| CTRI Number |
CTRI/2025/02/081126 [Registered on: 21/02/2025] Trial Registered Prospectively |
| Last Modified On: |
21/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Efficacy of Low Level Laser
Therapy on Hair Growth in Alopecia |
|
Scientific Title of Study
|
Efficacy of Low Level Laser
Therapy on Hair Growth in Alopecia |
| 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 Aashish yadav PT |
| Designation |
Ph.D Scholar |
| Affiliation |
Amity Institute of Physiotherapy |
| Address |
Amity Institute of Physiotherapy F1 Block Lower Floor Amity University Sector 125 Noida
Amity Institute of Physiotherapy F1 Block Lower Floor Amity University Sector 125 Noida
Gautam Buddha Nagar
UTTAR PRADESH
201313
India |
| Phone |
07011802921 |
| Fax |
|
| Email |
aashishyadav.ajipt20@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjib Kumar Das |
| Designation |
Associate Professor |
| Affiliation |
Amity Institute of Health and Allied Sciences |
| Address |
Faculty room Amity Institute of Physiotherapy F1 Block Lower Floor Amity University Sector 125 Noida
Faculty room Amity Institute of Physiotherapy F1 Block Lower Floor Amity University Sector 125 Noida
Gautam Buddha Nagar
UTTAR PRADESH
201313
India |
| Phone |
8879485847 |
| Fax |
|
| Email |
skdas@amity.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aashish yadav PT |
| Designation |
Ph.D Scholar |
| Affiliation |
Amity Institute of Physiotherapy |
| Address |
Amity Institute of Physiotherapy F1 Block Lower Floor Amity University Sector 125 Noida
Amity Institute of Physiotherapy F1 Block Lower Floor Amity University Sector 125 Noida
Gautam Buddha Nagar
UTTAR PRADESH
201313
India |
| Phone |
07011802921 |
| Fax |
|
| Email |
aashishyadav.ajipt20@gmail.com |
|
|
Source of Monetary or Material Support
|
| Amity Physiotherapy Department F1 Block Lower Floor Amity University Sector 125 Noida |
|
|
Primary Sponsor
|
| Name |
Dr Aashish yadav PT |
| Address |
Amity Institute of Physiotherapy F1 Block Lower Floor Amity University Sector 125 Noida |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Aashish yadav PT |
Amity Institute of Physiotherapy |
Amity Institute of Physiotherapy F1 Block Lower Floor Amity University Sector 125 Noida
Gautam Buddha Nagar
UTTAR PRADESH |
7011802921
aashishyadav.ajipt20@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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L648||Other androgenic alopecia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
LOW LEVEL LASER THERAPY |
Total duration of Intervention is 6 weeks Low level pulsed infrared diode laser of 830nm wavelength and 5000 Hz frequency with a power output of 90 mW will be used
Each subject will receive 3 sessions per week ( day after day) for 6 weeks
|
| Comparator Agent |
NOT AVAILABLE |
NOT AVAILABLE |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed cases of Androgenetic Alopecia
Age more than 20 years
Patients who have used topical, intra-lesional, or
systemic therapies for Alopecia, have no visual
evidence of new hair growth within the last 6
months |
|
| ExclusionCriteria |
| Details |
Any patient suffering from Alopecia in eye brow beard and moustache
Who have hair disorders other than Androgenetic or AA or systemic diseases that might affect the results
Pregnant or lactating women
Any history of uncontrolled bacterial viral fungal atypical mycobacterial or opportunistic infection
Patient with history of LLLT in their previous treatment |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Hair Diameter
Hair count
|
Base line and 6th week
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Hair Count
Hair Diameter |
At Baseline
At 10 weeks |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
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)
|
10/03/2025 |
| 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="0"
Months="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) - THROUGH PUBLICATION
- For how long will this data be available start date provided 01-11-2025 and end date provided 01-01-2030?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NOT APPLICABLE
|
|
Brief Summary
|
Data collection will be started after CTRI registration. |