| CTRI Number |
CTRI/2021/08/035784 [Registered on: 18/08/2021] 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 |
Other |
|
Public Title of Study
|
Multiple use test to evaluate the skin benefits of ayurvedic products |
|
Scientific Title of Study
|
Efficacy Evaluation of Ayurvedic products – a short term study |
| Trial Acronym |
None |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SKIN/HUCA/2021-18 Version 1.0 Dated 30 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 |
Ground Floor, Room no. 1, 327/15, 1st main road, cambridge layout,
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,
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 |
Prabhahani/Rukshatha |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Lifestyle | - | - | Dinacarya: Twice daily for 4 days and one time on day 5, Ritucarya: , Acara Rasayana:, Other:AT13, Pathya/Apathya:no, Pathya:, Apathya: | | 2 | Intervention Arm | Lifestyle | - | - | Dinacarya: Twice daily for 4 days and one time on day 5, Ritucarya: , Acara Rasayana:, Other:LK78, Pathya/Apathya:no, Pathya:, Apathya: | | 3 | Intervention Arm | Lifestyle | - | - | Dinacarya: Twice daily for 4 days and one time on day 5, Ritucarya: , Acara Rasayana:, Other:PQ33, Pathya/Apathya:no, Pathya:, Apathya: | | 4 | Intervention Arm | Lifestyle | - | - | Dinacarya: Twice daily for 4 days and one time on day 5, Ritucarya: , Acara Rasayana:, Other:EV39, Pathya/Apathya:no, Pathya:, Apathya: | | 5 | Intervention Arm | Lifestyle | - | - | Dinacarya: Twice daily for 4 days and one time on day 5, Ritucarya: , Acara Rasayana:, Other:KL31, Pathya/Apathya:no, Pathya:, Apathya: | | 6 | Intervention Arm | Lifestyle | - | - | Dinacarya: Twice daily for 4 days and one time on day 5, Ritucarya: , Acara Rasayana:, Other:BV54, Pathya/Apathya:no, Pathya:, Apathya: | | 7 | Intervention Arm | Lifestyle | - | - | Dinacarya: Twice daily for 4 days and one time on day 5, Ritucarya: , Acara Rasayana:, Other:NN28, Pathya/Apathya:no, Pathya:, Apathya: | | 8 | Intervention Arm | Lifestyle | - | - | Dinacarya: Twice daily for 4 days and one time on day 5, Ritucarya: , Acara Rasayana:, Other:VC74, Pathya/Apathya:no, Pathya:, Apathya: |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1.Healthy male and female subjects between 18-45 years of age.
2.Subjects with dry skin as per instrument assessment
3.Subjects with sufficiently long and broad forearms to accommodate the test sites
4.Subjects with uniform skin tone on volar forearm
5.Subjects who have not participated in any clinical product evaluation test in the past 1 month
6.Subjects willing to give a voluntary written informed consent for activities in the study for imaging and agree to come for regular study visits
7.Subjects willing to abide and comply with the study protocol
8.Subjects who are willing not to participate in any other clinical study during participation in the current study.
9.Subjects free of excessive hair, cuts, abrasions, fissures, wounds, lacerations, or any other active skin conditions on the forearm.
10.Subjects who agree not to use of any other product/treatment/soap bar on their forearm during the study period other than product provided
11.Subjects who agree not to carry out bleaching or any other procedures on forearm during the study period. |
|
| ExclusionCriteria |
| Details |
1.A known history or present condition of allergic response to any sunscreen products, cosmetics products, bathing soaps, detergent powder or medicine
2.Subjects with visible photo-damage on their forearms
3.Subjects having active skin diseases which will interfere with assessments
4.Subjects on oral and topical medications which will compromise the study.
5.Suffering from autoimmune diseases like thyroid autoimmunity or diabetes mellitus.
6.Subjects who are pregnant, lactating or nursing |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Dermatologist assessment on different skin parameters |
Baseline and Post treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Instrument assessment of different skin parameters |
Baseline and Post treatment |
|
|
Target Sample Size
|
Total Sample Size="55"
Sample Size from India="55"
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
23/08/2021 |
| Date of Study Completion (India) |
24/09/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
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, Products under test will be randomized and
applications will be done on fore arm. Expert and instrument assessment will be done during all the treatment days.
|