| CTRI Number |
CTRI/2021/11/038154 [Registered on: 22/11/2021] Trial Registered Prospectively |
| Last Modified On: |
14/06/2022 |
| 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
|
Anti-Grey hair study |
|
Scientific Title of Study
|
To evaluate the Anti-grey efficacy of test regimen in healthy Indian human |
| Trial Acronym |
None |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| HAIR/HUGS/2021-29 Version 1.0 Dated 01 Oct 2021 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vidya Kuntoji |
| Designation |
Principal Investigator |
| Affiliation |
MS Clinical Research Pvt Ltd |
| Address |
Second floor, Evaluation room no. 1, 327/15, 1st Main Road, Cambridge layout, Ulsoor
Bangalore
KARNATAKA
560008
India |
| Phone |
08041125934 |
| Fax |
08040917253 |
| Email |
vidya@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 (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 |
| Dr Vidya Kuntoji |
MS Clinical Research Pvt. Ltd. |
Hair department, Second floor, Evaluation room no. 1, 327/15, 1st Main Road, Cambridge layout, Ulsoor
Bangalore
KARNATAKA |
08041125934
08040917253
vidya@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 |
Palitya |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Lifestyle | - | - | Dinacarya: Thrice a week, Ritucarya: , Acara Rasayana:, Other:Leave-on:RE57 Rinse Off:TL90, Pathya/Apathya:no, Pathya:, Apathya: | | 2 | Intervention Arm | Lifestyle | - | - | Dinacarya: Thrice a week, Ritucarya: , Acara Rasayana:, Other:Leave-on:MS71 Rinse Off:NK24, Pathya/Apathya:no, Pathya:, Apathya: | | 3 | Intervention Arm | Lifestyle | - | - | Dinacarya: Thrice a week, Ritucarya: , Acara Rasayana:, Other:Leave-on:YV42 Rinse Off:AX65, Pathya/Apathya:no, Pathya:, Apathya: | | 4 | Intervention Arm | Lifestyle | - | - | Dinacarya: Thrice a week, Ritucarya: , Acara Rasayana:, Other:Leave-on:GK32 Rinse Off:SJ79, Pathya/Apathya:no, Pathya:, Apathya: |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
42.00 Year(s) |
| Gender |
Both |
| Details |
1.Female and male subjects in the ratio of 2:1 in general good health.
2.Subjects in the age group 18-42 years (both the ages inclusive).
3.Subjects willing to give a written informed consent and agree to come for a regular follow up visit.
4.Subjects willing to apply TP as per instruction and they will not use any other hair product during the study period
5.Subjects willing to abide by and comply with the study protocol.
6.Subjects who have not participated in a similar investigation in the past three months.
7.Subjects who agree to refrain from using hair dye / hair colour /henna during the study period.
8.Subjects willing to refrain from any type of hair treatment like perming, straightening etc. during the study duration |
|
| ExclusionCriteria |
| Details |
1.Subjects who have undergone hair growth treatment within 3 months before screening into the study.
2.Subject who are currently using henna.
3.Subjects who have taken chemotherapy for cancer in the 6 months prior to start of the study or have a plan to do treatments during study.
4.Subjects (females) who are pregnant or lactating
5.Subjects who have had hair transplant.
6.A known history or present condition of allergic response/hypersensitivity to any cosmetic ingredients and pharmaceutical products.
7.Chronic illness which may influence the cutaneous state.
8.Subjects participating in other similar cosmetic or therapeutic trial within last three months
9.Subjects who have history of alcoholism, smoking and/ or psychiatric disorder including trichotillomania.
10.Menopausal female subjects as determined by medical history
11.Any history of underlying uncontrolled medical illness including diabetes mellitus, hypertension, HIV, hepatitis, severe anemia, serious disorder of heart and respiratory apparatus or any other serious medical illness.
12.Subjects having allergic reaction for oil |
|
|
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 Grey hair condition by expert/dermatologist assessment |
4 Months product and 1 Month regression |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Significant reduction and prevention in reoccurence of Grey hair condition by expert/dermatologist assessment |
4 Months product and 1 Month regression |
|
|
Target Sample Size
|
Total Sample Size="180"
Sample Size from India="180"
Final Enrollment numbers achieved (Total)= "159"
Final Enrollment numbers achieved (India)="159" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
25/10/2021 |
| Date of Study Completion (India) |
25/05/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
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 Grey hair benefits. After consenting and qualifying the inclusion and exclusion criteria subjects will be enrolled into the study. Post baseline assessments, test product will be dispensed to subjects as per randomization and subjects will be instructed to use the product thrice a week and evaluation assessments will be done at different times points over a period of 5 months. |