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CTRI Number  CTRI/2024/07/070899 [Registered on: 19/07/2024] Trial Registered Prospectively
Last Modified On: 16/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Evaluate the effect of Ghritkumaryadi Aschyotan (Eye drops) with Glycerine in the Management of Computer Vision Syndrome  
Scientific Title of Study   A Clinical Study to Evaluate the effect of Ghritkumaryadi Aschyotan (Eye drops) with Glycerine in the Management of Computer Vision Syndrome  
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 Sukhdev Singh 
Designation  Professor, P.G. Department of Shalakya Tantra 
Affiliation  Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital Paprola,Kangra H.P.  
Address  Department of Shalakya Tantra Room no. 210(A) Anatomy block Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital ,Paprola,Kangra H.P.

Kangra
HIMACHAL PRADESH
176115
India 
Phone  9418471230  
Fax    
Email  drsukhdev@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sukhdev Singh 
Designation  Professor, P.G. Department of Shalakya Tantra 
Affiliation  Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital Paprola,Kangra H.P.  
Address  Department of Shalakya Tantra Room no. 210(A) Anatomy block Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital ,Paprola,Kangra H.P.

Kangra
HIMACHAL PRADESH
176115
India 
Phone  9418471230  
Fax    
Email  drsukhdev@gmail.com  
 
Details of Contact Person
Public Query  
Name  Shabnam Verma  
Designation  PG Scholar , Department of Shalakya Tantra 
Affiliation  Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital Paprola,Kangra H.P.  
Address  Department of Shalakya Tantra OPD 219 Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital Paprola,Kangra H.P.

Kangra
HIMACHAL PRADESH
176115
India 
Phone  7018708630  
Fax    
Email  shabnamverma24@gmail.com  
 
Source of Monetary or Material Support  
Baijnath Pharmacy,Paprola Distt Kangra, H.P., Charak Pharmacy Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital, Paprola, Research institute in I.S.S.M Jogindernagar, H.P. 176115 ,India  
 
Primary Sponsor  
Name  Principal Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital Paprola 
Address  Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital Paprola,Distt.Kangra H.P. 176115 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
Dr Sukhdev Singh  Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital Paprola,Distt.Kangra H.P. 176115 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sukhdev Singh  R.G.G.P.G Ayurvedic college and Hospital paprola,H.P. 176115, India  OPD 219, Department of Shalakya Tantra, R.G.G.P.G.Ayurvedic college and Hospital paprola Kangra HIMACHAL PRADESH, 176115, India
Kangra
HIMACHAL PRADESH 		 9418471230

drsukhdev@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC Human RGGPG Ayurvedic College Paprola  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:H539||Unspecified visual disturbance. Ayurveda Condition: NETRAROGAH/AKSHIROGAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-AScyotanam, आश्च्योतनम् (Procedure Reference: Sushruth samhita uttar tantra 18, Procedure details: 1-2 drops of Ghritkumaryadi Aschyotan with glycerine in each eye 4-6 times per day )
2Comparator ArmProcedure-AScyotanam, आश्च्योतनम् (Procedure Reference: Sushruth samhita uttar tantra 18, Procedure details: 1-2 drops of Ghritkumaryadi Aschyotan 4-6 times per day)
3Intervention ArmDrugClassical(1) Medicine Name: Ghritkumaryadi Aschyotan , Reference: Bhavprakash nighantu , Dhanvantri nighantu, Route: Topical, Dosage Form: Bindu/ Drops (Karna/ Nasa/ Netra), Dose: 2(drops), Frequency: qid, Bhaishajya Kal: Muhurmuhu, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: -Nil
 
Inclusion Criteria  
Age From  10.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patient willing to undergo trial.
2.Patient using computer for atleast 2 hours per day presenting with the clinical features of computer vision syndrome
3.Age group above 10 years  
 
ExclusionCriteria 
Details  1. Patients not willing to undergo trial.
2. Patient suffering from computer vision syndrome associated with other ocular disease ( e.g.conjunctivitis, eyelid disorders, corneal ulcers, lagopthalmos, dacrocystitis and other infective, fungal and allergic conditions.
3. Patients suffering from systemic/ metabolic disorders like diabetes, hypertension, cardiovascular disease.
4.patients suffering from moderate to severe anaemia.
5. Age group above 60 years.
4.  
 
Method of Generating Random Sequence   Other 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Effect of Aschyotan Kriyakalp with Ghritkumaryadi Aschyotan with glycerine (Eye drops) on Computer Vision Syndrome.  15 days  
 
Secondary Outcome  
Outcome  TimePoints 
1. Evaluate the effect of Ghritkumaryadi Aschyotan in the management of computer vision syndrome.
2. To study the untoward effects of drug if any.  		 15 days  
 
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)   20/08/2024 
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="0"
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 - NO
Brief Summary   Thirty patients fulfilling the inclusion criteria will be selected and will be divided into two groups. One group will be treated with Ghritkumaryadi aschyotan(drops) with glycerine and other group will be treated with Ghritkumaryadi Aschyotan( drops) only.   Then before and after effect of the drug on computer vision syndrome will be analysed with appropriate statistical tools. 
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