| CTRI Number |
CTRI/2024/10/074760 [Registered on: 04/10/2024] Trial Registered Prospectively |
| Last Modified On: |
01/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Grey hair study on male and female subjects for a period of 4 months |
|
Scientific Title of Study
|
A study to evaluate the efficacy of test product in improving dark hair density |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| HAIR/HUGS/2024-31 Version 1.0 dated 29 Aug 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mukta Sachdev |
| Designation |
Principal investigator |
| Affiliation |
MS Clinical Research Pvt. Ltd |
| Address |
MS Clinical Research Pvt. Ltd
Second floor, Hair Department
327 15, 1st Main Road
Cambridge Layout, Ulsoor
Bangalore-560008,
Karnataka, India
Bangalore
KARNATAKA
560008
India |
| Phone |
918040917253 |
| Fax |
|
| Email |
mukta.sachdev@msclinical.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Pranisha K |
| Designation |
Ayurvedic doctor |
| Affiliation |
MS Clinical Research Pvt. Ltd |
| Address |
MS Clinical Research Pvt. Ltd
Second floor, Hair Department
327 15, 1st Main Road
Cambridge Layout, Ulsoor
Bangalore-560008,
Karnataka, India
Bangalore
KARNATAKA
560008
India |
| Phone |
918040917253 |
| Fax |
|
| Email |
pranisha.k@msclinical.com |
|
Details of Contact Person
Public Query
|
| Name |
Sudhanthiran S |
| Designation |
Study Manager |
| Affiliation |
MS Clinical Research Pvt. Ltd |
| Address |
MS Clinical Research Pvt. Ltd
Second floor, Hair Department
327 15, 1st Main Road
Cambridge Layout, Ulsoor
Bangalore-560008,
Karnataka, India
Bangalore
KARNATAKA
560008
India |
| Phone |
918040917253 |
| Fax |
|
| Email |
sudhan@msclinical.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Hindustan Unilever Ltd |
| Address |
B D Sawant Marg, Chakala,
Andheri (East) Mumbai, 27 – 400099
Maharashtra, India
|
| Type of Sponsor |
Other [FMCG] |
|
|
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 Mukta Sachdev |
MS Clinical Research Pvt. Ltd |
Second floor, Hair Department 327 15, 1st Main Road Cambridge Layout, Ulsoor Bangalore-560008 Karnataka, India
Bangalore
KARNATAKA |
918040917253
mukta.sachdev@msclinical.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| CLINICOM |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L678||Other hair color and hair shaft abnormalities. Ayurveda Condition: AKALAPALITAHÂ (KEVALAPITTA), |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Hair care product, Reference: NA, Route: Topical, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 3(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 4 Months, anupAna/sahapAna: Yes(details: -), Additional Information: Product code HX21 |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
42.00 Year(s) |
| Gender |
Both |
| Details |
1. Participants having grey hair
2. Male and female participants
3. Participants in the age group 20-42 years (both the ages inclusive).
4. Participants willing to give a written informed consent and who agree to come for regular follow up visits.
5. Participants willing to trim their hair.
6. Participants willing to apply the test product as per instructions. |
|
| ExclusionCriteria |
| Details |
1. Participant who are currently using henna/dye.
2. Participants using any hair product which impact hair colour will be excluded.
3. Participants 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. Female subjects who are pregnant or lactating (self-declared).
5. Participants who have had hair transplant.
6. Chronic illness which may influence the scalp condition. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in dark hair density |
1 month, 2 month, 3 month, 4 month. |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
Final Enrollment numbers achieved (Total)= "38"
Final Enrollment numbers achieved (India)="38" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
12/10/2024 |
| Date of Study Completion (India) |
17/03/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
| This clinical trial is being conducted to ascertain the efficacy and safety of test product on healthy human Indian volunteers suffering from hair greying problems in their early age. Volunteers will be enrolled basis on inclusion criteria mentioned in the protocol. Product usage instruction will be provided to volunteers at the initiation of the study. Safety and efficacy assessment will be done by the experts at regular period as per protocol. Assessment will be compared change form baseline value. | |