| CTRI Number |
CTRI/2026/01/100453 [Registered on: 07/01/2026] Trial Registered Prospectively |
| Last Modified On: |
06/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effects of Netra-Tarpana in Myopia. |
|
Scientific Title of Study
|
A Pilot Clinical Study to Assess the Effect of Netra-Tarpana on Certain Ocular Parameters in Patients with 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 Varsha Raj |
| Designation |
PG Scholar |
| Affiliation |
Government Ayurvedic College and Hospital, Kadamkuan, Patna, Bihar, India. |
| Address |
Department of Shalakya Tantra, Government Ayurvedic College and Hospital, Kadamkuan, Patna, Bihar, India.
Patna
BIHAR
800003
India |
| Phone |
9430031115 |
| Fax |
|
| Email |
varsha.raj.10@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ruby Kumar |
| Designation |
Associate Professor |
| Affiliation |
Government Ayurvedic College and Hospital, Kadamkuan, Patna, Bihar, India. |
| Address |
Department of Shalakya Tantra, Government Ayurvedic College and Hospital, Kadamkuan, Patna, Bihar, India.
Patna
BIHAR
800003
India |
| Phone |
8210002352 |
| Fax |
|
| Email |
dr.rubybhu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Varsha Raj |
| Designation |
PG Scholar |
| Affiliation |
Government Ayurvedic College and Hospital, Kadamkuan, Patna, Bihar, India. |
| Address |
Department of Shalakya Tantra, Government Ayurvedic College and Hospital, Kadamkuan, Patna, Bihar, India.
Patna
BIHAR
800003
India |
| Phone |
9430031115 |
| Fax |
|
| Email |
varsha.raj.10@gmail.com |
|
|
Source of Monetary or Material Support
|
| Goverment ayurvedic college and hospital,Kadamkuan, Patna, Bihar- 800003, India |
|
|
Primary Sponsor
|
| Name |
Dr Varsha Raj |
| Address |
Department of Shalakya Tantra, OPD - Room No.2, Goverment Ayurvedic College and Hospital, Kadamkuan, Patna-800003, Bihar, India |
| Type of Sponsor |
Other [Self] |
|
|
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 Varsha Raj |
Goverment Ayurvedic College and Hospital, Patna |
Room No.2, Shalakya-Netra Roga OPD
Patna
BIHAR |
9430031115
varsha.raj.10@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H53-H54||Visual disturbances and blindness. Ayurveda Condition: TIMIRAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | Poorva Karma – Local Snehana (with Tila taila), Mridu Swedana, and Nasya (with Shadbindu Taila) | (Procedure Reference: Sushruta Samhita Uttartantra, Chapter 18, Verse 5-8 , Procedure details: Poorva Karma – Local Snehana (with Tila taila), Mridu Swedana, & Nasya (with Shadbindu Taila))
| | 2 | Intervention Arm | Procedure | - | Pradhan Karma - Netra Tarpana | (Procedure Reference: Sushruta Samhita Uttartantra, Chapter 18, Verse 5-10, Procedure details: Netra-tarpana with Mahatriphala Ghrita (30 ml) - 3 sittings for 7 days with an interval of 15 days.)
(1) Medicine Name: Mahatriphala Ghrita, Reference: Ashtanga Hridaya Uttartantra, Chapter 13, Verse 12-13, Route: Ocular, Dosage Form: Ghrita, Dose: 30(ml), Frequency: od, Duration: 7 Days | | 3 | Intervention Arm | Procedure | - | Paschata Karma | (Procedure Reference: Shushruta Samhita Uttartantra, Chapter 18, Verse 5-11, Procedure details: Netra- prakshalana with lukewarm water.)
|
|
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Patients who meet the following criteria will be selected for the study:
1. Patients aged 10 to 45 years.
2. Patients diagnosed with myopia with spherical equivalent refractive error between minus 0.5 to minus 6.0 diopters.
3. Patients with stable refractive status for at least six months prior to enrollment.
4. Patients without any systemic disease that may affect ocular health, such as uncontrolled diabetes or autoimmune disorders.
5. Patients who are able and willing to provide written informed consent and are likely to complete the entire course of the study as per instructions.
|
|
| ExclusionCriteria |
| Details |
Patients will be excluded from enrollment if they have:
1. High myopia with spherical equivalent refractive error greater than minus 6.0 diopters.
2. History of ocular surgery, such as refractive or cataract surgery, within the past one year.
3. Presence of ocular pathology other than myopia, such as glaucoma, retinal detachment, or macular degeneration.
4. Female patients who are pregnant, planning pregnancy during the study period, or lactating.
5. Current use or planned use of contact lenses during the study period.
6. Severe dry eye syndrome or any ocular surface disease that may affect study outcomes.
7. Use of ocular medications such as topical steroids or anti-glaucoma drugs that may interfere with the assessment of outcomes.
8. In cases of bilateral myopia, both eyes will be considered for inclusion in the study.
9. Inability to continue the proposed duration of treatment or attend follow-up visits.
10. Current participation in another clinical trial or participation in an ocular clinical trial within the past three months.
11. Development of any complications during the study period.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
a. To determine the mean change in visual acuity at the end of treatment compared with baseline.
b. To determine the mean change in the spherical equivalent of refraction at the end of treatment compared with baseline.
|
day 0, day 7, day 23, day 29, day 45, and day 52. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
a. To determine the mean change in keratometry readings at the end of treatment compared with baseline.
b. To determine the mean change in axial length at the end of treatment compared with baseline.
c. To determine the mean change in anterior chamber depth at the end of treatment compared with baseline.
d. To determine the mean change in intraocular pressure at the end of treatment compared with baseline.
|
day 0, day 7, day 23, day 29, day 45, and day 52 |
|
|
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)
|
22/01/2026 |
| 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="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
|
Purpose: To assess the effect of Netra-Tarpana (utilizing Mahatriphaladi ghrita) on certain ocular parameters, including best corrected visual acuity (BCVA), refractive error, prescription strength, keratometry readings, axial length, and intraocular pressure (IOP) in individuals with myopia.
Study Design: Clinical, prospective, open-labeled, single-group, single-blind, pilot study.
Participants: (n = 40) Patients of either gender, aged 10-45 years, diagnosed with myopia with spherical equivalent refractive error between -0.5 to -6.0 diopters, with stable refractive status for at least six months prior to enrollment. The diagnosis of myopia will be made on baseline day (day 0) using objective (retinoscopy, autorefractometer) and subjective refraction, and the spherical equivalent will be recorded for best corrected visual acuity.
Methods: All recruited participants (n = 40) will undergo Poorva Karma (local snehana with Tila Taila, Mridu Swedana, and Nasya with Shadbindu Taila), followed by Pradhana Karma - Netra-Tarpana with Mahatriphala Ghrita (30 ml) for three seven-day sittings at fifteen-day intervals - and Pashchat Karma with lukewarm-water Netra-Prakshalana. Standardized and certified formulations will be used. Baseline evaluation will include visual acuity, refraction, slit-lamp and fundus examination, IOP measurement, keratometry, and A-scan biometry. All parameters will be assessed before and after each sitting; changes in refractive status and ocular findings will be documented, and participant feedback will be recorded. follow-up will occur on day 0, 7, 23, 29, 45, 52.
Main Outcome Measures: The primary efficacy outcomes will include changes in visual acuity and spherical equivalent refractive error from baseline to the end of treatment. Secondary outcomes will assess changes in keratometry readings, axial length, anterior chamber depth, and intraocular pressure over the study period.
Results: The mean change in all assessment parameters will be analyzed using appropriate parametric or non-parametric statistical tests, as recommended by the statistician, to compare baseline and post-treatment values. A p-value of 0.05 or less will be considered statistically significant for all analyses.
|