| CTRI Number |
CTRI/2026/02/102793 [Registered on: 02/02/2026] Trial Registered Prospectively |
| Last Modified On: |
30/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study To Evaluate The Efficacy Of Tiktaka Gritha Tarpana And Eye Exercise In The Management Of Astigmatism Timira |
|
Scientific Title of Study
|
An Open Label Double Arm Controlled Clinical Study To Evaluate The Efficacy Of Tiktaka Gritha Tarpana And Eye Exercise In The Management Of Astigmatism Timira |
| 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 Divya T N |
| Designation |
Pg Scholar |
| Affiliation |
SDM Institute of Ayurveda Bangalore |
| Address |
SDM Institute Of Ayurveda And Hospital , Bangalore Anchepalya , Kumbalgodu Post 560074
Bangalore KARNATAKA 560096 India |
| Phone |
9113014759 |
| Fax |
|
| Email |
divyatn00437@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Divya Stuvert |
| Designation |
Associate Professor |
| Affiliation |
SDM Institute of Ayurveda Bangalore |
| Address |
Shri Dharmasthala Manjunatheshwara Institute Of Ayurveda And Hospital Bangalore Anchepalya Kumbalgodu Post 560074
Bangalore KARNATAKA 560074 India |
| Phone |
9481028050 |
| Fax |
|
| Email |
stuvertdivya@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Divya Stuvert |
| Designation |
Associate Professor |
| Affiliation |
SDM Institute of Ayurveda Bangalore |
| Address |
Shri Dharmasthala Manjunatheshwara Institute Of Ayurveda And Hospital Bangalore Anchepalya Kumbalgodu Post 560074
Bangalore KARNATAKA 560074 India |
| Phone |
9481028050 |
| Fax |
|
| Email |
stuvertdivya@gmail.com |
|
|
Source of Monetary or Material Support
|
| SDM Institute of Ayurveda And Hospital Bangalore Anchepalya Kumbalgodu 560074 |
|
|
Primary Sponsor
|
| Name |
SDM Institute Of Ayurveda And Hospital |
| Address |
Shri Dharmasthala Manjunatheshwara Institute Of Ayurveda And Hospital Bangalore Anchepalya Kumbalgodu 560074 Shalakya Tantra Department |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Divya T N |
SDM Institute Of Ayurveda And Hospital |
OPD No 5 6 10 11 Department Of Shalakya Tantra Shri Dharmasthala Manjunatheshwara Institute Of Ayurveda And Hospital Bangalore Anchepalya Kumbalgodu Post 560074 Bangalore KARNATAKA |
9113014759
divyatn00437@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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H522||Astigmatism. Ayurveda Condition: TIMIRAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | netratarpaNam, नेत्रतर्पणम् Pradhan Karma | (Procedure Reference: Astanga Hridaya, Procedure details:
Pradhana karma
A circular wall will be constructed around the eye with dough of Masha flour & was made leak proof
Then lukewarm Gritha will be poured over closed eyes slowly, from the height of 4inches, till
the eye lashes were completely immersed in it.
The patient will be advised to open his eyes & blink gently , the
temperature of the Gritha was maintained throughout the procedure.
The procedure will be carried out for 800 mathra kalas 8-10 min
) (1) Medicine Name: Tiktaka Gritha, Reference: Astanga Hridaya, Route: Ocular, Dosage Form: Ghrita, Dose: 60(ml), Frequency: od, Duration: 9 Days | | 2 | Comparator Arm | Procedure | - | netratarpaNam, नेत्रतर्पणम् | (Procedure Reference: Astanga Hridaya, Procedure details:
Pradhana karma
A circular wall will be constructed around the eye with dough of Masha flour & was made leak proof
Then lukewarm Gritha will be poured over closed eyes slowly, from the height of 4’’, till
the eye lashes were completely immersed in it.
The patient will be advised to open his eyes and blink gently , the
temperature of the Gritha was maintained throughout the procedure.
The procedure will be carried out for 800 mathra kalas 8-10 min
) (1) Medicine Name: Mahatriphala Gritha, Reference: Chakradatta, Route: Ocular, Dosage Form: Ghrita, Dose: 60(ml), Frequency: od, Duration: 9 Days |
|
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Patient Presenting With Clinical Symptoms Of Simple Myopic Astigmatism
Patient Between 10 to 30 Years Of Age Irrespective Of Gender Are Selected
Refractive Error Ranging From minus 0.25D to minus 3.0D cylindrical
Visual Acuity Distant 0.1 to 0.7 Log MAR |
|
| ExclusionCriteria |
| Details |
Simple And Compound Hypermetropic Astigmatism Irregular Astigmatism Mixed Astigmatism
Congenital And Pathological Astigmatism.
Patient With Astigmatism Suffering From Other Systemic Disorders.
Patients With Other Ocular Surface Disorders Showing Astigmatic Signs.
Corneal dystrophy. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes In Vision From The Base Score Will Be Assessed By Visual Acuity Using log MAR Distant Vision Chart |
2 Weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Changes In Dioptric Power Of Principle Meridians Will Be Assessed From The Base Line Through Keratometry.
Changes In Regularity Of Lines From The Base Line Will Be Assessed Through Placido Disc.
Changes In The Clarity Of Lines Across Specific Meridians, Reduction In double Vision From The Base Line Will Be Assessed Through Astigmatic Fan Test.
Changes In The Cylindrical Power And Axis From The Base Line Will Be Assessed Through Auto Refractometry.
To Analyze The Decrease In Scores Of QIRC Questionnaire From The Base Score.
To Analyze The Decrease In Grading Scores Of Asthenopic Symptoms From The Base Score. |
2 Weeks |
|
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
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)
|
10/02/2026 |
| 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="1" Months="6" 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
|
Ayurveda emphasizes the supreme importance of vision, stating Sarvendriyanam nayanam pradhanam, highlighting the eye as the most vital sensory organ. Timira, described under Drishtigata Rogas, is a progressive disorder that can lead to visual impairment and blindness if untreated. In contemporary ophthalmology, Timira encompasses refractive errors, including astigmatism, which is characterized by irregular curvature of the cornea leading to blurred vision, eye strain, headache, and watering of eyes. Astigmatism accounts for a significant proportion of refractive errors worldwide, with rising prevalence attributed to increased screen time, sedentary lifestyle, and reduced outdoor activities. Conventional management options such as spectacles, contact lenses, and refractive surgeries provide symptomatic correction but do not prevent progression and may have cosmetic, economic, or procedural limitations. Ayurveda offers holistic therapeutic approaches, among which Netra Tarpana ,a Bahya Snehana procedure is indicated in Timira, particularly in Vata-predominant Tridoshaja conditions. Ghrita, described as Chakshushya, Rasayana, and Ojovardhaka, nourishes ocular tissues and pacifies Vata and Pitta doshas. The present study is an open-label, double-arm controlled clinical trial designed to evaluate and compare the efficacy of Tiktaka Ghrita Tarpana with eye exercises versus Mahatriphala Ghrita Tarpana with eye exercises in the management of astigmatism . Forty patients aged 10–30 years with simple myopic astigmatism will be randomly allocated into two groups. Both groups will receive Tarpana for 9 days followed by guided eye exercises for 20 days. Assessment will be done using subjective symptoms, visual acuity , keratometry, auto-refractometry, astigmatic fan test, and QIRC questionnaire. The study aims to scientifically validate Ayurvedic interventions in improving visual acuity, reducing asthenopic symptoms, and enhancing quality of life in patients with astigmatism . |