| CTRI Number |
CTRI/2020/03/024161 [Registered on: 23/03/2020] Trial Registered Prospectively |
| Last Modified On: |
23/07/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Efficacy of Pathyadi Varti Anjana
and Eye Exercise in Timira - Simple Myopia |
|
Scientific Title of Study
|
Efficacy of Pathyadi Varti Anjana and Eye Exercise in Timira with special reference to Simple Myopia - An Open labelled Two arm Randomised clinical study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Deenadayal Devarajan |
| Designation |
PG Scholar |
| Affiliation |
All India Institute of Ayurveda, New Delhi |
| Address |
Department of Shalakya Tantra,
All India Institute of Ayurveda,Sarita Vihar, New Delhi
New Delhi
DELHI
110076
India |
| Phone |
|
| Fax |
|
| Email |
drdayal1034@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manjusha Rajagopala |
| Designation |
Professor and Head of Department |
| Affiliation |
All India Institute of Ayurveda, New Delhi |
| Address |
Department of Shalakya Tantra,
All India Institute of Ayurveda,Sarita Vihar, New Delhi
New Delhi
DELHI
110076
India |
| Phone |
|
| Fax |
|
| Email |
bhatrajma2008@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manjusha Rajagopala |
| Designation |
Professor and Head of Department |
| Affiliation |
All India Institute of Ayurveda, New Delhi |
| Address |
Department of Shalakya Tantra,
All India Institute of Ayurveda,Sarita Vihar, New Delhi
New Delhi
DELHI
110076
India |
| Phone |
|
| Fax |
|
| Email |
bhatrajma2008@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Ayurveda, New Delhi |
|
|
Primary Sponsor
|
| Name |
All India Institute of Ayurveda |
| Address |
All India Institute of Ayurveda, SaritaVihar, New Delhi-110076 |
| 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 Deenadayal Devarajan |
All India Institute of Ayurveda |
EYE OPD - 103, Department of Shalakya Tantra, All India Institute of Ayurveda, Sarita Vihar, New Delhi - 110076
New Delhi
DELHI |
8848733503
drdayal1034@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H521||Myopia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Pathyadi Varti Anjana |
Pathyadi Varti : Dose - Approximately 60mg, Frequency - twice daily, Route of Administration - Local application as collyrium in both eyes, Duration - 42 days,
Study group : Timira - Simple myopia patients |
| Intervention |
Pathyadi Varti Anjana and Eye Exercise |
Pathyadi Varti :
Dose - Approximately 60mg,
Frequency - twice daily,
Route of Administration - Local application as collyrium in both eyes,
Duration - 42 days,
Eye exercise :
Frequency - twice daily,
Duration - 42 days,
Study group : Timira - Simple myopia patients |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1. Sign and Symptoms showing Prathama and Dwithiya Patalagata Timira
2. Functional Refractive errors in Myopia upto 6.0 D
3. Patients fit for Anjana
 |
|
| ExclusionCriteria |
| Details |
1. Patients not willing to participate in the study.
2. Patients having other systemic disease or metabolic disorders such as hypertension, diabetic mellitus and thyroid and any other illness.
3. Patients having any lenticular or Corneal opacity and any other known ocular pathology such as optic atrophy, diabetic retinopathy and hypertensive retinopathy.
4. History of any surgical intervention to eye. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduction in symptoms and 0.5D improvement in clinical refraction.
|
21 day, 42 day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in unaided visual acuity |
21 day, 42 day |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "24"
Final Enrollment numbers achieved (India)="24" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
15/04/2020 |
| Date of Study Completion (India) |
15/04/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Simple myopia is an important health issue in India with high incidence and progression. This condition comes under the purview of “TImira†in Ayurveda. Ocular health can be maintained and promoted by existing treatment modalities in Ayurveda. The management can be fastened if those are supplemented by some ocular strengthening therapy. Approach of Ayurveda may certainly provide good results in myopia by judiciously planning the ocular treatment along with eye exercises. This study is an attempt to evaluate the efficacy of Pathyadi Varti (Ayurveda drug) in the form of Anjana (Collyrium) alone and along with eye exercise in Timira with special reference to simple myopia. |