| CTRI Number |
CTRI/2022/06/043355 [Registered on: 20/06/2022] Trial Registered Prospectively |
| Last Modified On: |
08/05/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
To study the effect of Mintop shampoo in women with hairfall |
|
Scientific Title of Study
|
Consumer survey to evaluate the effects of Mintop Shampoo on hair, in women with hair fall. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CL/009/0422/STU Version No.: 1 of 19th April 2022 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rajiv Joshi |
| Designation |
Principal Investigator |
| Affiliation |
C.L.A.I.M.S. PVT.LTD |
| Address |
4th floor, B wing, Modi house, Dalia Industrial Estate, Andheri west.
Mumbai
MAHARASHTRA
400 058
India |
| Phone |
66758851 |
| Fax |
|
| Email |
rsjdrs@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rahul Rathod |
| Designation |
Head - Ideation and Clinical research |
| Affiliation |
Dr Reddys Laboratories Ltd |
| Address |
Medical Affairs Department,
Dr Reddys Laboratories Ltd,
7-1-27, Ameerpet
Hyderabad
TELANGANA
500016
India |
| Phone |
04049048400 |
| Fax |
|
| Email |
Rahul.Rathod@drreddys.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rahul Rathod |
| Designation |
Head - Ideation and Clinical research |
| Affiliation |
Dr Reddys Laboratories Ltd |
| Address |
Medical Affairs Department,
Dr Reddys Laboratories Ltd,
7-1-27, Ameerpet
Hyderabad
TELANGANA
500016
India |
| Phone |
04049048400 |
| Fax |
|
| Email |
Rahul.Rathod@drreddys.com |
|
|
Source of Monetary or Material Support
|
| Dr Reddys Laboratories Ltd |
|
|
Primary Sponsor
|
| Name |
Dr Reddys Laboratories Ltd |
| Address |
7-1-27, Greenlands, Ameerpet,
Hyderabad 500016 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Rajiv Joshi |
C.L.A.I.M.S. PVT.LTD. |
C-12, 4th floor, B wing, Modi house,Dalia Industrial Estate, Andheri west
Mumbai
MAHARASHTRA |
66758851
rsjdrs@gmail.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 with hairfall will be included in the study. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Mintop shampoo |
Approximately 5ml of shampoo will be applied and massaged on the wet scalp. It will be kept
for on hair for 2 – 3 mins. After this it will be rinsed with water. Product will be used thrice a week for 30 days.
|
| Comparator Agent |
None |
None |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Female |
| Details |
1.Voluntary women between 18 and 55 years of age.
2.Self-declared having hairfall.
3. Having dry and damaged hair.
4.Having signed a Consent Form.
5. Agreeing to use only shampoo provided by Sponsor. |
|
| 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 |
To evaluate the effects of Mintop Shampoo on hair, in women with hairfall by using a
consumer questionnaire.
|
Day 0, Day 30
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| None |
Nons |
|
|
Target Sample Size
|
Total Sample Size="165"
Sample Size from India="165"
Final Enrollment numbers achieved (Total)= "165"
Final Enrollment numbers achieved (India)="165" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
22/06/2022 |
| Date of Study Completion (India) |
16/08/2022 |
| 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
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Mintop shampoo is the test product and claims to help reduce hairfall, revitalize and strengthen hair. In this consumer survey we will be evaluating the effectiveness of Mintop shampoo on various parameters by using a consumer feedback questionnaire.
Results: The study was completed with 165 complete cases and No adverse events were reported during the study. |