| CTRI Number |
CTRI/2022/09/045659 [Registered on: 19/09/2022] Trial Registered Prospectively |
| Last Modified On: |
14/09/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
|
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Structural Anatomy Of Eye And Releted To Stages Of Timir |
|
Scientific Title of Study
|
An Anatomical Study Of Netra Sharir W.S.R. To Timir |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Garima Garg |
| Designation |
PG Scholar |
| Affiliation |
Madan Mohan Malviya Government Ayurved College Radaji Circle Amba Mata Udaipur |
| Address |
Madan Mohan Malviya Government Ayurved College Radaji Circle Amba Mata Udaipur
Madan Mohan Malviya Government Ayurved College Radaji Circle Amba Mata Udaipur
Udaipur
RAJASTHAN
321022
India |
| Phone |
7297942855 |
| Fax |
|
| Email |
garimagarg22855@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR DINESH KUMAR SHARMA |
| Designation |
ASSISTENT PROFESSER |
| Affiliation |
Madan Mohan Malviya Government Ayurved College Radaji Circle Amba Mata Udaipur |
| Address |
Madan Mohan Malviya Government Ayurved College Radaji Circle Amba Mata Udaipur
Udaipur
RAJASTHAN
313004
India |
| Phone |
9460590939 |
| Fax |
|
| Email |
drdineshanatomy@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR DINESH KUMAR SHARMA |
| Designation |
ASSISTENT PROFESSER |
| Affiliation |
Madan Mohan Malviya Government Ayurved College Radaji Circle Amba Mata Udaipur |
| Address |
Madan Mohan Malviya Government Ayurved College Radaji Circle Amba Mata Udaipur
Udaipur
RAJASTHAN
313004
India |
| Phone |
9460590939 |
| Fax |
|
| Email |
drdineshanatomy@gmail.com |
|
|
Source of Monetary or Material Support
|
| Madan Mohan Malviya Government Ayurved College Radaji Circle Amba Mata Udaipur |
|
|
Primary Sponsor
|
| Name |
Madan Mohan Malviya Government Ayurved College Udaipur |
| Address |
Radaji Circle Amba Mata Udaipur |
| 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 Garima Garg |
MMM Ayurved College Udaipur And SSB Setelite District Hospital Udaipur |
Radaji Circle Amba Mata Udaipur And In Front Of Amba Mata Police Station Udaipur
Udaipur
RAJASTHAN |
7297942855
garimagarg22855@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE MMM GOVT. AYURVED COLLEGE AMBA MATA UDAIPUR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H251||Age-related nuclear cataract, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients Of Either Sex With Age Group Between 40-60 Years
All Stages Of Senile Cataract |
|
| ExclusionCriteria |
| Details |
Congenital Cataract
Traumatic Cataract
Drug Induced Cataract
Cataract Associated With Ocular Disease And Systemic Disease Like Diabetes |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Observe And Asses Clinical Features Of Timir In Modern Prespective Of Progressive Stages Of Senile Cataract On Included OPD Cataract Patient |
8weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Corelation Of Senile Cataract With Stages Of Timir |
12weeks |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
20/09/2022 |
| 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
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Detailed Anatomy Of Netra Sharir In Modern Prespective And Ayurvedic prespective Observe And Assess Clinical Features Of Timir In Modern Prespective Of Progressive Stages Of Senile Cataract In OPD Patients |