| CTRI Number |
CTRI/2021/07/034912 [Registered on: 15/07/2021] Trial Registered Prospectively |
| Last Modified On: |
06/05/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical study to see the effect of Ayurvedic preparations on
Timira |
|
Scientific Title of Study
|
Randomized open label clinical trial on the efficacy of
saptamrita ghrita tarpana, eye exercises and shatavaryadi
churna in vataja timira w.s.r. to astigmatism. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kavita Rathore |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Ayurveda jaipur |
| Address |
PG Department of Shalakya Tantra National Institute of Ayurveda jaipur 302002
Jaipur
RAJASTHAN
302002
India |
| Phone |
7089036457 |
| Fax |
|
| Email |
kavitarathore2138@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Shamsa Fiaz |
| Designation |
Head of Department HOD |
| Affiliation |
National Institute of Ayurveda jaipur |
| Address |
PG Department of Shalakya Tantra National Institute of Ayurveda jaipur 302002
Jaipur
RAJASTHAN
302002
India |
| Phone |
8764009846 |
| Fax |
|
| Email |
shamsa_fiaz@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kavita Rathore |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Ayurveda jaipur |
| Address |
PG Department of Shalakya Tantra National Institute of Ayurveda jaipur 302002
Jaipur
RAJASTHAN
302002
India |
| Phone |
7089036457 |
| Fax |
|
| Email |
kavitarathore2138@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Ayurveda Jaipur |
|
|
Primary Sponsor
|
| Name |
National Institute of Ayurveda |
| Address |
Madhav Vilas Palace Amer Road Jaipur 302002 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Kavita Rathore |
National Institute of Ayurveda Shalakya tantra department opd no 14 |
Madhav Vilas Palace, Amer Road, Jaipur, 302002
Jaipur
RAJASTHAN |
7089036457
kavitarathore2138@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H522||Astigmatism. Ayurveda Condition: TIMIRAH, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A |
15 patients will be treated with oral
administration of Shatavaryadi churna 5 g b/d along with
Saptamrita Ghrita Tarpana |
| Comparator Agent |
Group B |
15 patients will be treated with oral
administration of Shatavaryadi churna 5 g b/d along with
Eye exercises for 30 days |
|
|
Inclusion Criteria
|
| Age From |
8.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Patient of astigmatism with cylindrical dioptric value between
0.50 to 8.00 D
Patient diagnosed with Astigmatism between the age group of 8-
40 years |
|
| ExclusionCriteria |
| Details |
Patients having any lenticular or corneal opacity and other
known ocular pathologies like Vitreous and Retinal diseases,
Glaucoma, ARMD etc. will be excluded from the study
2. Patient taking Snehapana therapies from other routes
3. Patient taking treatment for any other systemic disease |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in visual acuity |
5 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Reduction in Asthenopia, headache and tearing
Changes in kertometry( K1 K2)
|
5 weeks |
|
|
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
02/08/2021 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
In modern science the treatment options for astigmatism include
spectacles, contact lens, and Lasik surgery which are very
expensive.
Refractive errors other than Astigmatism can be corrected with
glasses but in Astigmatism there is always some amount of
discomfort even after best correction.
Hence in order to provide efficient and better cure by cost effective
method through Ayurveda, this study is planned which
incorporates Kriya Kalpa procedures, oral drug and eye exercises
to tackle it efficiently.
Vataja Timira can be correlated to astigmatism as the patient
perceives the object as distorted in astigmatism. The refraction
differs in different meridian due to altered curvature in refractive
media which resembles Vataja afflication.
Snehana is the best treatment for Vataja disorders hence Tarpana
is selected in present disease.
In present study Saptamritam Ghrita is adopted as it has Snehana
and Ropana properties which may help in correcting the curvatural
defect in astigmatism and thereby improving the vision. Eye
exercises helps in improving the muscle strength of recti and oblique muscles of eye by helping proper focusing and alignment
and hence prove to be a useful tool in correcting the focusing
defect. Shatavaryadi Churna has Timira Roga Nashak properties,
hence is used internally to improve the nutritional aspect of eye.
AIMS AND OBJECTIVE
Aim
To evaluate the efficacy of Saptamrita Ghrita Tarpana and Eye
exercises in management of Vataja Timira w.s.r. to Astigmatism.
Objectives
1. To evaluate the effect of Eye exercises and Shatavaryadi
Churna in Vataja Timira w.s.r. to Astigmatism.
2. To evaluate the effect of Saptamritam Ghrita Tarpana and
Shatavaryadi Churna in Vataja Timira w.s.r. to
Astigmatism.
HYPOTHESIS
Null Hypothesis-H0 –
There is no difference between the effect of Saptamrita Ghrita
Tarpana and Eye exercise in Vataja Timira [Astigmatism] |