| CTRI Number |
CTRI/2025/02/080635 [Registered on: 17/02/2025] Trial Registered Prospectively |
| Last Modified On: |
28/05/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Other (Specify) [Cosmetics] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Safety & Efficacy of Avimee Herbals Nansyl in Hair Growth and hairfall |
|
Scientific Title of Study
|
A Clinical Study to Evaluate the Safety & Efficacy of Avimee Herbals Nansyl in Hair Growth and hairfall with Phototrichogram |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CCFT493 Version 1.0 dated 30 Jan 2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Robin Chugh |
| Designation |
Principal Investigator |
| Affiliation |
CCFT Laboratories |
| Address |
1st Floor room 3, Skin testing lab , CCFT laboratories, AR multispecialty hospital and research center, Delhi Road
Meerut
UTTAR PRADESH
250002
India |
| Phone |
9027285265 |
| Fax |
|
| Email |
robinderm25@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Puneet Mittal |
| Designation |
Clinical Research Consultant |
| Affiliation |
CCFT Laboratories |
| Address |
1st Floor room 3, Skin testing lab , CCFT laboratories, AR multispecialty hospital and research center, Delhi Road
Meerut
UTTAR PRADESH
250002
India |
| Phone |
8937015757 |
| Fax |
|
| Email |
puneetmittal@mgcts.org |
|
Details of Contact Person
Public Query
|
| Name |
Puneet Mittal |
| Designation |
Clinical Research Consultant |
| Affiliation |
CCFT Laboratories |
| Address |
1st Floor room 3, Skin testing lab , CCFT laboratories, AR multispecialty hospital and research center, Delhi Road
UTTAR PRADESH
250002
India |
| Phone |
8937015757 |
| Fax |
|
| Email |
puneetmittal@mgcts.org |
|
|
Source of Monetary or Material Support
|
| Avimee Herbals Pvt Ltd, B-2/27, Hoziwala Industrial Estate, Sachin Apparel Park SEZ., Sachin, Surat, Gujarat 394235 |
| CCFT Laboratories, 135, Punjabipura, Delhi Road, Meerut, India, 250002 |
|
|
Primary Sponsor
|
| Name |
Avimee Herbal Pvt. Ltd. |
| Address |
B-2/27, Hoziwala Industrial Estate, Sachin Apparel Park SEZ., Sachin, Surat, Gujarat 394235 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Not Applicable |
Not Applicable |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Robin Chugh |
CCFT laboratories |
AR multispecialty hospital and research center, 1st Floor room 3, Skin testing lab , CCFT laboratories, Delhi Road
Meerut
UTTAR PRADESH |
9027285265
robinderm25@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ARMHRC Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Not Applicable |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
Test Product- Nansyl |
Test Product: Nansyl , Dose: approx. 0.5 to 1 ml
with help of dropper on bald
area with gentle massage twice
a day. Duration: 56 days , Route of administration: Topical |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1.Indian / Asian female (16) and male(24) subjects with Stage 2 and 3.
2. Healthy subjects (no infectious and evolutive pathology which could make the subject vulnerable and stop the study, no pathology which could interfere with the study, no symptom in the process of an exploratory.
3. Between 18 and 45 years of Age.
4. Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar….)
|
|
| ExclusionCriteria |
| Details |
1.Being pregnant or breastfeeding or having stopped to breastfeed in
the past three months.
2.Having refused to give her assent by not signing the consent form.
3.Taking part in another study liable to interfere with this study.
4.Having a chronic dermatosis liable to modify the cutaneous
reactivity on the tested area.
5.Being insulin-dependent diabetic or non insulin-dependent diabetic
with a recent therapy (less than 6 months).
6.Having a progressive asthma (either under treatment or last fit in
the last 2 years)
7.Being epileptic
8.Having non stabilized thyroid problems (requirement of a stabilized
treatment for at least 6 months) Having cutaneous hypersensitivity
9.Having a diagnosed or highly probable allergy to one or several
compounds of the cosmetic products
10. Following a chronic or intermittent medicinal treatment
comprising any of the following products : aspirin-based products,
anti-inflammatories, anti-histamines, anti coagulants, 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
12.Having changed her cosmetic habits except those required by the
protocol in the 14 days preceding the start of the study on the
studied anatomic unit
13. Having applied a cosmetic product on the studied areas the first
day of the study (except the usual shampoo)
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Subject Global Assessment Questionnaire
2.HD Imaging
3.Phototrichoscan Assessment |
T0min, T2 days, T28 days ,T30 days, T54days, T56 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not Applicable |
Not Applicable |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
25/02/2025 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
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)
|
A single blind one group study multiple products study. The trial was conducted as per ICH E6 R2 Guidelines Below Assessment will be done for 86 days on 40 (24 for test product + 16 for comparator)Healthy Human Volunteers
A. Change in Hair growth, calculated as Subject’s assessment below: 1. Noticed first signs of hair growth 2. Noticed baby hairs or new hairs 3. Noticed darkening of scalp 4. Improvement in hair growth 5. Improvement in hair density 6. Noticed reduction in hair fall
B. Phototrichogram analysis 1. Change in Hair Density 2. Change in A-T Ratio 3. Change in Hair Thickness 4. Change in Percentage of Vellus Hair 5. Change in Percentage of Terminal Hair
Assessment Time: T0min, T+2 days, T+28 days ,T+30 days, T+56 days T+58 days, T+84 days and T+86 days |