| CTRI Number |
CTRI/2024/08/072440 [Registered on: 13/08/2024] Trial Registered Prospectively |
| Last Modified On: |
07/08/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cosmeceuitcal] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of product on hair fall and dandruff |
|
Scientific Title of Study
|
To evaluate the in-vivo safety and efficacy of Hair care formulation in terms of reduction in hair fall and reduction in dandruff on healthy human subjects. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| XXX-7I04-PI-JY24; Version: 01; Dated: 18/07/2024 |
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
Mumbai
MAHARASHTRA
400025
India |
| Phone |
002243349191 |
| Fax |
|
| Email |
poojayadav@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
MAHARASHTRA
400025
India |
| Phone |
002243349191 |
| Fax |
|
| Email |
poojayadav@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
Mumbai
MAHARASHTRA
400025
India |
| Phone |
02243349191 |
| Fax |
|
| Email |
mohit.CTRI@gmail.com |
|
|
Source of Monetary or Material Support
|
| Patanjali Ayurved Limited,
Unit III-Patanjali Food & Herbal Park,
Vill-Padartha, Haridwar-Laksar Road,
Haridwar-249404, Uttarakhand, India.
Telephone: 01334-265370 |
|
|
Primary Sponsor
|
| Name |
Patanjali Ayurved Limited |
| Address |
Unit III-Patanjali Food & Herbal Park,
Vill-Padartha, Haridwar-Laksar Road,
Haridwar-249404, Uttarakhand, India.
Telephone: 01334-265370 |
| 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
Mumbai
MAHARASHTRA |
02243349191
poojayadav@mascotspincontrol.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethos- An Institutional Ethics committee (Mumbai) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
having moderate to severe hair fall and dandruff |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
NA |
| Intervention |
Patanjali Onion Hair Oil |
Product is applied on whole scalp and shafts, thrice in a week for the period of 28 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
1.Asian Indian male & female subjects.
2.Healthy subjects
3.Skin is healthy on the studied anatomic unit.
4.Having moderate to severe hair fall and dandruff.
|
|
| ExclusionCriteria |
| Details |
1. For female: Being pregnant or breastfeeding or having stopped to breastfeed in the past three
months
2. Having refused to give his/her assent by not signing the consent form
3. Taking part in another study liable to interfere with this study4. Being insulin-dependent diabetic or non-insulin-dependent diabetic with a recent therapy (less than 6 months)
5. Having a progressive asthma (either under treatment or last fit in the last 2 years)
6. Being epileptic.
7. Having non stabilized thyroid problems (requirement of a stabilized treatment for at least 6 months)
8. Having cutaneous hypersensitivity
9. Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products.
10. Following a chronic medicinal treatment comprising any of the following products: aspirin-based products, anti-inflammatories, anti-histamines, corticotherapy, taken by general or local routes (the only medication permitted is paracetamol)
11. Having undergone a surgery requiring a general anaesthetic of more than one hour in the past 6 months. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in hair fall and reduction in dandruff |
Baseline, Day 14 and Day 28 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
NA |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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
|
N/A |
|
Date of First Enrollment (India)
|
18/08/2024 |
| 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="3"
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
|
OBJECTIVE:
The objective of this study will be to evaluate the in-vivo safety and efficacy
of Hair care formulation in terms of reduction in hair fall and reduction in
dandruff on healthy human subjects
The
evaluation will be performed using: Subject’s Self Evaluation, Dermatological
Evaluation: Cosmetic Acceptability, Dermatological Evaluation: Efficacy, Counting
of fallen hair after standardized combing, Photographs of Scalp build-up by
Denolite
The study
lasts 42 days including the 14 days conditioning phase and 28 days treatment
phase.
POPULATION:
36 (18 male & 18 female) subjects will be selected for the study.
The
subjects selected for this study will be healthy human subjects, aged between 18
and 35 years, having moderate to severe hair fall and dandruff |