| CTRI Number |
CTRI/2024/11/076531 [Registered on: 11/11/2024] Trial Registered Prospectively |
| Last Modified On: |
09/11/2024 |
| 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 Jeena Sikho Shuddhi Dr. Hair oil |
|
Scientific Title of Study
|
A Clinical Study to Evaluate the Safety & Efficacy of Jeena Sikho Shuddhi Dr. Hair oil in Hair Growth and hairfall with Phototrichogram |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CCFT392 Version 1.0 dated 30 Oct 2024 |
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 |
09027285265 |
| 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
Meerut
UTTAR PRADESH
250002
India |
| Phone |
8937015757 |
| Fax |
|
| Email |
puneetmittal@mgcts.org |
|
|
Source of Monetary or Material Support
|
| CCFT Laboratories, 135, Punjabipura, Delhi Road, Meerut, India |
| Jeena Sikho Lifcare Ltd, Sco-11, Kalgidhar Enclave,Zirakpur, Chandigarh-140603 |
|
|
Primary Sponsor
|
| Name |
Jeena Sikho Lifcare Ltd |
| Address |
Sco-11, Kalgidhar Enclave,Zirakpur, Chandigarh-140603 |
| 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 |
1st Floor room 3, Skin testing lab , CCFT laboratories, AR multispecialty hospital and research center, Delhi Road
Meerut
UTTAR PRADESH |
09027285265
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 |
| Intervention |
Hair Growth Oil |
Test Product: Jeena Sikho Shuddhi Dr. Hair Oil, Dose: approx. 0.5 to 1 ml
with help of dropper on bald
area with gentle massage twice
a day. Duration: 84 Days, Route
of administration: Topical |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1. Voluntary man or women between 20 and 40 years.
2. Photo type III to V.
3. Having apparently healthy skin on test area
4. For whom the investigator considers that the compliance will be correct.
5. Cooperating, informed of the need and duration of the examinations and ready to comply with protocol procedures.
6. Having signed a Consent Form.
7. Should be able to read and write (in English, Hindi or local language).
8. Having valid proof of identity and age. |
|
| 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.SGA (Subject Global Assessment)
Questionnaire
2.HD Imaging
3.Phototrichoscan Assessment |
T0min, T+2 days, T+28 days ,T+30 days, T+56
days
T+58 days, T+84 days and T+86 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not Applicable |
Not Applicable |
|
|
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
20/11/2024 |
| 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
|
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 84 days on 36 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 |