| CTRI Number |
CTRI/2024/09/073822 [Registered on: 12/09/2024] Trial Registered Prospectively |
| Last Modified On: |
30/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative Effect Of Akshi Tarpana With Tharparkar Go Ghrita And Triphla Ghrita In The Management Of Timira (Simple Myopia) |
|
Scientific Title of Study
|
A Clinical Comparative Study To Evaluate The Efficacy Of Akshi Tarpana With Tharparkar Go Ghrita And Triphla Ghrita In The Management Of 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 |
Dr Jitendra Pal Bairwa |
| Designation |
MD Scholar |
| Affiliation |
Post Graduate Institute of Ayurved |
| Address |
PG Department Of Panchkarma Post Graduate Institute Of Ayurveda Dr Sarvepalli Radhakrishnan Rajasthan Ayurveda University Campus Kadvad Jodhpur Rajasthan India 342037
Jodhpur
RAJASTHAN
342037
India |
| Phone |
7014900293 |
| Fax |
|
| Email |
paljitendrapal92@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gyan Prakash Sharma |
| Designation |
Associate Professor & HOD |
| Affiliation |
Post Graduate Institute of Ayurved |
| Address |
PG Department Of Panchkarma Post Graduate Institute Of Ayurveda Dr Sarvepalli Radhakrishnan Rajasthan Ayurveda University Campus Kadvad Jodhpur Rajasthan India 342037
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9829798701 |
| Fax |
|
| Email |
atreyagyan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jitendra Pal Bairwa |
| Designation |
MD Scholar |
| Affiliation |
Post Graduate Institute of Ayurved |
| Address |
PG Department Of Panchkarma Post Graduate Institute Of Ayurveda Dr Sarvepalli Radhakrishnan Rajasthan Ayurveda University Campus Kadvad Jodhpur Rajasthan India 342037
Jodhpur
RAJASTHAN
342037
India |
| Phone |
7014900293 |
| Fax |
|
| Email |
paljitendrapal92@gmail.com |
|
|
Source of Monetary or Material Support
|
| Post Graduate Institute of Ayurved Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Jodhpur 342037 Rajasthan India |
|
|
Primary Sponsor
|
| Name |
Post Graduate Institute of Ayurved DSRRAU Jodhpur |
| Address |
PG Department Of Panchkarma Post Graduate Institute Of Ayurved DSRRAU Jodhpur 342037 Rajasthan 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 Jitendra Pal Bairwa |
Post Graduate Institute of Ayurved DSRRAU Jodhpur |
PG Department of Panchkarma Post Graduate Institute of Ayurved DSRRAU Jodhpur Nagaur Road Kadwad Jodhpur Rajasthan
342037
Jodhpur
RAJASTHAN |
7014900293
paljitendrapal92@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee Post Graduate Institute of Ayurved |
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 | Procedure | - | netratarpaNam, नेतà¥à¤°à¤¤à¤°à¥à¤ªà¤£à¤®à¥ | (Procedure Reference: Sushrut Uttar Tantra 18/5, Procedure details: In Group A 15 patients will be given Akshi Tarpana with Tharparkar go ghrita
In Group B 15 patients will be given Akshi Tarpana with Triphala Ghrita)
(1) Medicine Name: Triphala Ghrita, Reference: Sushrut Uttar Tantra 17/31, Route: Ocular, Dosage Form: Ghrita, Dose: 100(ml), Frequency: od, Duration: 21 Days | | 2 | Comparator Arm | Procedure | - | netratarpaNam, नेतà¥à¤°à¤¤à¤°à¥à¤ªà¤£à¤®à¥ | (Procedure Reference: Sushrut Uttar Tantra 18/5, Procedure details: In Group A 15 patients will be given Akshi Tarpana with Tharparkar go ghrita In Group B 15 patients will be given Akshi Tarpana with Triphala Ghrita))
|
|
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Patient within the age group of 15 to 40 years with normal fundus will be included in
the study
Patients having signs and symptoms of Timira (Myopia) described as per Ayurveda
and Modern science
Patients who are willing to sign consent form |
|
| ExclusionCriteria |
| Details |
Patient with age below 15 year and above 40 years
Patient having any other known ocular pathology eg cataract glaucoma corneal opacity Diabetic Retinopathy and other retinal diseases
Patient having myopic degenerative changes
Refractive error greater than 6D
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To see the effect on subjective and objective parametres of procedure |
21 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To see any other effect of drug (tri[phala go ghrita & tharparkar go ghrita) & procedures (akshi tarpan ) |
21 days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
01/10/2024 |
| 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="0"
Days="21" |
|
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
|
Number Of Patients- 30 Type Of Study- An Open label trial with double arm (15 in each group) Drug- Tharparkar Go Ghrita and Triphala Ghrita Duration Of Procedure- 5-7 minute Duration Of Trial - 21 days Follow up - Will be done after 15 and 30 day after completion of treatment |