| CTRI Number |
CTRI/2025/04/084150 [Registered on: 04/04/2025] Trial Registered Prospectively |
| Last Modified On: |
02/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Stem Cell Therapy
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Hair growth comparison between i-PRF and i-PRF with Aloe Vera |
|
Scientific Title of Study
|
Comparative Evaluation of Injectable Platelet-Rich Fibrin with and without Aloe Vera for Hair Retention and Growth in Androgenic Alopecia: A Pilot Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Murtaza Contractor |
| Designation |
Lead investigator |
| Affiliation |
Dr. D. Y. Patil Dental College and Hospital |
| Address |
Department of Oral and Maxillofacial Surgery, Dr. D. Y. Patil Dental College and Hospital, Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
918000009653 |
| Fax |
|
| Email |
mur7u.mc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Kalyani Bhate |
| Designation |
Lead investigator |
| Affiliation |
Dr. D. Y. Patil Dental College and Hospital |
| Address |
Department of Oral and Maxillofacial Surgery, Dr. D. Y. Patil Dental College and Hospital, Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
918000009653 |
| Fax |
|
| Email |
kalyani.bhate@dpu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Murtaza Contractor |
| Designation |
Lead investigator |
| Affiliation |
Dr. D. Y. Patil Dental College and Hospital |
| Address |
Department of Oral and Maxillofacial Surgery, Dr. D. Y. Patil Dental College and Hospital, Pimpri, Pune
MAHARASHTRA
411018
India |
| Phone |
918000009653 |
| Fax |
|
| Email |
mur7u.mc@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Murtaza Contractor |
| Address |
Department of Oral and Maxillofacial Surgery, Dr. D. Y. Patil Dental College and Hospital, Pimpri, Pune-411018 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 |
| Murtaza Contractor |
Dr. D. Y. Patil Dental College and Hospital |
Department of Oral and Maxillofacial Surgery, Dr. D. Y. Patil Dental College and Hospital, Pimpri, Pune
Pune
MAHARASHTRA |
0918000009653
mur7u.mc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Dr. D. Y. Patil Vidyapeeth, Pune |
Approved |
| Instituitional Stem Cell Comittee |
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 |
| Comparator Agent |
i-PRF alone |
here, the another half scalp will be treated with i-PRF alone. 2 ml i-PRF was injected subcutaneously on the scalp using insulin syringe. 4 subsequent sessions will be done at interval of 4 weeks. |
| Intervention |
i-PRF with Aloe Vera |
here, the half scalp will be treated with i-PRF along with adjunct Aloe Vera. 2 ml i-PRF was injected subcutaneously on the scalp using insulin syringe. Aloe Vera was applied locally at amount of 2 gm per session. 4 subsequent sessions will be done at interval of 4 weeks. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Male |
| Details |
Norwood Hamilton classifications III to V, and no history of hair restoration therapy in the preceding six months |
|
| ExclusionCriteria |
| Details |
Patients with active scalp infections, systemic diseases, or known hypersensitivity to Aloe Vera were excluded |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Hair growth in group where AloeVera is adjunct to i-PRF shpws better result than i-PRF alone |
outcome will be assessed at baseline and after 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| i-PRF with Aloe Vera will not show better result than i-PRF alone |
outcome wil be assessed after 12 weeks |
|
|
Target Sample Size
|
Total Sample Size="5"
Sample Size from India="5"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="25" |
|
Phase of Trial
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
20/04/2025 |
| Date of Study Completion (India) |
30/04/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
i-PRF has sown very promissing result in-vitro with increasing concentration in direct proportion. Aloe vera on the other hand showed that it needs an optimum concentration to get optimum outcomes. 100% pure aloevera showed cell death. so as per the optimum concentration achieved in an in-vitro study, aloevera is formulated and it is now checked in this in-vivo study with a split scalp method. |