| CTRI Number |
CTRI/2024/09/073415 [Registered on: 04/09/2024] Trial Registered Prospectively |
| Last Modified On: |
04/09/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Ayurvedic Proprietary Medicine] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of ayurvedic product on hair growth |
|
Scientific Title of Study
|
A clinical study to investigate anti hair fall efficacy of ayurvedic products |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| XXX-7I03-UV-JY24; Version: 02; Dated: 26/07/24 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pooja Yadav |
| Designation |
Principal Investigator |
| Affiliation |
MASCOT-SPINCONTROL India Pvt. Ltd. |
| Address |
Sea Breeze Building, 9th Floor,
AppaSaheb Marathe Marg,
Century Bazaar, Prabhadevi,
Mumbai, Maharashtra 400025, INDIA
Mumbai
MAHARASHTRA
400025
India |
| Phone |
02243349191 |
| Fax |
|
| Email |
investigators@mascotspincontrol.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pooja Yadav |
| Designation |
Principal Investigator |
| Affiliation |
MASCOT-SPINCONTROL India Pvt. Ltd. |
| Address |
Sea Breeze Building, 9th Floor,
AppaSaheb Marathe Marg,
Century Bazaar, Prabhadevi,
Mumbai, Maharashtra 400025, INDIA
MAHARASHTRA
400025
India |
| Phone |
02243349191 |
| Fax |
|
| Email |
investigators@mascotspincontrol.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mohit Lalvani |
| Designation |
Study Director |
| Affiliation |
MASCOT-SPINCONTROL India Pvt. Ltd. |
| Address |
Sea Breeze Building, 9th Floor,
AppaSaheb Marathe Marg,
Century Bazaar, Prabhadevi,
Mumbai, Maharashtra 400025, INDIA
Mumbai
MAHARASHTRA
400025
India |
| Phone |
02243349191 |
| Fax |
|
| Email |
mohit.CTRI@gmail.com |
|
|
Source of Monetary or Material Support
|
| Hindustan Unilever Pvt Limited
Unilever House, B.D. Sawant Marg, Chakala,
Mumbai- 400 099 |
|
|
Primary Sponsor
|
| Name |
Hindustan Unilever Pvt Limited |
| Address |
Unilever House, B.D. Sawant Marg, Chakala,
Mumbai- 400 099 |
| 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 Pooja Yadav |
Mascot Spincontrol India Pvt. Ltd. |
Sea Breeze Building, 9th Floor,
AppaSaheb Marathe Marg,
Century Bazaar, Prabhadevi,
Mumbai, Maharashtra 400025, INDIA
Mumbai
MAHARASHTRA |
02243349191
investigators@mascotspincontrol.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Suraksa- Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
FA-3, khÄlityam/khalati(Hair Fall) |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: MP41 (Ayurvedic Hair care Product), Reference: NA, Route: Topical, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 3(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: Everyday | | 2 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: JB65 (Ayurvedic Hair care Product), Reference: NA, Route: Topical, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 3(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: Everyday |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1)Healthy male and female volunteers between 20-45 years of age (including both ages)
2)Volunteer presenting mild hair fall to moderate hair fall.
3)Volunteers presenting hair thinning |
|
| ExclusionCriteria |
| Details |
1)Volunteer pregnant or planning to become pregnant.
2)Volunteers who are breastfeeding or having stopped to breastfeed in the past three months.
3)Volunteers with any other signs of significant local irritation, erythema or skin disease on scalp as well as on the visible parts of the body skin site.
4)Volunteers with self-perceived sensitive skin.
5)Volunteers having chronic illness or had major surgery in the last year.
6)Volunteers undergoing any treatment of any skin condition on body.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Significant improvement in hair growth, reduction in hair fall |
Baseline , Day 14, 1 Month, 2 Month, 3 Month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
NA |
|
|
Target Sample Size
|
Total Sample Size="48"
Sample Size from India="48"
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 |
|
Date of First Enrollment (India)
|
15/09/2024 |
| 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
|
Study will be conducted to assess the efficacy
of test product in imparting Hair growth benefits. After obtaining
Informed consent form and qualifying the inclusion and exclusion criteria,
subjects will be enrolled into the study. The subjects will undergo wash
out period. Post wash out period, test products will be dispensed to subjects.
Post base line assessment subjects will be instructed to use the product for 3 months. All evaluation assessments
will be done at different times – 2
week, 1 month, 2 months and 3 months. |