| CTRI Number |
CTRI/2021/08/035436 [Registered on: 05/08/2021] Trial Registered Prospectively |
| Last Modified On: |
16/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Clinical study on use of Mahatriphaladi Ghrut in Timira. |
|
Scientific Title of Study
|
Randomised Comparative Clinical Study Between The Effect of Mahatriphaladi Ghrit Netra Tarpan, Abhyantarpana and Netra Tarpan with Abhyantarpana In Pratham and Dvitiya Patalgat Timira. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Swapnil Kundlik Chavan |
| Designation |
PG Scholar |
| Affiliation |
Yashwant Ayurved College Postgraduate Training and Research Centre ] |
| Address |
Yashwant Ayurvedic collage, Shalakyatant Department, Ophthalm OPD
kodoli, kolhapur
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
09822346923 |
| Fax |
|
| Email |
drchavanswapnil@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chandrashekhar N Mule |
| Designation |
HOD, Shalakyatantra Department, |
| Affiliation |
Yashwant Ayurved College Postgraduate Training and Research Centre ] |
| Address |
Yashwant Ayurved College Postgraduate Training and Research Centre, kodoli, panhala, kolhapur.
kodoli, kolhapur
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
09822346923 |
| Fax |
|
| Email |
drcnm05@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Swapnil Kundlik Chavan |
| Designation |
PG Scholar |
| Affiliation |
Yashwant Ayurved College Postgraduate Training and Research Centre ] |
| Address |
Yashwant Ayurvedic collage, Shalakyatant Department, Ophthalm OPD
kodoli, kolhapur
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
09822346923 |
| Fax |
|
| Email |
drchavanswapnil@gmail.com |
|
|
Source of Monetary or Material Support
|
| MATERIAL SUPPORT - DAILY OPD PATIENTS OF YASHWANT AYURVED COLLEGE, KODOLI, KOLHAPUR. |
| MONETARY SUPPORT - SWAPNIL KUNDLIK CHAVAN |
|
|
Primary Sponsor
|
| Name |
Dr SWAPNIL KUNDLIK CHAVAN |
| Address |
Yashwant Ayurvedic Collage, kodoli, kolhapur |
| Type of Sponsor |
Other [individual sponsor] |
|
|
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 Swapnil K Chavan |
Yashwant Ayurved College , Kodoli , Kolhapur |
Ophthalmic OPD
Kolhapur
MAHARASHTRA |
9822346923
drchavanswapnil@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE YAC, KODOLI, KOLHAPUR |
Not Applicable |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
age 10yrs to 40yrs |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
mahatriphala ghrut |
Comparision between mahatriphala ghrut tarpan,
mahatriphala ghrut abhyantarpan,
mahatriphala ghrut tarpan and abhyantarpan, |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients having signs and symptoms of first and second patalgat Timira will be selected. i.e Patients having Refractive error and Presbyopia will be included
2) Patients from age group 10yrs to 40yrs will be selected.
3) Patients up to 6D power will be selected.
4) Irrespective of gender, religion and socio economic status. |
|
| ExclusionCriteria |
| Details |
1) Patients having third and Fourth patalgat Timira will be excluded. i.e Kacha, Choroid, Vitreous and Retinal Disease will be excluded.
2) Patient having congenital anomalies of eyes.
3) Patient having any other known ocular pathology other than myopia eg. Corneal ulcer, bacterial conjunctivitis, etc.
4) K/H/O high myopia with degenerative and retinal changes.
5) K/C/O any systemic disorder.
6) P/H/O Refractive surgery. |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the effect of Mahatriphaladi Ghrit Netra tarpan, Abhyantarpan and both in Pratham and Dvitiya patalgat Timira. |
One and Half years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To study Timira roga in detail according to Ayurveda.
2. To Compare Timir as per modern Ophthalmology.
3. To study if any adverse effect of Mahatriphaladi Ghrit Abhyantarpan in Timira.
4. To study if any adverse effect of Mahatriphaladi Ghrit Tarpan in Timira. |
One and Half years |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "90"
Final Enrollment numbers achieved (India)="90" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/09/2021 |
| Date of Study Completion (India) |
25/07/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
25/07/2022 |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Timira is one of the Drushtigat roga. Among four abhyantar netra patal it occurs in pratham and dvitiya patal. It closely resembles with Myopia a type of refractive error in which rays of light are focused in front of retina causing blur distance vision. My Study is Randomised Comparative Clinical Study Between The Effect of Mahatriphaladi Ghrit Netra Tarpan, Abhyantarpana and Netra Tarpan with Abhyantarpana In Pratham and Dvitiya Patalgat Timira. Results will be accessed accordingly. |