| CTRI Number |
CTRI/2025/02/080961 [Registered on: 20/02/2025] Trial Registered Prospectively |
| Last Modified On: |
08/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Role of Homoeopathic medicines in
the cases of male androgenetic alopecia |
|
Scientific Title of Study
|
Role of anti miasmatic medicines in
the cases of male androgenetic alopecia
in age group of 15-30 years
|
| 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 DIPALBEN HARSHADRAY RAVAL |
| Designation |
PG Scholar |
| Affiliation |
Smt A J Savla Homoeopathic Medical College and Research Institute |
| Address |
Department of medicine Room no 6 ground Floor Smt A J Savla Homoeopathic Medical College and Research Institute Pushpanjali Building Near District Session Court Mehsana
Mahesana
GUJARAT
384001
India |
| Phone |
8200619632 |
| Fax |
|
| Email |
drdipsraval12345@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR ANAND DESAI |
| Designation |
Professor |
| Affiliation |
Smt A J Savla Homoeopathic Medical College and Research Institute |
| Address |
Department of organon of medicine and homoeopathic philosophy room no 16 smt a j savla homoeopathic medical college and research institute pushpanjali building near district session court mehsana
Mahesana
GUJARAT
384001
India |
| Phone |
9429545666 |
| Fax |
|
| Email |
dranandjvb@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR DIPALBEN HARSHADRAY RAVAL |
| Designation |
PG Scholar |
| Affiliation |
Smt A J Savla Homoeopathic Medical College and Research Institute |
| Address |
Department of medicine Room no 6 ground Floor Smt A J Savla Homoeopathic Medical College and Research Institute Pushpanjali Building Near District Session Court Mehsana
Mahesana
GUJARAT
384001
India |
| Phone |
8200619632 |
| Fax |
|
| Email |
drdipsraval12345@gmail.com |
|
|
Source of Monetary or Material Support
|
| Smt A J Savla Homoeopathic Medical college and Research Institute Pushpanjali Building Near District Session Court Mehsana Gujarat 384001 |
|
|
Primary Sponsor
|
| Name |
DR DIPALBEN HARSHADRAY RAVAL |
| Address |
Department of medicine Room no 6 ground Floor Smt A J Savla Homoeopathic Medical College and Research Institute Pushpanjali Building Near District Session Court Mehsana |
| Type of Sponsor |
Other [self] |
|
|
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 DIPALBEN HARSHADRAY RAVAL |
Smt A J Savla Homoeopathic Medical college and Research Institute |
Department of medicine Room no 6 ground Floor Smt A J Savla Homoeopathic Medical College and Research Institute Pushpanjali Building Near District Session Court Mehsana
Mahesana
GUJARAT |
8200619632
drdipsraval12345@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Smt A J Savla Homoeopathic Medical College Institutional Ethical Committee |
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 |
| Intervention |
Antimiasmatic medicine |
Potency Various such as Centicimal Decimal 50 millesimal etc Doses as per need of cases Medicine will be Dispended as per potency Frequency as per Need of cases Route of administration oral Duration of Therapy up to 10 months as per the need of case |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Male |
| Details |
Already diagnosed case of androgenetic alopecia up to stage III baldness of Norwood- Hamilton classification
Patients who gives consent
Patients who are able and understand to fill HSS29 score
|
|
| ExclusionCriteria |
| Details |
Patients with scalp injury any scalp surgery
Patients with past and present history of scalp lichen planus history of chronic cutaneous lupus erythematosus involving scalp and scalp eczema scalp psoriasis and inflammatory tinea capitis
Patients with uncontrolled thyroid disease
Patients who have taken hormone replacement therapy within past 6 months Patients with existing malignancy and history of malignancy with in the past 5 years
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Androgenetic alopecia will be assessed with Trichoscopic examination |
Androgenetic alopecia will be assessed at baseline and end of treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessed by Hair Specific Skindex 29 Score |
assessed at baseline and end of treatment |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
03/03/2025 |
| Date of Study Completion (India) |
22/08/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
22/08/2025 |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| 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
|
THIS STUDY IS PROSPECTIVE STUDY PRE TEST POST TEST ONE GROUP EXPERIMENTAL STUDY TO ASSESS THE ROLE OF ANTI MIASMATIC MEDICINES FOR 10 MONTHS IN 40 PARTICIPANT WITH MALE ANDROGENETIC ALOPECIA THAT WILL BE CONDUCTED AS PER INCLUSION AND EXCLUSION CRITERIA FROM OUT PATIENT DEPARTMENT AND THE PRIMARY OUTCOME MEASURE ASSESSMENT WILL BE DONE ON CHANGES IN PARAMETERS OF TRICHOSCOPIC EXAMINATION IN BEFORE AND AFTER TRICHOSCOPIC IMAGES OF SAME ARIA AND SECONDARY OUTCOME ASSESSED WITH REDUCTION OF HAIR SPECIFIC SKINDEX 29 SCORE AT BASELINE AND AFTER 10 MONTHS OF TREATMENT FOLLOW UP AS PER NEED OF CASE FOR 10 MONTH OF DURATION |