| CTRI Number |
CTRI/2025/06/088348 [Registered on: 06/06/2025] Trial Registered Prospectively |
| Last Modified On: |
02/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
USE OF VARIOUS BLOOD COMPONENTS FOR HAIR REGROWTH |
|
Scientific Title of Study
|
EVALUATING EFFICACY OF PLATELET RICH PLASMA, INJECTABLE PLATELET RICH FIBRIN AND GROWTH FACTOR CONCENTRATE ON PROMOTING HAIR REGROWTH: 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 Anvesha Priya |
| Designation |
Post Graduate Student |
| Affiliation |
Institute of Dental Sciences , Bareilly |
| Address |
ROOM NO. -110 , Department of Oral and Maxillofacial Surgery,Pilhibit Bypass Road, Opposite Suresh Sharma Nagar, Bareilly 243006
Pilhibit Bypass Road, Opposite Suresh Sharma Nagar, Bareilly 243006
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
9304904344 |
| Fax |
|
| Email |
anveshapriya49@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S Gokkulakrishnan |
| Designation |
Professor and HOD |
| Affiliation |
Institute of Dental Sciences , Bareilly |
| Address |
Room no. 110,Department of Oral and Maxillofacial Surgery Institute of Dental Sciences Campus,Pilhibit Bypass Road, Opposite Suresh Sharma Nagar, Bareilly 243006
Room no. 110,Department of Oral and Maxillofacial Surgery Institute of Dental Sciences Campus,Pilhibit Bypass Road, Opposite Suresh Sharma Nagar, Bareilly 243006
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
9360807874 |
| Fax |
|
| Email |
surgeondrgokkul@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr S Gokkulakrishnan |
| Designation |
Professor and HOD |
| Affiliation |
Institute of Dental Sciences , Bareilly |
| Address |
Room no. 110,Department of Oral and Maxillofacial Surgery Institute of Dental Sciences Campus,Pilhibit Bypass Road, Opposite Suresh Sharma Nagar, Bareilly 243006
Room no. 110,Department of Oral and Maxillofacial Surgery Institute of Dental Sciences Campus,Pilhibit Bypass Road, Opposite Suresh Sharma Nagar, Bareilly 243006
UTTAR PRADESH
243006
India |
| Phone |
9360807874 |
| Fax |
|
| Email |
surgeondrgokkul@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Institute of Dental Sciences , Bareilly |
| Address |
Pilhibhit Bypass Road , Suresh Sharma Nagar, Instituteod Dental Sciences , Bareilly |
| Type of Sponsor |
Other [Private Dental 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 |
| Dr Anvesha Priya |
Institute of dental sciences Bareilly |
Room no. -110 ,Department of Oral and Maxillofacial Surgery,Pilhibit Bypass Road, Suresh Sharma Nagar , Bareilly
Bareilly
UTTAR PRADESH |
9304904344
anveshapriya49@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee IDS Bareilly U.P. |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L988||Other specified disorders of the skin and subcutaneous tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
GFC |
Growth Factor Concentrate (GFC) is an advanced autologous therapy for hair regrowth. It involves processing the patient’s blood to extract and concentrate growth factors released from activated platelets (such as PDGF, VEGF, IGF, and EGF), which are then injected into the scalp. |
| Intervention |
IPRF |
Injectable Platelet-Rich Fibrin (iPRF) is an autologous blood product rich in platelets, leukocytes, and growth factors. When injected into the scalp, it promotes hair regrowth by stimulating hair follicles, improving blood supply, and prolonging the hair growth phase |
| Comparator Agent |
PRP |
Platelet-Rich Plasma (PRP) therapy uses a patients own blood, processed to concentrate platelets rich in growth factors. These are injected into the scalp to stimulate hair follicles, increase blood supply, and promote hair growth. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1. Individuals with androgenic alopecia.
2. Healthy adult individuals between18-45 years without any underlying medical conditions that may affect hair regrowth.
3. Patient with androgenic alopecia of vertex grade 1-5 of Hamilton Norwood12 or grade 1-2 of Ludwig scale13 without frontal baldness.
4. Person who has not taken any medical treatment for androgenic alopecia in any form in last 6 months .
5. Willing to give informed consent
|
|
| ExclusionCriteria |
| Details |
1. Individuals undergoing concurrent hair loss treatments.
2. Pregnant or lactating women.
3. Patient with any systemic disease or long-term medication.
4. Patients with any local pathology of hair inducing hair fall or undergoing treatment for the same .
5. History of hair transplant .
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| GFC is better than other blood components in Hair Regrowth |
1st, 3rd and 4th months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| GFC is better than other blood components in Hair Regrowth |
1st, 3rd and 4th months |
|
|
Target Sample Size
|
Total Sample Size="21"
Sample Size from India="21"
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)
|
15/06/2025 |
| 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="0"
Days="0" |
|
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 - NO
|
|
Brief Summary
|
Androgenic alopecia (AGA) is the most common form of hair loss, influenced by genetics and androgens like DHT.
It presents as patterned hair loss in men and diffuse thinning in women, known as Female Pattern Hair Loss (FPHL).
Conventional treatments include oral finasteride and topical minoxidil but may cause side effects and inconsistent results.
Hair transplants offer a solution but are expensive and may require multiple sessions.
Autologous platelet concentrates are gaining attention for their regenerative properties.
PRP (Platelet-Rich Plasma) is rich in growth factors that stimulate hair follicle activity and scalp regeneration.
iPRF (Injectable Platelet-Rich Fibrin) offers a more bioactive and sustained release of growth factors compared to PRP.
GFC (Growth Factor Concentrate) uses activated platelets to enhance vascularization and follicular repair.
These therapies aim to improve hair growth, density, and follicular health in AGA patients.
A comparative study is needed to determine which therapy is most effective, safe, and yields faster results. |