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CTRI Number  CTRI/2025/07/090550 [Registered on: 09/07/2025] Trial Registered Prospectively
Last Modified On: 09/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Vasa Ghrita NetraTarpan and Mahatriphaladi Ghrita NetraTarpan in the Treatment of Myopia for the improvement in vision 
Scientific Title of Study   Evaluation of Comparative Efficacy of Vasa Ghrita NetraTarpan versus Mahatriphaladi Ghrita NetraTarpan in the Management of Simple Myopia Timir Randomized controlled 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 Nishant Vishnu Farkade 
Designation  PG scholar 
Affiliation  Mahatma Gandhi Ayurved College Hospital and Research Center Salod Hirapur Wardha  
Address  Room no 24 Shalakyatantra OPD Mahatma Gandhi Ayurved College Hospital and Research Center Salod Hirapur Wardha Maharashtra India 442001

Wardha
MAHARASHTRA
442001
India 
Phone  9373440030  
Fax    
Email  nishantfarkade1899@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Roshna Rathi 
Designation  Professor 
Affiliation  Mahatma Gandhi Ayurveda College Hospital and Research Center Salod Wardha  
Address  Room no 24 Shalakyatantra OPD Mahatma Gandhi Ayurved College Hospital and Research Center Salod Hirapur Wardha Maharashtra India 442001

Wardha
MAHARASHTRA
442001
India 
Phone  8766866422  
Fax    
Email  roshna.bhutada@dmiher.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Roshna Rathi 
Designation  Professor 
Affiliation  Mahatma Gandhi Ayurveda College Hospital and Research Center Salod Wardha  
Address  Room no 24 Shalakyatantra OPD Mahatma Gandhi Ayurved College Hospital and Research Center Salod Hirapur Wardha Maharashtra India 442001

Wardha
MAHARASHTRA
442001
India 
Phone  8766866422  
Fax    
Email  roshna.bhutada@dmiher.edu.in  
 
Source of Monetary or Material Support  
Mahatma Gandhi Ayurveda College Hospital and Research Center Salod Wardha  
 
Primary Sponsor  
Name  Dr Nishant Vishnu Farkade 
Address  Room no 24 Shalakyatantra OPD Mahatma Gandhi Ayurved College Hospital and Research Center Salod Hirapur Wardha Maharashtra India 442001 
Type of Sponsor  Other [self] 
 
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 Nishant Vishnu Farkade  Mahatma Gandhi Ayurved College Hospital and Research Centre  Room no 24 Shalakyatantra OPD Mahatma Gandhi Ayurved College Hospital and Research Center Salod Hirapur Wardha Maharashtra India 442001
Wardha
MAHARASHTRA 		 9373440030

nishantfarkade1899@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:H521||Myopia. Ayurveda Condition: TIMIRAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Vasa Ghrita, Reference: Ashtang Hruday Chikitsa 2/42-43, Route: Topical, Dosage Form: Ghrita, Dose: 20(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 14 Days, anupAna/sahapAna: No, Additional Information: NetraTarpan Once a day for 7 days, then 15 days Parihar Kal, and then 7 days again NetraTarpan
2Comparator ArmDrugClassical(1) Medicine Name: Mahatrihaladi Ghrita , Reference: Ashtang Hruday Uttartantra 13/14, Route: Topical, Dosage Form: Ghrita, Dose: 20(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 14 Days, anupAna/sahapAna: No, Additional Information: NetraTarpan Once a day for 7 days, then 15 days Parihar Kal, and then 7 days again NetraTarpan
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  25.00 Year(s)
Gender  Both 
Details  Patients are willing to give informed consent
Patient age between 16 and 25 years
No History of major ocular or systemic disease
The patient is showing signs and symptoms of simple myopia as per Ayurveda
Modern spectacles -0.25 to -2.75 dioptres  
 
ExclusionCriteria 
Details  Patient with history of eye trauma and surgeries
Patient showing degenerative changes in posterior segment
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Improvement in Visual acuity by Snellen chart
Autorefractometer readings
 		 1 month
 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in Keratometry K1 K2
Improvement in A scan Axial length 		 1 month 
 
Target Sample Size   Total Sample Size="54"
Sample Size from India="54" 
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/ Phase 3 
Date of First Enrollment (India)   22/09/2025 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [nishantfarkade1899@gmail.com].

  6. For how long will this data be available start date provided 20-10-2026 and end date provided 20-10-2028?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Evaluation of Comparative Efficacy of Vasa Ghrita NetraTarpan versus Mahatriphaladi Ghrita NetraTarpan in the Management of Simple Myopia Timir Randomized controlled Trial
This study aims to compare the efficacy of Vasa Ghrita Netra Tarpan and Mahatriphaladi Ghrita Netra Tarpan in managing Simple Myopia Timir through a randomized controlled trial. It addresses the increasing prevalence of myopia and the limitations of conventional corrective lenses. The trial will include 54 patients aged 16–25 years divided into two groups receiving the respective treatments. Objective measures like visual acuity, refraction, keratometry, and axial length will be assessed. The goal is to find a safe cost-effective Ayurvedic alternative that may help control myopia progression.
 
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