| CTRI Number |
CTRI/2025/09/094193 [Registered on: 03/09/2025] Trial Registered Prospectively |
| Last Modified On: |
03/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Role of Chandanadya Varti & Timirhar Lauha in Digital Eye Strain (Netra Upghat) |
|
Scientific Title of Study
|
Role of Chandanadya Varti & Timirhar Lauha in Digital Eye Strain (Netra Upghat) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Deepika Arya |
| Designation |
PG Scholar (Shalakya Tantra) |
| Affiliation |
Rishikul Campus, Haridwar, Uttarakhand Ayurved University |
| Address |
PG Department of Shalakya Tantra, Rishikul Campus, Haridwar, Uttarakhand Ayurved University
Hardwar
UTTARANCHAL
249401
India |
| Phone |
7060336027 |
| Fax |
|
| Email |
deepika060409@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gunjan Sharma |
| Designation |
HOD & Professor, PG Department of Shalakya Tantra |
| Affiliation |
Rishikul Campus,Haridwar, Uttarakhand Ayurved University |
| Address |
PG Department of Shalakya Tantra, Rishikul Campus, Haridwar, Uttarakhand Ayurved University
Hardwar
UTTARANCHAL
249401
India |
| Phone |
9258030654 |
| Fax |
|
| Email |
gunjan06sharma@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gunjan Sharma |
| Designation |
HOD & Professor, PG Department of Shalakya Tantra |
| Affiliation |
Rishikul Campus,Haridwar, Uttarakhand Ayurved University |
| Address |
PG Department of Shalakya Tantra, Rishikul Campus, Haridwar, Uttarakhand Ayurved University
Hardwar
UTTARANCHAL
249401
India |
| Phone |
9258030654 |
| Fax |
|
| Email |
gunjan06sharma@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rishikul Campus, Haridwar,249401, Uttarakhand Ayurved University, Harrawala, Dehradun, Uttarakhand, India |
|
|
Primary Sponsor
|
| Name |
Uttarakhand Ayurved University, Harrawala, Dehradun |
| Address |
Uttarakhand Ayurved University, Harrawala, Dehradun, 248001, Uttarakhand, India |
| 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 Deepika Arya |
Rishikul Ayurvedic Hospital, Haridwar |
PG Department of Shalakya Tantra, Rishikul Campus, Haridwar, Uttarakhand Ayurved University
Hardwar
UTTARANCHAL |
7060336027
deepika060409@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Uttarakhand Ayurved University, Rishikul Campus, Haridwar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H525||Disorders of accommodation. Ayurveda Condition: NETRAROGAH/AKSHIROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Chandanadya Varti, Reference: Chakradatta, Route: Ocular, Dosage Form: Bindu/ Drops (Karna/ Nasa/ Netra), Dose: 02(drops), Frequency: qid, Bhaishajya Kal: Muhurmuhu, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: -(2) Medicine Name: Timirhar Lauha, Reference: Rasendra Sar Sangrah Netra Chikitsa, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 200(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Lukewarm Water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients between 18 to 60 years of age.
Digital device users complaining of symptoms like eye strain, blurred vision, headache, redness, burning sensation, irritated dry eye, slow refocussing and muscle fatigue.
Patients having minimum three symptoms of Digital Eye Strain.
Patients exposed to Digital device screens for at least 1 year.
Patients using digital devices for minimum 3-4hr/day continuously.
Best corrected distant visual acuity 6/6.
|
|
| ExclusionCriteria |
| Details |
Patients of age below 18 years or above 60 years.
Patients not willing to register.
Pre-existence of any systemic or metabolic disorders.
Case of chronic or acute infections of eye.
Patients having amblyopia, Squint, any retinal or ocular pathologies.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Relief in sign and symptoms of Digital Eye Strain (Netra Upghat in patient |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study effect of Chandanadya Varti & Timirhar Lauha in improvement of Digital Eye Strain (Netra Upghat) |
15 days |
|
|
Target Sample Size
|
Total Sample Size="35"
Sample Size from India="35"
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)
|
15/09/2025 |
| 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 - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- 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 (Others) - Thesis, Research article
- For how long will this data be available start date provided 02-01-1970 and end date provided 02-01-1970?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Role of Chandanadya Varti & Timirhar Lauha in Digital Eye Strain (Netra Upghat) is a single arm open label clinical study. This study will be conducted on 35 randomly selected patients from OPD/ IPD of Shalakya Tantra, Rishikul Ayurvedic Hospital, Haridwar, Uttarakhand Ayurved University. Single group of 35 patients will be administered Chandanadya Varti for topical administration and Timirhar Lauha for oral administration for 30 days. Single followup will be conducted after 15 days of completion of clinical trial. |