| CTRI Number |
CTRI/2025/08/093644 [Registered on: 25/08/2025] Trial Registered Prospectively |
| Last Modified On: |
05/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Platelet Rich Plasma vs Minoxidil. Exploring effective treatments for Male pattern hair loss. |
|
Scientific Title of Study
|
Management of Androgenic Alopecia by either Platelet Rich Plasma or Minoxidil.A 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 Dheeraj Kumar |
| Designation |
PG student |
| Affiliation |
Kothiwal Dental College and Research Centre |
| Address |
Haridwar Road,Mohra Ki Milak,Moradabad,UTTAR PRADESH,Pincode 244001
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
7903167690 |
| Fax |
|
| Email |
ds979487@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gaurav Verma |
| Designation |
Professor |
| Affiliation |
Kothiwal Dental College and Research Centre |
| Address |
Haridwar Road,Mohra Ki Milak,Moradabad,UTTAR PRADESH,Pincode 244001
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
9736565635 |
| Fax |
|
| Email |
gauravjournals107@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dheeraj Kumar |
| Designation |
PG student |
| Affiliation |
Kothiwal Dental College and Research Centre |
| Address |
Haridwar Road,Mohra Ki Milak,Moradabad,UTTAR PRADESH,Pincode 244001
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
7903167690 |
| Fax |
|
| Email |
ds979487@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kothiwal Dental College and Research Centre, Haridwar road Mohra ki milak, MORADABAD, UTTAR PRADESH,PINCODE 244001,INDIA |
|
|
Primary Sponsor
|
| Name |
Dr Dheeraj Kumar |
| Address |
Kothiwal dental college and research centre, Moradabad,UTTAR PRADESH , Pincode 244001 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NIL |
NIL |
| NIL |
NIL |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Dheeraj Kumar |
Kothiwal Dental college and Research centre |
Kothiwal Dental College and Research Centre, Department of Oral and Maxillofacial Surgery,Room number two
Haridwar road,Mohra ki milak,MORADABAD,UTTAR PRADESH
Moradabad
UTTAR PRADESH |
7903167690
ds979487@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics and Review Board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Prevention trials |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Minoxidil |
One ml of minoxidil spray
Four times(once a day) at interval of 2 weeks. |
| Intervention |
Platelet Rich plasma |
Four sessions of Platelet Rich plasma at regular intervals of two weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Male |
| Details |
Patients diagnosed with ANDROGENIC ALOPECIA based on NORWOOD SCALE.
Patients categorised as ASA1 and ASA2 based on AMERICAN SOCIETY OF ANESTHESIOLOGIST.
Patients who are willing to use minoxidil as part of treatment. |
|
| ExclusionCriteria |
| Details |
Hematological disorder patients.
Malnourished patients.
Thyroid disorder patients.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Numerical scale (0-10),0 indicates not satisfied and 10 indicates highly satisfied.
5 means average.
|
The final evaluation will be conducted 12 weeks after the start of treatment. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Hair count noted at prefixed square area at each visit.
Subjective improvement with score 1 to 10,worst(1) to best (10). |
12 weeks after start of treatment. |
|
|
Target Sample Size
|
Total Sample Size="13"
Sample Size from India="13"
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 |
|
Date of First Enrollment (India)
|
25/08/2025 |
| 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="0"
Months="8"
Days="2" |
|
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [ds979487@gmail.com].
- For how long will this data be available start date provided 10-08-2025 and end date provided 30-07-2025?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
A randomized clinical trial comparing the efficacy and safety of Platelet Rich Plasma versus Minoxidil in treating ANDROGENIC ALOPECIA. Sample size of thirteen patients to be done in age group of eighteen to forty five years. Four sessions at two weeks interval prepared using a two spin centrifugation method and injected with a nappage technique. In Minoxidil group topical application once daily over twelve weeks. Final assessment at twelve weeks. Clinical assessment by hair count, trichosan, global photography and 60 seconds comb test. |