| CTRI Number |
CTRI/2025/02/080414 [Registered on: 12/02/2025] Trial Registered Prospectively |
| Last Modified On: |
09/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani
Diagnostic |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect Of Oil Amla Khas And Oil Hina With Drugs Like Shoneez And Mom In Androgenic Alopecia A Randomized Single Blind Controlled Trial |
|
Scientific Title of Study
|
Efficacy of Roghan Amla Khas versus Roghan Hina with Shoneez and Mom In Androgenic Alopecia (Sala) – A Randomized Single-Blind Comparative Clinical Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shaikh Zoya Rashid Ahmed |
| Designation |
PG scholar |
| Affiliation |
National Institute Of Unani Medicine |
| Address |
Department Of Amraze Jild Wa Tazeeniyat National Institute Of Unani Medicine Kottigepalya Magadi Main Road Bangalore 560091 Karnataka India
Bangalore
KARNATAKA
560091
India |
| Phone |
8169947793 |
| Fax |
|
| Email |
zoyashaheryar46@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof mohd Aleemuddin Quamri |
| Designation |
HOD Amraze Jild Wa Tazeeniyat & moalajat (i/c) |
| Affiliation |
National Institute Of Unani Medicine |
| Address |
Department Of Amraze Jild Wa Tazeeniyat Ic Moalajat National Institute Of Unani Medicine Kottigepalya Magadi Main Road Bangalore 560091 Karnataka India
Bangalore
KARNATAKA
560091
India |
| Phone |
9341072974 |
| Fax |
|
| Email |
drmaquamri@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof mohd Aleemuddin Quamri |
| Designation |
HOD Amraze Jild Wa Tazeeniyat & moalajat (i/c) |
| Affiliation |
National Institute Of Unani Medicine |
| Address |
Department Of Amraze Jild Wa Tazeeniyat Ic Moalajat National Institute Of Unani Medicine Kottigepalya Magadi Main Road Bangalore 560091 Karnataka India
Bangalore
KARNATAKA
560091
India |
| Phone |
9341072974 |
| Fax |
|
| Email |
drmaquamri@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute Of Unani Medicine |
|
|
Primary Sponsor
|
| Name |
National Institute Of Unani Medicine |
| Address |
Department Of Amraze Jild Wa Tazeeniyat National Institute Of Unani Medicine Kottigepalya Magadi Main Road Bangalore 560091 Karnataka India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Shaikh Zoya Rashid Ahmed |
National Institute Of Unani Medicine |
Department Of Amraze Jild Wa Tazeeniyat OPD/IPD ,National Institute Of Unani Medicine Kottigepalya Magadi Main Road Bangalore 560091 Karnataka India
Bangalore
KARNATAKA |
8169947793
zoyashaheryar46@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Communication of Decision of the Institutional Ethics Committee (IEC) for Biomedical Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L649||Androgenic alopecia, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Roghan Amla Khas |
10 ml of oil for Local application on the scalp with gentle massage daily twice a day. |
| Intervention |
Roghan Hina with Shoneez and Mom |
10 ml of oil for Local application on the scalp with gentle massage daily twice a day. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Male |
| Details |
1.Known Cases Of Androgenic Alopecia In Male Subject With Age 20-50 Years
2.Subjects With Grade I to IV AGA According To The Modified Norwood-Hamilton Scale |
|
| ExclusionCriteria |
| Details |
1.Subjects having diseases like scalp psoriasis, tinea capitis, Lichen Planopilaris, Trichotillomania, scarring alopecia, and alopecia areata
2.Subjects with history of CAM (complementary and alternative medicine) therapy or anti-androgenic medications or drugs causing hypertrichosis (phenytoin, acetazolamide, cyclosporine, diazoxide, psoralens, penicillamine, streptomycin and cortisone) or hypotrichosis (anti-coagulants, retinoids, lithium and beta blockers), use of finasteride or other 5-a reductase inhibitors or topical minoxidil within 01 month prior to enrolment
3.Subject with History of hair transplantation.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pharmacy-controlled Randomization |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| • Change in Trichoscopy Features (Hair shaft thickness heterogeneity, peripilar sign, follicular unit with single hair and yellow dots) |
0th Day,15th Day,30th Day, 45th Day,60th Day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
•Decrement in score of Patient Self Assessment Questionnaire
•Investigator Assessment Using Photography
•Decrement In score of Hair Specific Skindex-29
|
0th Day,15th Day,30th Day, 45th Day,60th Day |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
01/03/2025 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Objectives
of the study:
To
evaluate the comparative efficacy of Roghan Amla Khas versus Roghan
Hina with Shoneez and Mom in Androgenic alopecia (Sala).
Study
design: A Randomized Single Blind Comparative Clinical Trial
Interventions:
Topical drug in Group 1:Roghan Amla
Khas
Topical drug in Group 2:Roghan Hina
with Shoneez and Mom
Main Outcome Measures:
Primary endpoints
• Change
in Trichoscopy Features (Hair shaft thickness heterogeneity, peripilar
sign, follicular unit with single hair
and yellow dots)
Secondary Endpoint
• Decrement
in score of Patient Self Assessment Questionnaire
• Investigator
Assessment Using Photography
• Decrement
In score of Hair Specific Skindex-29
|