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CTRI Number  CTRI/2023/02/049978 [Registered on: 22/02/2023] Trial Registered Prospectively
Last Modified On: 17/02/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A comparative study of efficacy of Goghrit( cows ghee) Eye drops and Carboxymethyl cellulose artificial tear drops in management of dry eye for mobile vision syndrome.  
Scientific Title of Study   Randomized controlled clinical trial to study the efficacy of Goghrit aschyotana and Carboxymethyl cellulose artificial tear drops in management of dry eye in mobile vision syndrome. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ruchi Lanjewar 
Designation  MS Scholar Shalakyatantra 
Affiliation  Tilak Ayurveda Mahavidyalaya 
Address  Department of Shalakyatantra 2nd floor Tilak ayurveda Mahavidyalaya 583/2 Rasta Peth Pune
583/2 Rasta Peth Pune 411011
Pune
MAHARASHTRA
411011
India 
Phone  8788812254  
Fax    
Email  ruchilanjewar16.1997@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sangeeta Salvi 
Designation  HOD Shalakyatantra Department 
Affiliation  Tilak Ayurveda Mahavidyalaya 
Address  Department of Shalakyatantra 2nd floor Tilak ayurveda Mahavidyalaya 583/2 Rasta Peth Pune
583/2 Rasta Peth Pune 411011
Pune
MAHARASHTRA
411011
India 
Phone  9822082795  
Fax    
Email  salvisangeeta@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Ruchi Lanjewar 
Designation  MS Scholar Shalakyatantra 
Affiliation  Tilak Ayurveda Mahavidyalaya 
Address  Department of Shalakyatantra 2nd floor Tilak ayurveda Mahavidyalaya 583/2 Rasta Peth Pune
583/2 Rasta Peth Pune 411011
Pune
MAHARASHTRA
411011
India 
Phone  8788812254  
Fax    
Email  ruchilanjewar16.1997@gmail.com  
 
Source of Monetary or Material Support  
Seth Tarachand Ramnath Charitable Ayurvedic Hospital Pune  
 
Primary Sponsor  
Name  Tilak Ayurveda Mahavidyalaya 
Address  Tilak Ayurveda Mahavidyalaya Rasta Peth Pune 
Type of Sponsor  Private 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 Ruchi Lanjewar  Seth Tarachand Ramnath Ayurvedic Hospital Pune  Department of Shalakyatantra Netra Opd 14 1st floor Rasta Peth Pune 411011
Pune
MAHARASHTRA 		 8788812254

ruchilanjewar16.1997@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Tilak Ayurveda Mahavidyalaya Pune  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. Ayurveda Condition: NETRAROGAH/AKSHIROGAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-AScyotanam, आश्च्योतनम् (Procedure Reference: Sharangdhar Sanhita Uttarkhand 13/12, Procedure details: Aschyotan is a procedure of instillation of drug in form of drops into the eye from a height of 2 angul. )
(1) Medicine Name: Goghrit, Reference: Sushrut Sanhita Sutrasthan 45/97, Route: Topical, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 10(drops), Frequency: od, Duration: 21 Days
2Comparator Arm (Non Ayurveda)-Carboxymethylcellulose artificial tear dropsCarboxymethylcellulose artificial tears are primary treatment for dry eyes. This is used by topical route and one drop will be administered once a day in morning for 21 days. It is anionic cellulose polymer with a carboxyl group substitution and exhibit good bio adhesive characteristics.
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Patients with signs and symptoms of dry eye in mobile users. 
 
ExclusionCriteria 
Details  Patients undergoes intraoccular or extraoccular surgery in last three months.
Patients already diagnosed with epilepsy, tuberculosis, leprosy, asthama and malignancy.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Sample size 60 decrease in foriegn body sensation, photophobia, eye strain, redness, burning sensation and watery discharge.  21 days 
 
Secondary Outcome  
Outcome  TimePoints 
Decrease in symptoms like foriegn body sensation, photophobia, eye strain, redness, burning sensation and watery discharge in 3 months.  3 months 
 
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 3 
Date of First Enrollment (India)   23/02/2023 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   none yet 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   The study will be intervened by the treatment of Goghrit aschyotana and Carboxymethyl cellulose artificial tear drops to group A and group B respectively. The efficacy of the therapy will be assessed on the basis of subjective criteria for statistical analysis. scoring will be designed according to severity of symptoms. the subjective gradation of symptoms will be done as follows and intensity of each symptoms will be calculated before treatment, after treatment and after follow up. The  effect of treatment result will be assessed in regards to clinical signs and symptoms on basis of grading and scoring system. The signs and symptoms will be assessed by adopting suitable scoring method.   
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