| CTRI Number |
CTRI/2026/02/104818 [Registered on: 26/02/2026] Trial Registered Prospectively |
| Last Modified On: |
25/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda Other (Specify) [comparative randomized controlled trial] |
| Study Design |
Other |
|
Public Title of Study
|
A Study on the Effect of Eye Exercises With and Without Viddhakarma in Nearsightedness (Myopia) |
|
Scientific Title of Study
|
A comparative clinical study to evaluate efficacy of eye exercise and eye exercise with viddhakarma in the management of timira with special reference to 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 Kush Sharma |
| Designation |
pg scholar |
| Affiliation |
parul institute of ayurved and research |
| Address |
department of shalakya tantra, parul institute of ayurved and research po limda tal waghodia 391760 dist vadodara gujarat india
Vadodara GUJARAT 391760 India |
| Phone |
7792008908 |
| Fax |
|
| Email |
kushdadhich18@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Jasna Chandran |
| Designation |
Associate professor |
| Affiliation |
parul institute of ayurved and research |
| Address |
department of shalakya tantra, parul institute of ayurved and research po limda tal waghodia 391760 dist vadodara gujarat india
Vadodara GUJARAT 391760 India |
| Phone |
7348976209 |
| Fax |
|
| Email |
jasnachandran9025@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Jasna Chandran |
| Designation |
Associate professor |
| Affiliation |
parul institute of ayurved and research |
| Address |
department of shalakya tantra, parul institute of ayurved and research po limda tal waghodia 391760 dist vadodara gujarat india
Vadodara GUJARAT 391760 India |
| Phone |
7348976209 |
| Fax |
|
| Email |
jasnachandran9025@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Kush Sharma |
| Address |
Department of shalakya tantra parul institute of ayurved and research parul university po limda tal waghodia 391760 dist vadodara gujrat |
| Type of Sponsor |
Other [SELF] |
|
|
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 Kush Sharma |
KHEMDAS HOSPITAL |
OPD NO.4, EYE OPD, department of shalakya tantra, Ground floor, parul institute of ayurved and research po limda tal waghodia 391760 dist vadodara gujarat india Vadodara GUJARAT |
7792008908
kushdadhich18@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PIAR-IECHR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H00-H59||Diseases of the eye and adnexa. Ayurveda Condition: TIMIRAH, (2) ICD-10 Condition:H521||Myopia. Ayurveda Condition: TIMIR, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Eye exercises | Eye wash, palming, blinking, sideways viewing, front and sideways viewing, up and down viewing, rotational viewing , nose tip gazing, near and distant viewing | | 2 | Intervention Arm | Procedure | - | vyadhana-visrAvaNa-karma, व्यधन-विस्रावण-कर्म | (Procedure Reference: Sushrutha samhitha sharirasthana chap 8, Procedure details: Pricking will be done with needle no 26 1/2 with depth about 1 to 2mm .Approximately 1 prick on lalata & apanga sandhi)
|
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
participants with difficulty in distant vision
participant in the age group 18-30 yrs irrespective of gender
participants having visual acuity up to 6/24 b/e |
|
| ExclusionCriteria |
| Details |
any systemic disease and medication that interferes with the intervention of current study
participant suffering from inflammatory and disease of eyeball and its appendages
participant who has a history of any disease at the site of puncture
pregnant women
participant with other types of myopia congenital myopia progressive myopia or acquired myopia
participant with congenital cataract and corneal opacity |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the improvement in distance visual acuity (measured by Snellen’s chart and autorefraction) before and after treatment in both groups. |
on baseline, 15th day, 30th day and 45th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the therapeutic effectiveness between eye exercises alone & eye exercises with Viddhakarma in order to determine which intervention provides better improvement in visual acuity & symptom relief. |
On 15th day, 30th day & 45th day |
|
|
Target Sample Size
|
Total Sample Size="80" Sample Size from India="80"
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 |
|
Date of First Enrollment (India)
|
01/06/2026 |
| 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="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [kushdadhich18@gmail.com].
- For how long will this data be available start date provided 01-07-2027 and end date provided 10-07-2028?
Response (Others) - One year post publication of research paper
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
this comparative clinical study evaluated the effectiveness of eye exercise alone and eye exercise combined with viddhakarma in the management of timira simple myopia the results demonstrated improvement in visual acuity and reduction in refractive error and associated symptoms in both groups with comparatively better and sustained outcomes in the combined therapy group |