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CTRI Number  CTRI/2023/04/051903 [Registered on: 24/04/2023] Trial Registered Prospectively
Last Modified On: 23/04/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [PLATELET RICH PLASMA THERAPY]  
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   A study of diffuse hair loss in males & comparision of treatment modalities like PRP with minoxidil & finasteride 
Scientific Title of Study   To study the clinical profile of Androgenetic Alopecia in males & to compare the efficacy of PRP with minoxidil & finasteride 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrVK Garg 
Designation  Professor and Head of Department 
Affiliation  Santosh hospital and medical college 
Address  Department of dermatology ,Room no.211, second floor,santosh hospital,ambedkar road opp. old bus stand maliwara nehru nagar , Ghaziabad
SANTOSH NAGAR, PRATAP VIHAR
Gautam Buddha Nagar
UTTAR PRADESH
201001
India 
Phone  9968604367  
Fax    
Email  vijaykga@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DrVK Garg 
Designation  Professor and Head of Department 
Affiliation  Santosh hospital and medical college 
Address  Department of dermatology ,Room no.211, second floor,santosh hospital,ambedkar road opp. old bus stand maliwara nehru nagar , Ghaziabad
SANTOSH NAGAR, PRATAP VIHAR
Ghaziabad
UTTAR PRADESH
201001
India 
Phone  9968604367  
Fax    
Email  vijaykga@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Mehak Gupta 
Designation  Post Graduate student 2 
Affiliation  Santosh hospital and medical college 
Address  Department of dermatology ,Room no.214, second floor,santosh hospital,ambedkar road opp. old bus stand maliwara nehru nagar , Ghaziabad
SANTOSH NAGAR, PRATAP VIHAR
Ghaziabad
UTTAR PRADESH
201001
India 
Phone  9999880658  
Fax    
Email  mehak21gupta@gmail.com  
 
Source of Monetary or Material Support  
santosh medical college and hospital 1,Ambedkar road,Opposite old bus stand,maliwara,nehru nagar,Ghaziabad,Uttar Pradesh 201001 
 
Primary Sponsor  
Name  Santosh medical college and hospital 
Address  Santosh Nagar, Pratap Vihar 
Type of Sponsor  Private medical college 
 
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 VK Garg  santosh hospital  Department of dermatology ,Room no.211, second floor,santosh hospital,ambedkar road opp. old bus stand maliwara nehru nagar , Ghaziabad
Ghaziabad
UTTAR PRADESH 		 9968604367

vijaykga@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L649||Androgenic alopecia, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Normal saline  Normal saline is used as a placebo and injected (in scalp)in controls 
Intervention  Platelet rich plasma(PRP) therapy   PRP will be prepared from patients own blood using centrifugation machine.It will be injected intradermally over scalp in patients of this group monthly for 3 months. 
Intervention  Topical solution of 5% minoxidil and 0.1% finasteride  Patients in this group will be instructed to apply topical solution 1ml on dry scalp two times a day for 3 months 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Male 
Details  Patients within age group of 18-50 year, not using topical minoxidil and oral or topical finasteride for atleast 6 months, willing to come for regular follow up, platelet count> 1.5 lacs per microlitre of blood 
 
ExclusionCriteria 
Details  Uncooperstive patients, any dermatological disease of scalp, tendency to form keloid, patient is on anticoagulant therapy 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To find effectiveness of PRP  at end of 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
To compare between efficacy of PRP with minoxidil and finasteride solution  at end of 6 months 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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   N/A 
Date of First Enrollment (India)   27/04/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  27/04/2023 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Androgenetic alopecia  is a hereditary autosomal dominant, androgen- dependent disorder characterized by progressive, patterned hair loss from the scalp, and occurs in both men and women. Various treatment modalities have been tried. Combination of topical minoxidil and finasteride have shown some success. Recently, Platelet rich plasma which contains concentrated platelet and other growth factors have been used as adjuvant therapy. Because of paucity of literature of comparing various topical modalities prompted us to undertake the study to compare PRP combined with minoxidil and finasteride, PRP alone, minoxidil and finasteride topical solution alone and control. 
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