/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="14" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The potential
subjects will be screened as per the inclusion and exclusion criteria only
after obtaining written informed consent from the subjects.
There are total 4 visits in the study i.e.
·
Visit 01:
Screening Visit (within 30 days prior to day 01)
·
Visit 02:
Enrollment (Day 01)
·
Visit 03:
Evaluation phase (Day 02 + 1 day)
·
Visit 04:
Evaluation phase and End of the study (Day 14 ± 2 days)
Before
entering the facility, at security check-post, subjects will be asked for
pre-entry scrutiny check for COVID-19 symptoms. Study can be conducted in
multiple batches (set of subjects) in order to follow the norms of covid-19
restrictions.
Instrumental
assessment, dermatological assessments and questionnaires will be assessed.
Safety will be assessed throughout the study by monitoring of adverse events. |