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CTRI Number  CTRI/2025/03/082606 [Registered on: 18/03/2025] Trial Registered Prospectively
Last Modified On: 05/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Oral vs. Topical Minoxidil with PRP: A Revolutionary Trial for Androgenetic Alopecia 
Scientific Title of Study   Efficacy Of Oral Minoxidil Versus Topical Minoxidil in Androgenetic Alopcecia : A Randomised Control 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 Paridhi Vaidh 
Designation  Post Graduate Resident 
Affiliation  KALINGA INSTITUTE OF MEDICAL SCIENCES  
Address  Department of DVL, Kalinga institute of medical sciences ,Patia, Bhubaneshwar

Cuttack
ORISSA
751024
India 
Phone  9831055448  
Fax    
Email  drparidhivaidh@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Debasmita Behera  
Designation  Professor 
Affiliation  KALINGA INSTITUTE OF MEDICAL SCIENCES 
Address  Department of DVL, Kalinga institute of medical sciences,Patia, Bhubaneshwar

Cuttack
ORISSA
751024
India 
Phone  7008419784  
Fax    
Email  drdbehera427@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Chinmoy Raj  
Designation  Associate Professor  
Affiliation  KALINGA INSTITUTE OF MEDICAL SCIENCES 
Address  Department of DVL, Kalinga institute of medical sciences ,Patia, Bhubaneshwar

Cuttack
ORISSA
751024
India 
Phone  7008419784  
Fax    
Email  craj71285@gmail.com  
 
Source of Monetary or Material Support  
KALINGA INSTITUTE OF MEDICAL SCIENCES 
 
Primary Sponsor  
Name  Dr Paridhi Vaidh 
Address  Kalinga institute of medical sciences, khushabhadra campus,bhubneshwar  
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
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 Paridhi vaidh  Kalinga institute of medical science   Department of Dermatology, Kalinga institute of medical sciences, Patia, Bhubaneshwar
Cuttack
ORISSA 		 09831055448

drparidhivaidh@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
KALINGA INSTITUTE OF MEDICAL SCIENCES  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L64||Androgenic alopecia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Oral minoxidil + platelet rich plasma   2.5mg once daily oral minoxidil for 3 months and 3 sessions at monthly intervals of prp sesions will be planned.  
Comparator Agent  Topical Minoxidil 5% lotion + platelet rich plasma   Topical Minoxidil 5% twice daily for 3 months and 3 sessions at monthly intervals of prp sesions will be planned.  
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  45.00 Year(s)
Gender  Male 
Details  1. All consenting male patients aged 18-45 yrs.
2. All new clinically diagnosed cases with androgenetic alopecia of grade: III-VI according to Hamilton and Norwood classification
 
 
ExclusionCriteria 
Details  1.Patients with a history of Autoimmune disease and Severe systemic illness (such as uncontrolled DM or hypertension, liver or renal diseases, cardiovascular problems)
2.Any patients with known sleeping disorders.
3.Immunocompromised patients.
4.Patient with unrealistic expectations.
5.Alopecia caused by other factors such as telogen effluvium, alopecia areata, or scarring alopecia.
6.Patients who are positive for HIV/ HBsAg /HCV/ VDRL
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Oral minoxidil plus platelet rich plasma is considered superior to topical minoxidil plus platelet rich plasma for the treatment in terms of increase in hair density of males with androgenetic alopecia.  3 months 
 
Secondary Outcome  
Outcome  TimePoints 
1.Patient Satisfaction score
2.Dermatology life quality index  		 baseline , 3 months  
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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 4 
Date of First Enrollment (India)   18/03/2025 
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="1"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
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   All consenting male patients fulfiling the inclusion and exclusion criteria will be divided into 2 groups . group A - will recieve oral minoxidil 2.5mg once daily for 3 months along with platelet rich plasma and group B will recieve topical minoxidil twice daily 5% lotion plus platelet rich plasma for 3 months. 
total 3 sittings of platelet rich plsama will be planned for each group at monthly intervals. 
outcome assesment will be done on the basis of increase in hair density in terms of terminal and vellous hair in each treatment group at baseline , 4 , 8  12 weeks. along with patient satisfaction and dermatology life quality index at the baseline and 3 months  later. 
 
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