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CTRI Number  CTRI/2024/10/074965 [Registered on: 09/10/2024] Trial Registered Prospectively
Last Modified On: 08/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing Ancient Ayurvedic Remedies And Modern Ergonomics For Computer Vision Syndrome  
Scientific Title of Study   Clinical evaluation of Aschyotana Vidalaka and Computer Ergonomics in Computer Vision Syndrome A comparative study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Kiran Negi 
Designation  P.G. Scholar 
Affiliation  Uttarakhand Ayurved University Gurukul Campus Haridwar 
Address  OPD no 8 Department of Shalakya Tantra Gurukul Campus Uttarakhand Ayurved University Haridwar

Hardwar
UTTARANCHAL
249404
India 
Phone  7252998127  
Fax    
Email  kirannegi6991@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Aditi 
Designation  Assistant Professor 
Affiliation  Uttarakhand Ayurved University Gurukul Campus Haridwar 
Address  OPD no 8 Department of Shalakya Tantra Gurukul Campus Uttarakhand Ayurved University Haridwar

Hardwar
UTTARANCHAL
249404
India 
Phone  9719353123  
Fax    
Email  docaditi24@gmail.com  
 
Details of Contact Person
Public Query  
Name  Kiran Negi 
Designation  P.G. Scholar 
Affiliation  Uttarakhand Ayurved University Gurukul Campus Haridwar 
Address  OPD no 8 Department of Shalakya Tantra Gurukul Campus Uttarakhand Ayurved University Haridwar

Hardwar
UTTARANCHAL
249404
India 
Phone  7252998127  
Fax    
Email  kirannegi6991@gmail.com  
 
Source of Monetary or Material Support  
Uttarakhand Ayurved University Gurukul Campus Haridwar 249401 Uttarakhand India 
 
Primary Sponsor  
Name  Kiran Negi 
Address  OPD no. 8 department of Shalakya tantra Uttarakhand Ayurved University Gurukul Campus Haridwar 249401 Uttarakhand India 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Kiran Negi  Gurukul Campus Haridwar  OPD no. 8 Department of Shalakya Tantra Uttarakhand Ayurved University Gurukul Campus Haridwar
Hardwar
UTTARANCHAL 		 7252998127

kirannegi6991@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Uttarakhand Ayurved University  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:H578||Other specified disorders of eye and adnexa. Ayurveda Condition: NETRAROGAH/AKSHIROGAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-AScyotanam, आश्च्योतनम् (Procedure Reference: Su. Ut. 18/44, Procedure details: Instillation of the drug in the form of drops into the open eyes. )
(1) Medicine Name: Drakshaaadi ksheera aschyotana , Reference: chakradutta netrarog chikitsa 59/21, Route: Topical, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 2(drops), Frequency: qid, Duration: 27 Days
2Comparator ArmProcedure-biDAlaka:, बिडालक: (Procedure Reference: Sharangdhar samhita ut. 13/30, Procedure details: A semisolid paste of drugs is applied around the eyes (i.e., over the closed eyelids), leaving the eyelashes)
(1) Medicine Name: Haritaki Vidalaka , Reference: chakardutta netrarog chikitsa 59/10, Route: Topical, Dosage Form: Kalka/ Paste, Dose: 1(NA), Frequency: od, Duration: 27 Days
3Intervention ArmLifestyle--Dinacarya: , Ritucarya: , Acara Rasayana:, Other:Computer Ergonomics: use proper lighting, adjust the computer display settings, blink and rest, eye exercises, take frequent breaks, and modify the workstation , Pathya/Apathya:, Pathya:, Apathya:
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  All patients using computers for at least 3 hours per day & diagnosed with CVS as per CVS questionnaire (CVS-Q) as described in Journal of Clinical Epidemiology 68(6), 662-673, 2015.
Best corrected visual acuity: 6/6. 
 
ExclusionCriteria 
Details  Patient not willing for registration.
Patent suffering from systemic/metabolic disorders like polyarthritis, RA, HTN, diabetes, cervical spondylosis, autoimmune disorders, etc.
Cases complicated with acute/chronic infections of lid, conjunctiva, cornea, or sclera.
Patients with OSD (ocular surface disorders) due to other causes, age-related accommodative insufficiency , squint. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
The improvement will be assessed on the basis of:
CVS-Q questionnaire comprising of 16 symptoms.
 		 Assessment will be done on 1st, 8th, 18th & 28th day 
 
Secondary Outcome  
Outcome  TimePoints 
The improvement will be assessed on the basis of:
Schirmer test,
TBUT,
Amplitude of Accommodation,
Accommodation facility test,
Blinking rate. 		 Assessment will be done on 1st, 8th, 18th & 28th day 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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   N/A 
Date of First Enrollment (India)   20/10/2024 
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="1" 
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 - NO
Brief Summary   Computer vision syndrome(CVS) also called as Digital Eye Strain is the new nomenclature to the visual, ocular and systemic symptoms arising due to the long time and improper working on the computer and is emerging as a pandemic in the 21st century.
In this study there will be three groups:
Group A will follow computer ergonomics for 27 days
Group B will be given drakshaadi ksheera aschyotana in dose 2drops every hourly and haritaki vidalaka in 3 sittings of 7 days each for 27 days
Group C will be given drakshaadi ksheera aschyotana in dose 2drops every hourly and haritaki vidalaka in 3 sittings of 7 days each for 27 days along with  computer ergonomics throughout.
 
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