| CTRI Number |
CTRI/2025/09/094564 [Registered on: 11/09/2025] Trial Registered Prospectively |
| Last Modified On: |
08/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
ROLE OF PHALATRIKADI GHRITA TARPANA AND CHITRAKADI
KWATHA IN TIMIRA
(SIMPLE MYOPIA) |
|
Scientific Title of Study
|
A COMPARATIVE CLINICAL EVALUATION OF PHALATRIKADI GHRITA TARPANA AND CHITRAKADI
KWATHA ORALLY IN PRATHAMA PATALGATA TIMIRA
(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 |
GAURAV URKUDE |
| Designation |
PG SCHOLAR (SHALAKYA TANTRA) |
| Affiliation |
RISHIKUL AYURVEDIC COLLEGE, HARIDAWR |
| Address |
O.P.D. No 5, P.G. Department Of Shalakya Tantra, Rishikul Campus , Haridwar, Uttarakhand Ayurved University ( Dehardun)
O.P.D. No 5, P.G. Department Of Shalakya Tantra, Rishikul Campus, Haridwar, Uttarakhand Ayurved University ( Dehardun),
Hardwar
UTTARANCHAL
249401
India |
| Phone |
08793207634 |
| Fax |
|
| Email |
gurkude037@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrGunjan Sharma |
| Designation |
H.O.D & PROFESSOR (SHALAKYA TANTRA) |
| Affiliation |
RISHIKUL AYURVEDIC COLLEGE, HARIDAWR |
| Address |
O.P.D. No 5, P.G. Department Of Shalakya Tantra, Rishikul Campus , Haridwar, Uttarakhand Ayurved University ( Dehardun)
O.P.D. No 5, P.G. Department Of Shalakya Tantra, Rishikul Campus , Haridwar, Uttarakhand Ayurved University ( Dehardun)
Hardwar
UTTARANCHAL
249401
India |
| Phone |
09258030654 |
| Fax |
|
| Email |
gunjan06sharma@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
GAURAV URKUDE |
| Designation |
PG SCHOLAR (SHALAKYA TANTRA) |
| Affiliation |
RISHIKUL AYURVEDIC COLLEGE, HARIDAWR |
| Address |
O.P.D. No 5, P.G. Department Of Shalakya Tantra, Rishikul Campus , Haridwar, Uttarakhand Ayurved University ( Dehardun)
O.P.D. No 5, P.G. Department Of Shalakya Tantra, Rishikul Campus , Haridwar, Uttarakhand Ayurved University ( Dehardun)
Hardwar
UTTARANCHAL
249401
India |
| Phone |
08793207634 |
| Fax |
|
| Email |
gurkude037@gmail.com |
|
|
Source of Monetary or Material Support
|
| RISHIKUL AYURVEDIC COLLEGE RISHIKUL CAMPUS
UAU HARIDWAR 249401 |
|
|
Primary Sponsor
|
| Name |
UTTARAKHAND AYURVED UNIVERSITY DEHRADUN |
| Address |
UTTARAKHAND AYURVED UNIVERSITY STATION ROAD HARRAWALA DEHRADUN
248001 UTTARAKHAND INDIA |
| Type of Sponsor |
Government 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 Gaurav Urkude |
Rishikul Ayurvedic Hospital, Haridwar |
O.P.D. No 5, P.G. Department Of Shalakya Tantra, Rishikul Campus , Haridwar, Uttarakhand Ayurved University (Dehardun)
Hardwar
UTTARANCHAL |
08793207634
gurkude037@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Uttarakhand Ayurved University, Rishikul Campus, Haridwar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
MYOPIA |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | netratarpaNam, नेत्रतर्पणम् | (Procedure Reference: Sushruta Samhita Uttaratantra 18, Procedure details: Puravakarma :- Snehana, Swedana
Pradhana Karma :- Tarpana
Paschat Karma :- Dhumapana, Gandhusha)
(1) Medicine Name: Phalatrikadi Ghrita, Reference: Chakra-datta Netra-Rog Chikitsa, Route: Ocular, Dosage Form: Ghrita, Dose: 30(ml), Frequency: od, Duration: 3 Weeks | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Chitrakadi Kwatha , Reference: Yog-Ratnakar, Route: Oral, Dosage Form: Khanda /Granules, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient Having Sign and Symptoms of Prathama Patalgata Timira (Simple Myopia)
2. Patient aged between 12 to 35 years.
3. Patient having refractive error up to -6D |
|
| ExclusionCriteria |
| Details |
1. Patient having Myopia more than -6D
2. Congenital, Pathological, Functional Myopia, High Myopia
3. Patient having other ocular disease (i.e. corneal ulcer, ocular tumor, Squint etc.)
4. Patient having any systemic disease (i.e. HTN, DM etc.)
5. Patient having post operative Myopia
6. Patient having refractive error other than Myopia (i.e. Hypermetropia, Astigmatism, Presbyopia)
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
A Comparative Clinical Evaluation of Phalatrikadi Ghrita Tarpana and Chitrakadi Kwatha Orally in Prathama Patalgata Timira (Simple Myopia)
Subjectively all Sign and Symptoms of are given with Grading depending upon their severity |
30 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
A Comparative Clinical Evaluation of Phalatrikadi Ghrita Tarpana and Chitrakadi Kwatha Orally in Prathama Patalgata Timira (Simple Myopia)
Subjectively all Sign and Symptoms of are given with Grading depending upon their severity |
30 Days |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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)
|
20/09/2025 |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) - Thesis, Research Artical
- For how long will this data be available start date provided 15-10-2026 and end date provided 15-10-2027?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This is an open randomized comparative clinical study to evaluation of Phalatrikadi ghrita Tarpana and Chitrakadi Kwatha Orally in Prathama Patalgata Timira (Simple Myopia). This study will be conducted on 36 Randomly Selected Patient from OPD/IPD of Shalakya Tantra Department of Rishikul Ayurvedic College and Hospital, Rishikul Campus, Haridwar, Uttarakhand Ayurved University. Patient will be divided into 2 Group. In Group A -18 Patient will be given Tarpana with Phalatrikadi Ghrita and In Group B - 18 Patient will be given Tarpana with Phalatrikadi Ghrita and Chitrakadi Kwatha Orally for 30 days. Follow up study will be conducetd after 30 Days of treatment. The Assesment will be done on the basis of Subjective and Objective Parameters |