| CTRI Number |
CTRI/2026/02/102694 [Registered on: 02/02/2026] Trial Registered Prospectively |
| Last Modified On: |
31/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Conservative Treatment] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To Study Efficacy Of Drushtiprada Varti In Short-sightedness. |
|
Scientific Title of Study
|
A Single Arm Clinical Study On Efficacy Of Drushtiprada Varti In The Management Of Timira With Special Reference To Simple 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 Harshada Rupesh Terdale |
| Designation |
PG Scholar Shalakyatantra |
| Affiliation |
Dayabhai Maoji Majithiya Ayurved Mahavidyalaya, Yavatmal. |
| Address |
Dayabhai Maoji Majithiya Ayurved Mahavidyalaya affiliated with L.K. Ayurved Rugnalaya, Department of Shalakyatantra, Ground Floor, OPD No. 16, Yavatmal.
Yavatmal
MAHARASHTRA
445001
India |
| Phone |
9175411260 |
| Fax |
|
| Email |
harshadaterdale19@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Santosh Ganesh Sontakke |
| Designation |
Associate Professor, M.S. ( Shalakyatantra) |
| Affiliation |
Dayabhai Maoji Majithiya Ayurved Mahavidyalaya, Yavatmal |
| Address |
Dayabhai Maoji Majithiya Ayurved Mahavidyalaya affiliated with L.K. Ayurved Rugnalaya, Department of Shalakyatantra, Ground Floor, OPD No. 16, Yavatmal.
Yavatmal
MAHARASHTRA
445001
India |
| Phone |
9403442294 |
| Fax |
|
| Email |
Sant.sontakke@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Harshada Rupesh Terdale |
| Designation |
PG Scholar Shalakyatantra |
| Affiliation |
Dayabhai Maoji Majithiya Ayurved Mahavidyalaya, Yavatmal |
| Address |
Dayabhai Maoji Majithiya Ayurved Mahavidyalaya affiliated with L.K. Ayurved Rugnalaya, Department of Shalakyatantra, Ground Floor, OPD No. 16, Yavatmal.
Yavatmal
MAHARASHTRA
445001
India |
| Phone |
9175411260 |
| Fax |
|
| Email |
harshadaterdale19@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dayabhai Maoji Majithiya Ayurved Mahavidyalaya affiliated with L.K. Ayurved Rugnalaya, Department of Shalakyatantra, Ground Floor, OPD No. 16, Shivaji Nagar, Arni Road, Dist- Yavatmal 445001. |
|
|
Primary Sponsor
|
| Name |
DMM Ayurved Mahavidyalaya, Yavatmal |
| Address |
Dayabhai Maoji Majithiya Ayurved Mahavidyalaya affiliated with L.K. Ayurved Rugnalaya, Department of Shalakyatantra, Ground Floor, OPD No. 16, Shivaji Nagar, Arni Road, Dist- Yavatmal 445001. |
| Type of Sponsor |
Other [Research Institution and hospital] |
|
|
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 Harshada Rupesh Terdale |
L.K. Ayurved Rugnalaya, Yavatmal. |
OPD No. 16, Ground floor, Department of Shalakyatantra, Dayabhai Maoji Majithiya Ayurved Mahavidyalaya affiliated with L.K. Ayurved Rugnalaya, Shivaji nagar, Arni Road, Yavatmal. 445001
Yavatmal
MAHARASHTRA |
09175411260
harshadaterdale19@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, D.M.M Ayurved Mahavidyalaya, Yavatmal |
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 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Drushtiprada Varti, Reference: Gadhanigraha of Vaidya Shodhala ,Uttar Tantra 3, shlok no. 260, Route: Topical, Dosage Form: Varti/ Suppository, Dose: 40(mg), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
11.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients having symptoms of Simple Myopia.
2. From -0.25 Dioptric power to -3.00 Dioptric power.
|
|
| ExclusionCriteria |
| Details |
1. Patient not willing for trial.
2. Patient having other systemic disorders.
3. Patients of pathological or degenerative Myopia, Congenital Myopia, Secondary Myopia will be excluded from study.
4. Patients having retinal or macular diseases.
5. Any refractive surgery already done before. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The parameters will be noted before and after the treatment.
1. Avyaktadarshana (Diminish of vision).
2. Shiroabhitapa (Headache).
3. Netradaha ( Burning Sensation).
4. Snellens Chart (Acuity Of vision ).
5. Slit Lamp.
6. Dioptric power of patient.
7. Direct Ophthalmoscope.
8. Retinoscope |
10th, 20th, 30th day will be the follow up days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Upto 6/60 - Grade 0 - No improvement.
2. Upto 6/24 - Grade 1- Mild improvement.
3. Upto 6/12 - Grade 2 - Moderate improvement.
4. 6/9 - 6/6 - Grade 3 - Good improvement.
|
10th, 20th, 30th day will be the follow up days. |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
30/03/2026 |
| 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 Yet Recruiting |
| 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
|
A Single Arm Clinical Study On Efficacy Of Drushtiprada Varti In The Management Of Timira With Special Reference To Simple Myopia. Location Of Study OPD section of shalakya tantra department of the attached college and hospital. A total of 50 patients diagnosed with Timira will receive treatment of Dushtiprada Varti Anjana. The duration of study will be 30 days. The total duration will be 18 months. The results will be concluded in the end. Data analysis will be done using proper statistical test. |