| CTRI Number |
CTRI/2025/10/095822 [Registered on: 09/10/2025] Trial Registered Prospectively |
| Last Modified On: |
09/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Comparison of Two Traditional Ayurvedic Eye Treatments – Using Herbal Eye Pouch (Pindi) and a Ghee-Based Eye Bath (Tarpana) – for Treating Vataja Timira (Astigmatism) |
|
Scientific Title of Study
|
Comparative clinical evaluation of Pindi and Tarpana in Vataja Timira (Astigmatism) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anita Pimoli |
| Designation |
PG Scholar |
| Affiliation |
Uttarakhand Ayurved University Gurukul Campus Haridwar 249404 Uttarakhand |
| Address |
OPD no 8 department of shalakya tantra uttarakhand ayurved university gurukul campus haridwar uttarakhand
Hardwar
UTTARANCHAL
249404
India |
| Phone |
7830120125 |
| Fax |
|
| Email |
anitapimoli97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aditi |
| Designation |
Assistant Professor |
| Affiliation |
Uttarkhand Ayurveda University, Gurukul Campus Haridwar, Uttarkhand 249404 |
| Address |
OPD no 8 department of shalakya tantra uttarakhand ayurved university gurukul campus haridwar uttarakhand
Hardwar
UTTARANCHAL
249404
India |
| Phone |
9719353123 |
| Fax |
|
| Email |
docaditi24@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anita Pimoli |
| Designation |
PG Scholar |
| Affiliation |
Uttarkhand Ayurved University Gurukul campus haridwar uttarakhand |
| Address |
OPD no 8 department of shalakya tantra uttarakhand ayurved university gurukul campus haridwar
Hardwar
UTTARANCHAL
249404
India |
| Phone |
7830120125 |
| Fax |
|
| Email |
anitapimoli97@gmail.com |
|
|
Source of Monetary or Material Support
|
| PG Department of shalakya tantra, Uttarakhand ayurveda university, Gurukul Campus Haridwar, Uttarakhand
pincode 249404
India |
|
|
Primary Sponsor
|
| Name |
Anita Pimoli |
| Address |
OPD no 8, department of Shalakya tantra, Uttarakhand Ayurved University, Gurukul campus, Haridwar, Uttarkhand
pincode- 249404
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 Anita Pimoli |
Uttarakhand Ayurved University, Gurukul Campus, Haridwar Uttarakhand |
OPD no 8, department of shalakya tantra, gurukul campus, haridwar Uttarkhand
pincode 249404
India
Hardwar
UTTARANCHAL |
7830120125
anitapimoli97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Uttarakhand Ayurved University |
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 | - | piNDI, पिण्डी | (Procedure Reference: sharangdhar samhita uttar khand 13/21, Procedure details: In this paste of medications are covered in a cloth and picked over closed eyes. It is also called as Kavalika.)
(1) Medicine Name: Dashmool , Reference: Sushruta sutra 38/72, Route: Topical, Dosage Form: Kalka/ Paste, Dose: 6(g), Frequency: od, Duration: 21 Days | | 2 | Comparator Arm | Procedure | - | netratarpaNam, नेत्रतर्पणम् | (Procedure Reference: Sushrut uttara tantra 18, Procedure details: It is a procedure in which comfortably warm medicated ghee is kept over the eyes for a certain period of time with the help of a specially formed frame ring prepared from black gram powder or similar material that help to retain medicated ghee for
certain duration.)
(1) Medicine Name: Dashmool Ghrita, Reference: Yogratnakar uttarardha netraroga, Route: Topical, Dosage Form: Ghrita, Dose: 20(ml), Frequency: od, Duration: 21 Days |
|
|
|
Inclusion Criteria
|
| Age From |
9.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Patients with sign and symptoms of Vataja Timira.
Patients willing to register.
Patients under the age group 9-40 years.
Optical correction ranging from +/-0.25D(cyl) to +/-3D(cyl).
|
|
| ExclusionCriteria |
| Details |
Patients having corneal opacity, pterygium, keratoconus and any other ocular pathology.
Presbyopia & other refractive error.
Optical correction more than +/- 3 D(cyl).
Patients with uncontrolled HTN & DM.
Irregular astigmatism. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
The improvement will be assessed on the basis -
Bhramantiva sa pashyati(defective vision)
Aavila roopa(blurring of vision)
Vyavidha roopa(distortion of objects)
Headache |
Assessment will be done on 1st, 11th, 21st and 27th day. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The improvement will be assessed on the basis of -
Visual acuity
Dioptric power
Sims k value(k2-k1). |
Assessment will be done on 1st, 11th, 21st and 27th day. |
|
|
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 |
|
Date of First Enrollment (India)
|
20/10/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
20/10/2025 |
| 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
|
This study is an open level randomized parallel arm clinical trial to determine the efficacy of Pindi and Tarpana in Vataja Timira (Astigmatism) for the age group between 9 to 40 years for 27 days. The study will be conducted at Uttarakhand Ayurveda University, Gurukul Campus, Haridwar on 40 patients. Assessment will be done on the basis of subjective and objective parameters. Study will be conducted at OPD IPD level of PG department of Shalakya Tantra. Assessment will be done on 1st, 11th, 21st and 27th day of clinical trial and result obtained will be tabulated and statistically analyzed using appropriate tests. |