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CTRI Number  CTRI/2020/10/028755 [Registered on: 29/10/2020] Trial Registered Prospectively
Last Modified On: 23/10/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Role of Certain Oral Drug in Computer and Visual Display Terminal Vision Syndrome - CVDTS 
Scientific Title of Study   A Randomized Clinical Trial to Evaluate the Efficacy of Ayurvedic Compound in Shushkakshipaka w.s.r. to Computer and Visual Display Terminal Vision Syndrome (CVDTS) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ashok Kumar 
Designation  Associate Professor 
Affiliation  National institute of Ayurveda  
Address  Dept of Shalya Tantra National Institute of Ayurveda jorawar Singh Gate Amer Road Jaipur

Jaipur
RAJASTHAN
302002
India 
Phone  9649180572  
Fax    
Email  ashok_hp1976@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ashok Kumar 
Designation  Associate Professor 
Affiliation  National institute of Ayurveda  
Address  Dept of Shalya Tantra National Institute of Ayurveda jorawar Singh Gate Amer Road Jaipur


RAJASTHAN
302002
India 
Phone  9649180572  
Fax    
Email  ashok_hp1976@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Ashok Kumar 
Designation  Associate Professor 
Affiliation  National institute of Ayurveda  
Address  Dept of Shalya Tantra National Institute of Ayurveda jorawar Singh Gate Amer Road Jaipur


RAJASTHAN
302002
India 
Phone  9649180572  
Fax    
Email  ashok_hp1976@yahoo.com  
 
Source of Monetary or Material Support  
National institute of Ayurveda Jorawar Singh Gate Amer Road Jaipur Rajasthan 302002 
 
Primary Sponsor  
Name  National Institute of Ayurveda 
Address  Dept of Shalya Tantra National Institute of Ayurveda Jorawar Singh Gate Jaipur  
Type of Sponsor  Research institution and hospital 
 
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 Rajendra Kumar Soni  National institute of Ayurveda  OPD no. 14 P G department of Shalakya Tantra
Jaipur
RAJASTHAN 		 7017970757

vaidya.rajsoni@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
institutional Ethics Committee National institute of Ayurveda  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H041||Other disorders of lacrimal gland,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Chakshushya Ghrita Tarpana, Shadanga Guggulu Vati Orally  1. Purva karma: i) Netra parisheka with 50-60 ml Triphaladi Kwatha in morning for 5 days for Aama pachana ii) Nasya with Anu taila 6 drops in each nostril in morning for 5 days 2. Pradhana karma: Tarpana with Chakshushya Ghrita 20ml per sitting in morning for 5 days The same procedure for each eye will be repeated after a gap of 10 days with 3 consecutive sittings. 3. Shadanga Guggulu Vati 2 tab. (each of 500 mg) twice a day after meal with luke warm water as Anupana for 45 days. 
Comparator Agent  Shadanga Guggulu Vati Orally  Shadanga Guggulu Vati 2 tab. (each of 500 mg) twice a day after meal with luke warm water as Anupana for 45 days. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients using computer 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. NetraDaha (Burning sensation)
6. Vishushkatva (Dryness)
7. Slow refocusing
8. Excessive fatigue (Neck/Shoulder/Back pain)
 
 
ExclusionCriteria 
Details  1. Patient not willing for registration.
2. Patients suffering from symptoms of dry eye due to causes other than excess exposure to visual display terminals.
3. Patients suffering from systemic illness or taking medications which are known to affect tear quantity and quality.
4. Complicated case with acute/chronic infective infections of lid, conjunctiva, cornea and sclera.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Evaluate the efficacy of Ayurvedic compound in computer and visual display terminal vision syndrome (CVDTS) W.S.R. to Shushkakshipaka  45 Days 
 
Secondary Outcome  
Outcome  TimePoints 
Any adverse event reported voluntarily, observed or enquire  45 Days 
 
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 
Date of First Enrollment (India)   02/11/2020 
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="5"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Purpose- To Evaluate the Efficacy of Ayurvedic Compound in Shushkakshipaka w.s.r. to Computer and Visual Display Terminal Vision Syndrome (CVDTS)

GROUP A: Tarpana with Chakshushya Ghrita and oral administration of Shadanga Guggulu Vati

 GROUP B: oral administration of Shadanga Guggulu Vati

 
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