| CTRI Number |
CTRI/2021/07/035266 [Registered on: 29/07/2021] 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 of 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/URAC/2021-13 Version 1.0 Dated 05 Jul 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 |
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 |
Mukhadushika |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Lifestyle | - | - | Dinacarya: Twice Daily, Ritucarya: , Acara Rasayana:, Other:TN25, Pathya/Apathya:no, Pathya:, Apathya: | | 2 | Intervention Arm | Lifestyle | - | - | Dinacarya: Twice Daily, Ritucarya: , Acara Rasayana:, Other:NP74, Pathya/Apathya:no, Pathya:, Apathya: | | 3 | Intervention Arm | Lifestyle | - | - | Dinacarya: Twice Daily, Ritucarya: , Acara Rasayana:, Other:MH90, Pathya/Apathya:no, Pathya:, Apathya: | | 4 | Intervention Arm | Lifestyle | - | - | Dinacarya: Twice Daily, Ritucarya: , Acara Rasayana:, Other:CC01, Pathya/Apathya:no, Pathya:, Apathya: |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1.Female subject between 18-35 years of age.
2.Each subject with mild to moderate acne and with oily/ acne prone skin
3.Subject who agree not to use of any other skin lightening product/treatment/soap bar/home remedy/bleaching on their face during the study period
4.Subjects who agree not use any face packs, facials, make up and sunscreens on their face during the study period
5.Subject to agree not to carry out bleaching or any other skin care procedures on face during the study period. |
|
| 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 with dry to very dry skin, which will interfere with the test assessments.
6.Subjects undergoing any treatment of any skin condition on their face/forearm/body.
7.Subject allergic or sensitive to bar cleansing products, creams/lotions, artificial jewellery or anything else.
8.Subject pregnant or nursing.
9.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 acne condition by expert/dermatologist assessment |
4 weeks product and 1 week regression |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Significant improvement in other acne associated skin conditions |
4 weeks product and 1 week regression |
|
|
Target Sample Size
|
Total Sample Size="240"
Sample Size from India="240"
Final Enrollment numbers achieved (Total)= "215"
Final Enrollment numbers achieved (India)="215" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
04/08/2021 |
| Date of Study Completion (India) |
12/01/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
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. Post wash out period, 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
at different times points over a period of 5 weeks. |