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CTRI Number  CTRI/2026/01/101864 [Registered on: 23/01/2026] Trial Registered Prospectively
Last Modified On: 23/01/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Other (Specify) [Feasibility study]  
Study Design  Other 
Public Title of Study   Study for the Development of Guidelines and for Standardization of Tarpana and Putapaka Ayurvedic Eye Procedures and to evaluate the feasibility of procedure in Myopia 
Scientific Title of Study   A Clinical Consensus study for developing the practice guidelines and Standardization of Tarpana & Putapaka with a Feasibility study in Myopia 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Bhavya B M 
Designation  Research Officer (Ay.) 
Affiliation  Central Ayurveda Research Institute, Bengaluru 
Address  # 12, Uttarahalli Manavarthe Kaval, Uttarahalli (Hobli), Bangalore South (Tq.),Kanakapura Main Road, Talaghattapura post. Bengaluru
Administrative building, 1st floor, Room no. 103, Department of Shalakya Tantra, CARI, Bengaluru
Bangalore
KARNATAKA
560109
India 
Phone  9741748242  
Fax    
Email  drbhavya25@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Bhavya B M 
Designation  Research Officer (Ay.) 
Affiliation  Central Ayurveda Research Institute, Bengaluru 
Address  # 12, Uttarahalli Manavarthe Kaval, Uttarahalli (Hobli), Bangalore South (Tq.),Kanakapura Main Road, Talaghattapura post. Bengaluru
Administrative building, 1st floor, Room no. 103, Department of Shalakya Tantra, CARI, Bengaluru
Bangalore
KARNATAKA
560109
India 
Phone  9741748242  
Fax    
Email  drbhavya25@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Bhavya B M 
Designation  Research Officer (Ay.) 
Affiliation  Central Ayurveda Research Institute, Bengaluru 
Address  Administrative building, 1st floor, Room no. 103, Department of Shalakya Tantra, CARI, Bengaluru, # 12, Uttarahalli Manavarthe Kaval, Uttarahalli (Hobli), Bangalore South (Tq.),Kanakapura Main Road, Talaghattapura post. Bengaluru
Administrative building, 1st floor, Room no. 103, Department of Shalakya Tantra, CARI, Bengaluru
Bangalore
KARNATAKA
560109
India 
Phone  9741748242  
Fax    
Email  drbhavya25@gmail.com  
 
Source of Monetary or Material Support  
Central Council for Research in Ayurvedic Sciences (CCRAS), New Delhi, Ministry of Ayush, Govt of India 
 
Primary Sponsor  
Name  Central Council for Research in Ayurvedic Sciences CCRAS 
Address  Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan 61-65, Institutional Area, Opposite D- Block, Janakpuri, New Delhi- 110058 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 4  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Mata Shweta  Central Ayurveda Research Institute, West Panjabi bagh, New Delhi, Delhi  OPD Block, 2nd floor, Room no.201, ENT OPD. CARI, Road No. 66, Punjabi Bagh West, New Delhi- 110026
New Delhi
DELHI 
8866014946

drshwetamataccras@gmail.com 
Bhavya BM  Central Ayurveda Research Institute, Bengaluru  Administrative building, 1st floor, Room no. 103, Department of Shalakya Tantra, CARI, 12, Uttarahalli Manavartekaval, Thalaghattapura post, Kanakapura main road, Bengaluru 560109
Bangalore
KARNATAKA 
9741748242

drbhavya25@gmail.com 
Dr Krishnakumar V  National Ayurveda Research Institute for Panchakarma, Cheruthuruthy   OPD no.4, Ground floor, Hospital Block, Department of Shalakya Tantra, National Ayurveda Research Institute for Panchakarma, Cheruthuruthy, Thrissur, district, Kerala - 679531
Thrissur
KERALA 
7306892140

drkkempran@gmail.com 
Dr Kamble Pallavi Namdev   Regional Ayurveda Research Institute, Lucknow  Room no. 311, Hospital Block, Department of Shalakya Tantra, RARI, Sector 25, Indira Nagar, Lucknow - 226016
Lucknow
UTTAR PRADESH 
8955325835

drpallavikamble24@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 4  
Name of Committee  Approval Status 
Regional Ayurveda Research Institute, Lucknow  Approved 
Central Ayurveda Research Institute (CARI) Bengaluru  Approved 
Central Ayurveda Research Institute, West Panjabi bagh, New Delhi, Delhi  Approved 
National Ayurveda Research Institute for Panchakarma, Cheruthuruthy  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 ArmProcedure-netratarpaNam, नेत्रतर्पणम् (Procedure Reference: Sushruta and Astanga Samhita, Procedure details: Tarpana with mahatriphaladi ghrita for 5 days as per sop developed after consensus study)
(1) Medicine Name: Mahatriphaladi ghrita, Reference: AFI, Part I, 6:14, Pg.No. 85, Route: Ocular, Dosage Form: Ghrita, Dose: 30(ml), Frequency: od, Duration: 5 Days
2Intervention ArmProcedure-puTapAkaH, पुटपाकः (Procedure Reference: Sushruta and Astanga Samhita, Procedure details: Putapaka will be performed for 3 days after Tarpana procedure in all the participants for doing feasibility study)
(1) Medicine Name: Aja yakrita , Reference: Susjhruta and Astanga samhita, Route: Ocular, Dosage Form: Swaras/ Juice, Dose: 30(ml), Frequency: od, Duration: 3 Days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  1. Subjects of age 18-40 years
2. Subjects presenting with Avyakta Darshana or blurring of vision for distance
3. Subjects diagnosed with low to modest degrees of myopia (0 to minus 6 diopters)
4. Subjects who agree to participate in the study and submit a written informed consent form
5. Willing and able to participate for 9 days
 
 
ExclusionCriteria 
Details   
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The feasibility and acceptability of the standardized procedure of Tarpana and Putapaka assessed in terms of Procedure completion rate (Percentage of participation who successfully completed the procedure of Tarpana & Putapaka), Protocol adherence rate after care and Tolerability of procedures from Base line to   At Baseline and on 9th Day after Treatment 
 
Secondary Outcome  
Outcome  TimePoints 
Change in Best-corrected visual acuity (BCVA) on Snellen’s distant vision chart (At the baseline & on 9th day)
Any reporting of adverse event /ADR
Development of critical guidelines & standard operative procedures for Tarpana & Putapaka kriyakalpa procedure safety instructions, quality indicators, & feasibility.
 
Baseline (Before treatment) to Day 9 (after treatment) 
 
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   N/A 
Date of First Enrollment (India)   01/05/2026 
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="0"
Days="5" 
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  

Netra Kriyakalpa is a topical therapeutics performed in Ayurvedic ophthalmology. It involves a specific procedure using a prescribed formulation for proper application to the eyes. They comprise procedures such as Tarpana (retention of medicated ghee), Putapaka (retention of extracts of medicinal plants), Seka (medicated solution poured as stream), Aschyotana (eye drops), Anjana (ointments), Pindi and Bidalaka (external application on the eyelids and adnexa). Ayurveda certainly recommends a number of methodological guidelines that are specifically designed in accordance with the stage, site and severity of the disease in order to avoid any untoward effects and to obtain the optimum outcome. The Ocular therapeutics such as Tarpana and Putapaka mentioned in Ayurveda Samhita’s differs in factors such as dosage form, consistency of medicine temperature, retention time of medicines, the height of administration, safety instructions, quality indicators, and therapeutic benefit evaluation. Standardization is required to ensure uniformity in the quality and integrity of the procedures. Hence there is need of hour for development of critical guidelines for kriyakalpa procedures like Tarpana and Putapaka in terms of dosage form, temperature, time, height, quality, and feasibility in order to promote consistent practice.

This study is done in 2 stages, 

Stage 1 is Clinical consensus study to to develop standard operative procedure and practice guidelines for Tarpana & Putapaka kriyakalpa procedure using the RAND/UCLA Appropriateness Method (RAM) which is indeed a widely recognized technique used to assess the appropriateness of medical and surgical interventions. It involves gathering expert opinions through a structured process to evaluate the appropriateness of specific healthcare procedures or treatments. The method involves a panel of experts who independently review and rate the appropriateness of specific medical procedures. Their opinions are then aggregated and analyzed to provide insights into the appropriateness of those interventions. This information can be used to develop standardized practice guidelines, improve healthcare quality, and inform decision-making in clinical settings. In RAM, panellists rate the scenarios in a two-round “Modified Delphi” process. This method is a structured communication technique that involves a group of experts providing feedback in a series of rounds, with the goal of reaching a consensus. The "Modified" Delphi method usually involves iterative rounds of feedback and may include face-to-face interactions. The two-Round Rating Process includes, in the first round, panellists individually rate the appropriateness of medical procedures. There is no interaction among panellists during this phase. and in the second round, panel members come together for 1-2 days under the guidance of a moderator experienced in using the method. This face-to-face interaction allows for discussions and further clarification. 

     Stage 2 is the Feasibility study where Feasibility of Tarpana and Putapaka procedure with standardized dose, duration and procedure at OPD level, CARI, Bengaluru, CARI, New Delhi, RARI, Lucknow and NARIP, Cheruthuruthy (4 centres of CCRAS) is done with the objective to assess the feasibility and acceptability of the standardized procedure of Tarpana and Putapaka in in Myopia with Mahatriphaladya Ghrita. 


 
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