| CTRI Number |
CTRI/2024/10/075327 [Registered on: 15/10/2024] Trial Registered Prospectively |
| Last Modified On: |
08/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Akshi Tarpana with Go-Ghrit ( pathmeda goshala) In the Management of Timira (Simple Myopia) |
|
Scientific Title of Study
|
A Clinical Study to Evaluate the Efficacy of Akshi Tarpana with Go-Ghrit ( pathmeda goshala) 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 GYAN PRAKASH SHARMA |
| Designation |
ASSOCIATE PROFESSOR AND HEAD OF DEPARTMENT OF DEPARTMENT |
| Affiliation |
POST GRADUATE INSTITUTE OF AYURVED |
| Address |
PG DEPARTMENT OF PANCHKARMA POST GRADUATE INSTITUTE OF AYURVED DR SARVAPALLI RADHAKRISHANAN RAJASTHAN AYURVED UNIVERSITY CAMPUS KADVAD JODHPUR RAJASTHAN INDIA 342037
PG DEPARTMENT OF PANCHKARMA POST GRADUATE INSTITUTE OF AYURVED DR SARVAPALLI RADHAKRISHANAN RAJASTHAN AYURVED UNIVERSITY CAMPUS KADVAD JODHPUR RAJASTHAN INDIA 342037
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9829798701 |
| Fax |
|
| Email |
atreyagyan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR GYAN PRAKASH SHARMA |
| Designation |
ASSOCIATE PROFESSOR AND HEAD OF DEPARTMENTOF DEPARTMENT |
| Affiliation |
POST GRADUATE INSTITUTE OF AYURVED |
| Address |
PG DEPARTMENT OF PANCHAKARMA POST GRADUATE INSTITUTE OF AYURVED DR SARVAPALLI RADHAKRISHANAN RAJASTHAN AYURVED UNIVERSITY CAMPUS KADVAD JODHPUR RAJASTHAN INDIA 342037
PG DEPARTMENT OF PANCHAKARMA POST GRADUATE INSTITUTE OF AYURVED DR SARVAPALLI RADHAKRISHANAN RAJASTHAN AYURVED 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 GYAN PRAKASH SHARMA |
| Designation |
ASSOCIATE PROFESSOR AND HEAD OF DEPARTMENT OF DEPARTMENT |
| Affiliation |
POST GRADUATE INSTITUTE OF AYURVED |
| Address |
PG DEPARTMENT OF PANCHAKARMA POST GRADUATE INSTITUTE OF AYURVED DR SARVAPALLI RADHAKRISHNAN RAJASTHAN AYURVED UNIVERSITY CAMPUS KADVAD JODHPUR RAJASTHAN INDIA 342037
PG DEPARTMENT OF PANCHAKARMA POST GRADUATE INSTITUTE OF AYURVED DR SARVAPALLI RADHAKRISHNAN RAJASTHAN AYURVED UNIVERSITY CAMPUS KADVAD JODHPUR RAJASTHAN INDIA 342037
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9829798701 |
| Fax |
|
| Email |
atreyagyan@gmail.com |
|
|
Source of Monetary or Material Support
|
| POST GRADUATE INSTITUTE OF AYURVED DR SARVAPALLI RADHAKRISHNAN RAJASTHAN AYURVEDA UNIVERSITY JODHPUR RAJASTHAN 342037 |
|
|
Primary Sponsor
|
| Name |
POST GRADUATE INSTITUTE OF AYURVED DR SARVAPALLI RADHAKRISHANAN RAJASTHAN AYURVEDA UNIVERSITY |
| Address |
PG DEPARTMENT OF PANCHAKARMA POST GRADUATE INSTITUTE OF AYURVED DR SARVAPALLI RADHAKRISHANAN RAJASTHAN AYURVED UNIVERSITY CAMPUS KADVAD JODHPUR RAJASTHAN INDIA 342037 |
| 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 GYAN PRAKASH SHARMA |
POST GRADUATE INSTITUTE OF AYURVED DSRRAU JODHPUR |
PG DEPARTMENT OF PANCHAKARMA POST GRADUATE INSTITUTE OF AYURVED DR SARVAPALLI RADHAKRISHANAN RAJASTHAN AYURVED UNIVERSITY CAMPUS KADVAD JODHPUR RAJASTHAN INDIA 342037
Jodhpur
RAJASTHAN |
09829798701
atreyagyan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PGIA INSTITUTIONAL ETHICS COMMITTEE DR SARVAPALLI RADHAKRISHANAN RAJASTHAN AYURVEDA UNIVERSITY |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H539||Unspecified visual disturbance. 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: SUSRUTA UTTARTANTRA 18, Procedure details: 100 PATIENT WILL BE TREATED WITH NETRA TARPANA WITH GO GHRIT(PATHMEDA GAUSHALA))
|
|
|
|
Inclusion Criteria
|
| Age From |
8.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Patient of myopia with dioptric value between -0 .5 D to -6 D. |
|
| ExclusionCriteria |
| Details |
patient having a diopter power greater then -6.0 D
Age below 8 years and more then 40 years will excluded
subject having any systemic illness will excluded |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Any changes in Visual acuity score |
28 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| TO SEE ANY OTHER EFFECT OF DRUG AND PROCEDURE |
28 days |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
21/10/2024 |
| 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="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
|
Myopia also called as short-sightedness, is a type of refractive error in which parallel rays of light coming from infinity are focused before the retina when accommodation is at rest. while the modern alternative in the field of ophthalmology has made tremendous and remarkable progress, there is no satisfactory and globally accepted cure for simple myopia. Ayurveda may provide a ray of hope through its holistic approach and radical treatment like panchakarma which correct the basic physiology by eliminating the chief causative factors without any adverse affect. present study is a open label clinical trial, which will be conducted on 100 subjects of Timira (simple myopia). Intervention/Procedure- Akshitarapana with Go Ghrit (Pathmeda Gaushala) will be administered 7 consecutive days followed by gap 7 days. process will be continued for 28 days. Changes in objective and subjective parameters of Timira (simple myopia) will be the endpoints of the study. |