| CTRI Number |
CTRI/2019/05/019092 [Registered on: 13/05/2019] Trial Registered Prospectively |
| Last Modified On: |
12/05/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of platelet counts and activator in platelet rich plasma to help in growth of hair in male type baldness |
|
Scientific Title of Study
|
Effect of platelet counts and activator in platelet rich plasma (PRP) for the treatment of androgenetic alopecia. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shailesh Singh |
| Designation |
junior resident |
| Affiliation |
Institute of medical science BHU |
| Address |
department of dermatology and venereology institute of medical science banaras Hindu university varanasi
Mirzapur
UTTAR PRADESH
231304
India |
| Phone |
9451555609 |
| Fax |
|
| Email |
drshailesh000@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Satyendra Kumar Singh |
| Designation |
Professor |
| Affiliation |
Institute of Medical Sciences BHU |
| Address |
Department of Dermatology Venereology
Institute of Medical Sciences Banaras Hindu University Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
|
| Fax |
|
| Email |
drsatyendraderma@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shailesh Singh |
| Designation |
junior resident |
| Affiliation |
Institute of medical science BHU |
| Address |
department of dermatology, institute of medical science,banaras Hindu university varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9451555609 |
| Fax |
|
| Email |
drshailesh000@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of Medical Science Banaras Hindu University varanasi uttar pradesh |
|
|
Primary Sponsor
|
| Name |
Institute of Medical Science Banaras Hindu University |
| Address |
OPD 207 Department of dermatology and venereology |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Shailesh singh |
Sir sunder lal hospital, banaras hindu university, varanasi |
skin OPD room no. 207
Varanasi
UTTAR PRADESH |
9451555609
drshailesh000@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE 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 |
Platelet rich plasma with activator |
PRP will be prepared by collecting 18cc of fresh blood in sodium citrate containing vacutainer. The tube will rotated in a cectrifugation machine at 2200 revolutions per minutes. plasma will be collected in another test tube and underwent a second centrifugation at 3500 rpm for 10 minutes.the lower one third contain PRP with activator will injected in scal;p with the help of insulin syringe. |
| Comparator Agent |
PRP without activator |
PRP will be prepared by collecting 18cc of fresh blood in sodium citrate containing vacutainer. The tube will rotated in a cectrifugation machine at 2200 revolutions per minutes. plasma will be collected in another test tube and underwent a second centrifugation at 3500 rpm for 10 minutes.the lower one third contain PRP witout activator will injected in scal;p with the help of insulin syringe. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Male |
| Details |
Patient of androgenetic alopecia having Halminton norwood scale 2-5 |
|
| ExclusionCriteria |
| Details |
All the patient using topical minoxidil finasteride and systemic finasteride for at least 3 month
Patient not giving informed consent or unable to understand the protocol and uncooperative patients
any inflammation erythema or scaling over scalp
Patient who have history of malignancies platelet disorders anemia or bleeding disorder bone marrow aplasia uncontrolled diabetes sepsis and cancer
Patient who are known to be HIV hepatitis B or C positive or immunocompromised
Patients who have active skin disease or skin infection at the intended treatment area
Patients with a propensity for keloids
Patients on antiplatelet drug like aspirin or non steroidal anti inflammatory drugs
Patients taking drugs known to cause alopecia like anticoagulants beta blocker ACE inhibitors OCP valproic acid lithium etc |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate hair counts hair density hair thickness |
six months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Subjective assessment using questionaire |
six months |
|
|
Target Sample Size
|
Total Sample Size="82"
Sample Size from India="82"
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)
|
26/05/2019 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
article: Rai T, Singh SK. Role of folic acid supplementation
in reducing side effects of oral methotrexate in patients of psoriasis: A
study. Indian J Drugs Dermatol 2016;2:83-6.
Singh SK, Rai T. Relapse in psoriasis with two different tapering regimens of methotrexate: A randomized open-label
controlled study. Indian J Dermatol Venereol Leprol 2015;81:144-7.
Received: March, 2014. Accepted: September, 2014. Source of Support: Nil. Confl ict of Interest: None declared.
Rai T, Singh SK. Scanty, short scalp
hair along with keratotic papular lesions on the scalp of a
7-year-old boy. Indian Dermatol Online J 2014;5:360
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Androgenetic alopecia is a common chronic hair loss disorder, characterized by stepwise miniaturization of hair follicle, resulting from alteration in the hair cycle dynamics, leading to vellus transformation of terminal hair follicle. Diagnosis will be stablished by history, examination, dermoscopic features and grade according to Hamilton Norwood scale. base line platelet count have been done. PRP will be prepared by collecting 18cc of fresh blood in sodium citrate containing vacutainer. The tube will rotated in a cectrifugation machine at 2200 revolutions per minutes. plasma will be collected in another test tube and underwent a second centrifugation at 3500 rpm for 10 minutes.the lower one third contain PRP that will injected in scal;p with the help of insulin syringe. |