| CTRI Number |
CTRI/2026/04/109007 [Registered on: 21/04/2026] Trial Registered Prospectively |
| Last Modified On: |
18/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effectiveness of chakshushya basti in Nearsightedness |
|
Scientific Title of Study
|
Randomized control clinical trial of Chakshushya basti in pratham patalgat timir with special reference to Myopia |
| 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 Ajinkya Kondekar |
| Designation |
PhD Scholar |
| Affiliation |
Shri Annasaheb Dange Ayurvedic Medical Collage and Post Graduate Research Institute, Ashta |
| Address |
Department of Panchakarma, Shri Annasaheb Dange Ayurvedic Medical Collage and Post Graduate Research Institute, Ashta
Sangli
MAHARASHTRA
416301
India |
| Phone |
9766666728 |
| Fax |
|
| Email |
ajinkya01@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ajinkya Kondekar |
| Designation |
PhD Scholar |
| Affiliation |
Shri Annasaheb Dange Ayurvedic Medical Collage and Post Graduate Research Institute, Ashta |
| Address |
Department of Panchakarma, Shri Annasaheb Dange Ayurvedic Medical Collage and Post Graduate Research Institute, Ashta
Sangli
MAHARASHTRA
416301
India |
| Phone |
9766666728 |
| Fax |
|
| Email |
ajinkya01@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Alaknanda Kulkarni |
| Designation |
Professor & HOD |
| Affiliation |
Shri Annasaheb Dange Ayurvedic Medical Collage and Post Graduate Research Institute |
| Address |
Department of Panchakarma,
Shri Annasaheb Dange Ayurvedic Medical Collage and Post Graduate Research Institute, Ashta
Sangli
MAHARASHTRA
416301
India |
| Phone |
9860359489 |
| Fax |
|
| Email |
vdalknandakulkarni@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dhanvantari Ayurved Hospital, Ashta affilated To ADAMC Ashta, Tal Walwa,Dist- Sangli,State- Maharashra, Country-India,PIN-416301 |
| Dr J J Magdum Ayurved Medical Collage and Hospital, Jaysingpur,
A/P-jaysingpur,Tal- Shiril, Dist- Kolhapur,State- Maharashtra,Country-India, PIN- 416101 |
|
|
Primary Sponsor
|
| Name |
Dr Ajinkya Kondekar |
| Address |
Hon. Shri. Annasaheb Dange Ayurved Medical College, Post Graduate & Research Center,Ashta, Tal- Walwa,Dist- Sangli,State- Maharashra, Country-India,PIN-416301 |
| Type of Sponsor |
Other [Self Sponsored] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Alaknanda Kulkarni |
Dhanvantari Hospital, Ashta |
A/P- Ashta, Tal- Walwa, Dist- Sangli
Sangli
MAHARASHTRA |
9860359489
vdalknandakulkarni@gmail.com |
| Dr Ajinkya Kondekar |
Dr JJ Magdum Ayurved Medical College and Hospital |
Jaysingpur,Tal-Shirol, Dist-Kolhapur
Kolhapur
MAHARASHTRA |
9766666728
ajinkya01@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H521||Myopia. Ayurveda Condition: TIMIRAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | netratarpaNam, नेत्रतर्पणम् | (Procedure Reference: Su.Ut.18, Procedure details: Procedure for Tarpana:
The position will be kept supine as mentioned in the texts.
Eyes will be cleaned with cotton soaked in Luke warm water before the procedure.
A specially designed Tarpana goggle will be taken and used.
Ghrit will be melted by keeping in Luke warm water.
Ghrit will be poured in the amount sufficient to immerse the eyelashes.
Patients will be instructed to keep the eyes blinking at their comfort level and the blinking rates
were recorded.
The retention period will be kept the maximum time limit as constant (25 minutes) as per the
reference of Ayurvedic Pharmacopoeia of India-Part-I, Vol.-VI (1000 Matras -25min.9sec).)
| | 2 | Intervention Arm | Procedure | - | bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म | (Procedure Reference: Ch.Si.3/17,18,19,20, Procedure details: Purvakarma
Sarvang Snehan – Sarvang Snehan will be done with lukewarm Til Taila
Sarvang Swedan – Sarvang Swedan will be performed using Bashpa Sweda (Swedan Peti )
Chakshushya Basti is Prepared as per Niruha basti Sammelan vidhi process.
Pradhankarma
Patient is given left lateral position (Vama Parshwa)
Basti Netra is introduced into the Anal opening & Basti Dravya is gently pushed in a manner
that it is neither slow nor too fast.
Paschat Karma
Patient is allowed to rest in supine position for few minutes.
Snana
Sansarjan krama )
|
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1) Patient between 20-30 years of age group irrespective of gender.
2) Patient having Simple Myopia up to -6.0 D.
3) Patient having lakshanas of Pratham patalgata dosha dushti.
4) Patient fit for Basti and Tarpan |
|
| ExclusionCriteria |
| Details |
1) Patient having myopia more than -6.0D.
2) Patient having ocular diseases other than simple myopia.
3) Patient having any systemic diseases.
4) Patient having post operative myopia. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To Assess the efficacy of Chakshushya Basti in the management of Pratham Patalgat Timir with
Special Reference to Mayopia |
assessment on 1,15,30 th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) To review the Ayurvedic literature available on Timir, Yapan Basti, Chakshushya
Basti.
2) To review the Ayurvedic literature available on Tarpan.
3) To review modern literature on Myopia.
4) To compare efficacy of chakshushya basti with Yashtimadhu Ghrit Tarpan
5) To Find any adverse effect during clinical trial.
6) To Find the non Invasive alternative treatment for Myopia. |
Assessment on 1,15,30 th day |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
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 3 |
|
Date of First Enrollment (India)
|
02/05/2026 |
| 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="3"
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 - NO
|
|
Brief Summary
|
Myopia is one of the most common refractive errors affecting young adults and is comparable to Pratham Patalagata Timir described in Ayurvedic literature. Increasing prevalence of myopia leads to visual disturbances and reduced quality of life. Ayurveda describes various Chakshushya therapies for maintaining and improving eye health. Chakshushya Basti is a therapeutic procedure indicated for disorders of vision and eye strain.
The present study is a randomized controlled clinical trial designed to evaluate the efficacy of Chakshushya Basti in the management of Pratham Patalagata Timir with special reference to simple myopia. Patients aged between 20 and 30 years with simple myopia will be selected and randomly allocated into two groups. The trial group will receive Chakshushya Basti therapy according to classical Ayurvedic procedures.
The effect of the intervention will be assessed using clinical parameters related to visual function and symptoms of myopia. The study aims to evaluate the therapeutic potential of Chakshushya Basti in improving visual function and reducing symptoms associated with myopia. |