| CTRI Number |
CTRI/2023/10/058846 [Registered on: 18/10/2023] Trial Registered Prospectively |
| Last Modified On: |
23/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cosmetic] |
| Study Design |
Other |
|
Public Title of Study
|
To study the effects of a serum in reducing hairfall in humans. |
|
Scientific Title of Study
|
Consumer survey to evaluate the effects of Mintop Serum in management of hair fall. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CL/068/0723/STU Version No.: 1 of 01 Aug 2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anjali Salvi |
| Designation |
Principal Investigator |
| Affiliation |
C.L.A.I.M.S. Pvt. Ltd. |
| Address |
5th floor, 27 MIDC, 17th road, MIDC Commercial Premises, Andheri East
Mumbai
MAHARASHTRA
400093
India |
| Phone |
66758851 |
| Fax |
|
| Email |
dranjali@claimsclinical.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ms Preetha Paul |
| Designation |
Senior Manager - TQM |
| Affiliation |
C.L.A.I.M.S. Pvt. Ltd. |
| Address |
5th floor, 27 MIDC, 17th road, MIDC Commercial Premises, Andheri East
Mumbai
MAHARASHTRA
400093
India |
| Phone |
66758851 |
| Fax |
|
| Email |
preetha@claimsclinical.com |
|
Details of Contact Person
Public Query
|
| Name |
Ms Preetha Paul |
| Designation |
Senior Manager - TQM |
| Affiliation |
C.L.A.I.M.S. Pvt. Ltd. |
| Address |
5th floor, 27 MIDC, 17th road, MIDC Commercial Premises, Andheri East
Mumbai
MAHARASHTRA
400093
India |
| Phone |
66758851 |
| Fax |
|
| Email |
preetha@claimsclinical.com |
|
|
Source of Monetary or Material Support
|
| Dr. Reddys Laboratories Ltd.,
7-1-27, Ameerpet
Hyderabad 500016, India |
|
|
Primary Sponsor
|
| Name |
Dr. Reddys Laboratories Ltd., |
| Address |
7-1-27, Ameerpet
Hyderabad 500016, India |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
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 Anjali Salvi |
C.L.A.I.M.S. Pvt. Ltd. |
Room No: 103, 1st Floor, C Wing, Shiv Krupa, S.R.A. CHS Ltd, Panam Park, Off Sahar Road, Vile Parle East
Mumbai
MAHARASHTRA |
66758851
dranjali@claimsclinical.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Independent Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy human volunteers complaining of hair fall will be included in the study. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Mintop Serum |
Approximately 1ml of Mintop serum will be applied and massaged on the scalp and hair twicedaily for 3 months. |
| Comparator Agent |
Not applicable |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Female |
| Details |
1. Women between 18 and 55 years (inclusive) of age willing to participate voluntarily.
2. Participants having self-declared hair fall (confirmed by hair pull test).
3. Participants who are able to understand written and/or verbal instructions and are ready
to comply with all survey requirements with a willingness to participate and ready to give
written informed consent voluntarily. Agreeing to use only test product (Mintop serum)
provided by Sponsor for hair fall management. |
|
| ExclusionCriteria |
| Details |
1. Allergic to any cosmetic product.
2. Pregnant women or lactating mothers.
3. Any clinical hair condition for which treatment is being taken.
4. History of thyroid, anaemia or hormonal problems
5. Participants who had Covid infection during the past 6 months.
6. Participants who had fever and prolonged illness recently. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Evaluation of Reduction in hair fall by Consumer questionnaire, hair pull test and 1 min comb test. |
Baseline, 1 month, 3 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| None |
None |
|
|
Target Sample Size
|
Total Sample Size="165"
Sample Size from India="165"
Final Enrollment numbers achieved (Total)= "161"
Final Enrollment numbers achieved (India)="161" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
26/10/2023 |
| Date of Study Completion (India) |
07/02/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
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
Modification(s)
|
Mintop serum is a test product and claims to help hair growth. In this consumer survey the effectiveness of Mintop serum on various hair parameters will be evaluated by using a consumer feedback questionnaire.
Results: The study was completed with 161 complete cases and no adverse events were reported during the study. |