| CTRI Number |
CTRI/2021/07/034591 [Registered on: 05/07/2021] Trial Registered Prospectively |
| Last Modified On: |
07/02/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Ayurvedic Proprietary Medicine] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Skin Benefit Study For The Test Product |
|
Scientific Title of Study
|
An efficacy test to evaluate the skin benefits with regular use of Ayurvedic product |
| Trial Acronym |
None |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SKIN/URAR/2021-12 Version 1.0 Dated 18 Jun 2021 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mukesh Ramnane |
| Designation |
Principal Investigator |
| Affiliation |
MS Clinical Research Pvt Ltd |
| Address |
First floor, Evaluation room no. 1,327/15, 1st Main Road Cambridge layout, Ulsoor
Bangalore
KARNATAKA
560008
India |
| Phone |
08041125934 |
| Fax |
08040917253 |
| Email |
mukesh.ramnane@mscr.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Ritambhara |
| Designation |
Director- Business and Operation |
| Affiliation |
MS Clinical Research Pvt Ltd |
| Address |
Room no.2, Ground floor,327/15, 1st Main Road Cambridge layout, Ulsoor
Bangalore
KARNATAKA
560008
India |
| Phone |
08041125934 |
| Fax |
|
| Email |
ritambhara@mscr.in |
|
Details of Contact Person
Public Query
|
| Name |
Sudhanthiran S |
| Designation |
Study Manager |
| Affiliation |
MS Clinical Research Pvt Ltd |
| Address |
First Floor, Room no. 1, Councelling Area, 327/15, 1st main road, cambridge layout,
Bangalore
KARNATAKA
560008
India |
| Phone |
08041125934 |
| Fax |
|
| Email |
sudhan@mscr.in |
|
|
Source of Monetary or Material Support
|
| Unilever Industries (P) Ltd |
|
|
Primary Sponsor
|
| Name |
Unilever Industries Pvt Ltd |
| Address |
Unilever Industries (P) Ltd
Research Center Stores
B.D Sawant Marg, Chakala
Andheri (East)
Mumbai – 400099, India |
| Type of Sponsor |
Other [FMCG(Fast moving Consumer Goods)] |
|
|
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 |
| Ritambhara |
MS Clinical Research Pvt. Ltd. |
327/15, 1st Main Road
Cambridge layout, Ulsoor
Bangalore
KARNATAKA |
08041125934
ritambhara@mscr.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Clinicom Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Skin Barrier Health (PRABHAHANI and RUKSHATHA) |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
None |
NA |
| Intervention |
Product 1 - FU92 |
Twice daily for 6 weeks |
| Intervention |
Product 2 - KL31 |
Twice daily for 6 weeks |
| Intervention |
Product 3 - BV54 |
Twice daily for 6 weeks |
| Intervention |
Product 4 - LK78 |
Twice daily for 6 weeks |
| Intervention |
Product 5 - PQ33 |
Twice daily for 6 weeks |
| Intervention |
Product 6 - NN28 |
Twice daily for 6 weeks |
| Intervention |
Product 7 - VC74 |
Twice daily for 6 weeks |
| Intervention |
Product 8 - EV39 |
Twice daily for 6 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1.Male and female subjects between 18 to 45 years of age. (both age inclusive).
2.Healthy male and female subjects as per their medical history and medical examination.
3.Subjects with normal, oily or combination in skin type.
4.Subjects with common skin ailments.
5.Subjects who have not used fairness products in past 1 month as on the screening day.
6.Subject who agree not to use of any other products on their face during the study period.
7.Subject to agree not to carry out bleaching or any other skin care procedures on face during the study period.
8.Subject to agree to remove all jewellery on/around face (e.g., necklace, earrings, if possible, nose ring) during imaging. |
|
| ExclusionCriteria |
| Details |
1.Subjects presenting any skin ailment that may require medical intervention as per the investigator’s discretion.
2.Subjects with known skin condition that may impact the assessment.
3.Subject with any other signs of significant local irritation or skin disease.
4.Subject currently taking any medication, which the Investigator believes may influence the interpretation of the data.
5.Subject having chronic illness or had major surgery in the last year.
6.Subjects with dry to very dry skin, which will interfere with the test assessments.
7.Subjects undergoing any treatment of any skin condition on their face/forearm/body.
8.Subject allergic or sensitive to bar cleansing products, creams/lotions, artificial jewellery or anything else.
9.Subject pregnant or nursing.
10.Subjects taking medication including food supplements. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Significant improvement in skin conditions by Expert assessment |
Baseline, 2 weeks, 4 weeks & 6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Significant improvement in skin conditions by instrumental assessment |
Baseline, 2 weeks, 4 weeks & 6 weeks |
|
|
Target Sample Size
|
Total Sample Size="576"
Sample Size from India="576"
Final Enrollment numbers achieved (Total)= "508"
Final Enrollment numbers achieved (India)="508" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
07/07/2021 |
| Date of Study Completion (India) |
25/10/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Study will be conducted to assess the efficacy of test product in imparting skin benefits. After consenting and qualifying the inclusion and exclusion criteria subjects will be enrolled into the study. Test product will be dispensed to subjects as per randomization and post base line assessment. Subjects will be instructed to use the product twice a day and evaluation assessments will be done on week 2,week 4 and week 6. |