| CTRI Number |
CTRI/2022/06/043243 [Registered on: 14/06/2022] Trial Registered Prospectively |
| Last Modified On: |
21/12/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Ayurvedic Proprietary/Ayurvedic Medicine] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Product on various skin benefits |
|
Scientific Title of Study
|
Effect of Short term and long-term skin benefits of Ayurvedic product – A clinical study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SKIN/HUPS/2022-14 Version 1.0 Dated 29 Apr 2022 |
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
First floor, Evaluation room no. 1, 327/15, 1st Main Road, Cambridge layout, Ulsoor
Bangalore
KARNATAKA
560008
India |
| Phone |
08041125934 |
| Fax |
08040917253 |
| 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, Ulsoor
Bangalore
KARNATAKA
560008
India |
| Phone |
08041125934 |
| Fax |
08040917253 |
| Email |
sudhan@mscr.in |
|
|
Source of Monetary or Material Support
|
| Unilever Industries Pvt 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 |
| Dr Mukesh Ramnane |
MS Clinical Research Pvt. Ltd. |
First floor, Evaluation room no. 1, 327/15, 1st Main Road, Cambridge layout, Ulsoor
Bangalore
KARNATAKA |
08041125934
08040917253
mukesh.ramnane@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 |
Healthy human volunteers with uneven skin tone, mild to moderate dark spots- (Vyangam) |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Oil - DD21, Reference: NA, Route: Topical, Dosage Form: Taila, Dose: 0.5(mg), Frequency: bd, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (2) Medicine Name: 12 Weeks, Reference: NA, Route: NA, Dosage Form: Taila, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1. Female subjects between 25-45years of age.
2. Presence of pigment spots on face
3. Subjects with dry, oily or combination skin type.
4. Subjects who have not used fairness products or skin lightening product in past 1 month as on the screening day
5. Subject free of excessive hair, acne, cuts, abrasions, fissures, wounds, lacerations, or any other active skin conditions on the face.
6. Subject who agree not to use of any other skin lightening product/treatment/soap bar/home remedy on their face during the study period other that the study soap provided.
7. Subject who agrees not to carry out bleaching or any other skin care procedures on face during the study. |
|
| ExclusionCriteria |
| Details |
1. Subjects with known skin condition that may impact the assessment
2. Subject with any other signs of significant local irritation or skin disease.
3. Subject currently taking any medication, which the Investigator believes may influence the interpretation of the data.
4. Subject having chronic illness or had major surgery in the last year.
5. Subjects undergoing any treatment of any skin condition on their face/forearm/body.
6. Subjects allergic or sensitive to bar cleansing products, creams/lotions, artificial jewelry, or anything else.
7. Subjects pregnant or nursing.
8. Subjects taking medication including food supplements. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in severity in dark spots based on visual and instrumental assessment |
2, 4, 8 and 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in skin hydration by visual and instrumental assessment |
2, 4, 8 and 12 weeks |
|
|
Target Sample Size
|
Total Sample Size="53"
Sample Size from India="53"
Final Enrollment numbers achieved (Total)= "52"
Final Enrollment numbers achieved (India)="52" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
15/06/2022 |
| Date of Study Completion (India) |
23/11/2023 |
| 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
|
Nil |
|
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 obtaining Informed consent form and qualifying the inclusion and exclusion criteria, subjects will be enrolled into the study. Post wash out period, test product will be dispensed to subjects. Post base line assessment subjects will be instructed to use the product every day, twice and evaluation assessments will be done at different times points over a period of 3 months. |