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CTRI Number  CTRI/2025/02/081243 [Registered on: 24/02/2025] Trial Registered Prospectively
Last Modified On: 19/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A Study to compare efficacy of Go-Ghrita Aschyotana and Shadanga Guggulu in Shushkakshipaka (Computer Vision Syndrome) 
Scientific Title of Study   A Randomized Clinical Trial To Evaluate The Efficacy Of Go-Ghrita Aschyotana With And Without Shadanga Guggulu Orally In The Management Of Shushkakshipaka W.S.R. To Computer Vision Syndrome(CVS) 
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 Rishabh Sikarwal 
Designation  M.S. Scholar 
Affiliation  Madan Mohan Malviya Government Ayurved College, Udaipur(313001), Rajasthan, India 
Address  P.G. Department of Shalakya Tantra Madan Mohan Malviya Government Ayurved College and Hospital Near Radaji Circle Udaipur, O.P.D. No. 9 & 10 Udaipur Rajasthan 313001 India
P.G. Department of Shalakya Tantra Madan Mohan Malviya Government Ayurved College and Hospital Near Radaji Circle Udaipur, O.P.D. No. 9 & 10 Udaipur Rajasthan 313001 India
Udaipur
RAJASTHAN
313001
India 
Phone  9462388823  
Fax    
Email  rishabh.sikarwal@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Gulab Chand Bairwa 
Designation  Professor & HOD 
Affiliation  Madan Mohan Malviya Government Ayurved College, Udaipur(313001), Rajasthan, India 
Address  P.G. Department of Shalakya Tantra Madan Mohan Malviya Government Ayurved College and Hospital Near Radaji Circle Udaipur, O.P.D. No. 9 & 10 Udaipur Rajasthan 313001 India
P.G. Department of Shalakya Tantra Madan Mohan Malviya Government Ayurved College and Hospital Near Radaji Circle Udaipur, O.P.D. No. 9 & 10 Udaipur Rajasthan 313001 India
Udaipur
RAJASTHAN
313001
India 
Phone  9460353407  
Fax    
Email  bairwaboss75@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Gulab Chand Bairwa 
Designation  Professor & HOD 
Affiliation  Madan Mohan Malviya Government Ayurved College, Udaipur(313001), Rajasthan, India 
Address  P.G. Department of Shalakya Tantra Madan Mohan Malviya Government Ayurved College and Hospital Near Radaji Circle Udaipur, O.P.D. No. 9 & 10 Udaipur Rajasthan 313001 India
P.G. Department of Shalakya Tantra Madan Mohan Malviya Government Ayurved College and Hospital Near Radaji Circle Udaipur, O.P.D. No. 9 & 10 Udaipur Rajasthan 313001 India
Udaipur
RAJASTHAN
313001
India 
Phone  9460353407  
Fax    
Email  bairwaboss75@gmail.com  
 
Source of Monetary or Material Support  
P.G. Department of Shalakya Tantra Madan Mohan Malviya Government Ayurved College and Hospital Near Radaji Circle Udaipur Udaipur Rajasthan 313001 India 
 
Primary Sponsor  
Name  Madan Mohan Malviya Government Ayurved College Udaipur Rajasthan 
Address  Madan Mohan Malviya Government Ayurved College, Udaipur(313001), Rajasthan, India 
Type of Sponsor  Government medical college 
 
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 
Dr Rishabh Sikarwal  Madan Mohan Malviya Government Ayurved College and Hospital, Udaipur  O.P.D. No. 9 & 10, P.G. Department of Shalakya Tantra, Madan Mohan Malviya Government Ayurved College and Hospital, Udaipur, Rajasthan Udaipur Rajasthan India
Udaipur
RAJASTHAN 		 9462388823

rishabh.sikarwal@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE M.M.M. Govt. Ayurved College Ambamata Udaipur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:H00-H59||Diseases of the eye and adnexa. Ayurveda Condition: SUSHKAKSHIPAKAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-AScyotanam, आश्च्योतनम् (Procedure Reference: Ashtanga hridayam Sutrasthana 23/1, Procedure details: 10 drops of medicine is administered into open eye from a height of two angulas (approximately 3 cm).)
(1) Medicine Name: Go- Ghrita, Reference: Sushruta Sutrasthana 45/97, Route: Ocular, Dosage Form: Ghrita, Dose: 10(drops), Frequency: od, Duration: 30 Days
2Intervention ArmDrugClassical(1) Medicine Name: Shadanga Guggulu, Reference: Chakradutta Netraroga Chikitsa 59/42, Route: Oral, Dosage Form: Guggulu , Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -Luke warm water), Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients using computer or any visual display terminal at least 3 hours per day presenting with clinical features of
1.Netrayasa (Eye strain)
2.Avila Darshana (Blurred vision)
3.Shiro abhitapa (Headache)
4.Netra raga (conjunctival congestion)
5.Netra Daha (Burning sensation)
6.Vishushkatva (Dryness)
7.Slow refocusing
8.Excessive fatigue (Neck/Shoulder/Back pain)
 
 
ExclusionCriteria 
Details  1.Patients suffering from symptoms of dry eye due to causes other than excess exposure to visual display terminals.
2.Patients suffering from systemic illness or taking medications which are known to affect tear quantity and quality.
3.Complicated case with acute/chronic infective infections of lid, conjunctiva, cornea and sclera.  
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Improvement in signs and symptoms of Shushkakshipaka w.s.r. to Computer Vision Syndrome(CVS) after treatment.  30 days. 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in other associated symptoms.  15th day, 30th 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   Phase 2/ Phase 3 
Date of First Enrollment (India)   01/04/2025 
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="0"
Months="1"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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   This is a clinical trial to compare efficacy of Go- Ghrita Aschyotana  and Shadanga Guggulu on Shushkakshipaka with special reference to Computer Vision Syndrome. In this trial 2 groups each of 30 patients will be selected. Group A will be administered with Go-Ghrita Ashchyotana and oral administration of Shadanga Guggulu Vati 2 BD with lukewarm water along with counseling for changing the working style and standard. Group B will be administered with Go-Ghrita Ashchyotana only. 
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