| CTRI Number |
CTRI/2025/01/079052 [Registered on: 20/01/2025] Trial Registered Prospectively |
| Last Modified On: |
04/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Topical treatment and nutritional supplements] |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
Public Title of Study
Modification(s)
|
A study to check the efficacy of a Traya regime in reducing or managing hair fall. |
|
Scientific Title of Study
|
A randomized, single-blinded, parallel, controlled clinical study to evaluate the efficacy and safety of a test regime in female subjects with hair fall. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| HAIR/THHG/2024-01 version 2.0 Dated 07 Jan 2025 |
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 |
Department of Hair Sciences,
327/15, 2nd Floor,
1st Main,
Cambridge Layout,
Bangalore
KARNATAKA
560008
India |
| Phone |
08040917253 |
| Fax |
|
| Email |
mukta.sachdev@msclinical.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ritambhara |
| Designation |
Director- Business and Operations |
| Affiliation |
MS Clinical Research Pvt Ltd |
| Address |
327/15, 1st Main Road
Cambridge layout, Ulsoor
Bangalore
KARNATAKA
560008
India |
| Phone |
08040917253 |
| Fax |
|
| Email |
ritambhara@msclinical.com |
|
Details of Contact Person
Public Query
|
| Name |
Sudhanthiran S |
| Designation |
Manager- Techno Commercial |
| Affiliation |
MS Clinical Research Pvt Ltd |
| Address |
327/15, 1st Main Road
Cambridge Layout
Ulsoor
327/15, 2nd Floor,
Bangalore
KARNATAKA
560008
India |
| Phone |
08040917253 |
| Fax |
|
| Email |
sudhan@msclinical.com |
|
|
Source of Monetary or Material Support
|
| Tatvartha Health Private Limited
C7/67, Fortune Hotel Galaxy Compound, GIDC
Vapi-396195, Gujrat |
|
Primary Sponsor
Modification(s)
|
| Name |
Tatvartha Health Private Limited |
| Address |
C7/67, Fortune Hotel Galaxy Compound, GIDC
Vapi-396195, Gujrat
|
| Type of Sponsor |
Other [Health and wellness] |
|
|
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. |
327/15, 1st Main Road
Cambridge Layout
Ulsoor
Bangalore
KARNATAKA |
08040917253
mukta.sachdev@msclinical.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ACE Independant Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Female subjects with female pattern hair loss |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo |
1 mL of the placebo will be applied on divided sections of the scalp using the graduated dropper at night. |
| Intervention |
Regime comprising Hair growth serum, hair oil, neutraceuticals |
Serum: 1 mL of the serum will be applied on the divided sections of the scalp using a graduated dropper per application at night.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1.Female Patients aged 18 to 45years with female pattern hair loss
2.Subjects willing to provide written informed consent, indicating that they thoroughly understand the purpose and procedures required for the study and are willing to participate in the study.
3.Patients willing to undergo shaving of a test area on the scalp and have a mark in the target area.
4.Patient’s willingness to maintain same hair length.
5.Patients with blood parameters within the normal range as per blood investigations.
|
|
| ExclusionCriteria |
| Details |
1.Clinically relevant abnormal physical findings which could interfere with the study; in particular, skin damage such as skin abrasion, actinic keratosis or any abnormal findings in the scalp.
2.Clinically significant dandruff.
3.Active unstable thyroid disease, including subjects on therapy for either hyperthyroidism or hypothyroidism unless their dose of thyroid medication has been stable for at least 3 months (self- declared).
4.Patients who had hair transplant surgery or hair weaving.
5.Patient who had light or laser treatment on the scalp.
6.History or evidence of hair loss other than Androgenetic Alopecia (e.g. due to auto-immune, endocrine, mechanical or infectious process or secondary to a scalp dermatological disorder).
7.Patients with active seborrheic dermatitis.
8.Clinically relevant abnormal laboratory values indicative of physical illness (self-declared).
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in hair fall, improvement in hair density and improvement in hair quality as per Dermatological assessment, Trichoscan® measurement and comb test when compared to placebo, different time points and baseline. |
Baseline, Month 2, month 4 and month 6. Each timepoint will have 2 visits. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| change in hair density by dermatological, Trichoscan evaluations, change in hair thickness, hair growth, hair thinning, hair fall by dermatological, instrumental evaluations. |
Baseline, month 2, month 4, month 6. Each time point will have 2 visits. |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
31/01/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Hair loss, also known
as alopecia, is a common issue among females, with prevalence rates varying
based on age, genetics, and underlying health conditions. This study is designed to evaluate the efficacy of a test
regime consisting of a test serum, ayurvedic supplements and dietary
modification in reducing hair fall in female subjects.
The study will be conducted over approximately 6 months and will include 9 visits. Dermatological evaluations, instrumental evaluations, digital imaging and subject self assessments will be performed at various time points to evaluate the efficacy of the test regime. |