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
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
(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
2
Intervention Arm
Procedure
-
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(retentionofmedicated ghee),Putapaka(retentionofextractsofmedicinalplants), 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 arespecificallydesigned in accordancewith the stage, site and severityof thedisease 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 todevelopstandardoperativeprocedureandpracticeguidelinesforTarpana&Putapakakriyakalpa procedure using theRAND/UCLAAppropriatenessMethod(RAM) which isindeedawidelyrecognizedtechniqueusedtoassess
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 techniquethat involves a group ofexperts providing feedback in a series ofrounds, 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-RoundRatingProcess 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 furtherclarification.
Stage 2 is the Feasibility study where FeasibilityofTarpanaandPutapaka procedure withstandardizeddose,durationandprocedureatOPDlevel, CARI, Bengaluru, CARI, New Delhi, RARI, Lucknow and NARIP, Cheruthuruthy (4 centres of CCRAS) is done with the objective toassessthefeasibilityandacceptabilityofthestandardizedprocedureofTarpanaand Putapaka in in Myopia with Mahatriphaladya Ghrita.