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CTRI Number  CTRI/2024/12/077658 [Registered on: 04/12/2024] Trial Registered Prospectively
Last Modified On: 11/03/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Triphala Ghrita Tarpana versus Carboxymethylcellulose eye drop in Shushkakshipaka (Evaporative Dry eye due to Meibomian Gland Dysfunction) 
Scientific Title of Study   Randomized control trial of Triphala Ghrita Tarpana versus Carboxymethylcellulose eye drop in Shushkakshipaka (Evaporative Dry eye due to Meibomian Gland Dysfunction): 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  Ayushi Lohi 
Designation  Intern 
Affiliation  MGACH AND RC SALOD WARDHA 
Address  Room No 63 Shalakya Tantra OPD Mahatma Gandhi Ayurved Hospital Salod H Wardha

Wardha
MAHARASHTRA
422001
India 
Phone  9665808074  
Fax    
Email  lohiayushi9@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Piyush Pardhekar 
Designation  Assistant Professor, Department of Shalakya Tantra  
Affiliation  MGACH AND RC SALOD WARDHA 
Address  Room No. 63 Shalakya Tantra OPD Mahatma Gandhi Ayurved Hospital Salod H Wardha

Wardha
MAHARASHTRA
422001
India 
Phone  9359744087  
Fax    
Email  piyushpardhekar20@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Piyush Pardhekar 
Designation  Assistant professor Department of Shalakyatantra 
Affiliation  MGACH AND RC SALOD WARDHA 
Address  Room No. 63 Shalakya Tantra OPD Mahatma Gandhi Ayurved Hospital Salod H Wardha

Wardha
MAHARASHTRA
422001
India 
Phone  9359744087  
Fax    
Email  piyushpardhekar20@gmail.com  
 
Source of Monetary or Material Support  
Mahatma Gandhi Ayurved College Hospital and Research Centre Salod Hirapur Wardha, Maharashtra,India. 442001 
 
Primary Sponsor  
Name  Ayushi Lohi 
Address  Mahatma Gandhi Ayurved College Hospital and Research centre 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 Piyush Pardhekar  Mahatma Gandhi Ayurved Hospital Salod H Wardha  Room No 63 Shalakya Tantra OPD
Wardha
MAHARASHTRA 		 9359744087

piyushpardhekar20@gmail.com 
 
Details of Ethics Committee
Modification(s)  
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:H578||Other specified disorders of eye and adnexa. Ayurveda Condition: SARVAGATAKSHIROGAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-tarpana (Procedure Reference: sushruta uttartantra 18, Procedure details: tarpana used topically for 10 min for 7 days )
(1) Medicine Name: triphala ghrita, Reference: bhaishajya ratnavali 64, Route: Topical, Dosage Form: Ghrita, Dose: 20(ml), Frequency: od, Duration: 7 Days
2Comparator Arm (Non Ayurveda)-carboxymethylcellulose 0.5% eye dropCarboxymethylcellulose 0.5% eye drop used one drop four times a day topically, for 7 days
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Ocular surface disease index (OSDI) greater than and equal to 13 including lid margin changes and decreased meibum quality and quantity, irrespective of sex caste religion and socioeconomic status
Participants of both genders aged between 20 and 60 years
Tear film break-up time less than 10 seconds Schirmer-I test less than 10 mm
 
 
ExclusionCriteria 
Details  Active ocular infection ocular inflammatory disease or aqueous-deficient dry eye Schirmer test value of less than 5 mm 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Improvements in Tear film stability   Improvements in Tear film stability in 7 days 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in Ocular Surface Disease Index (OSDI)   Improvement in Ocular Surface Disease Index (OSDI) in 7 days 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   27/12/2024 
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="2"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details
Modification(s)  		 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-identiļ¬cation.

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

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  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 [piyushpardhekar20@gmail.com].

  6. For how long will this data be available start date provided 28-02-2025 and end date provided 13-01-2030?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary
Modification(s)  

This study is a Randomized control trial of Triphala Ghrita Tarpana versus Carboxymethylcellulose eye drop in Shushkakshipaka (Evaporative Dry eye due to Meibomian Gland Dysfunction): A Pilot study. The trial drug Triphala Ghrita Tarpana will be used topically for 10 minutes for 7 days, and the control drug Carboxymethylcellulose eye drop 0.5% will be used topically with one drop four times a day for 7 days. The primary outcome will be an improvement in tear film stability in 7 days, and the secondary outcome will be an improvement in the ocular surface disease index (OSDI) in 7 days, which will be measured before and after the completion of the treatment duration.

 
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