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CTRI Number  CTRI/2022/11/047345 [Registered on: 16/11/2022] Trial Registered Prospectively
Last Modified On: 15/11/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Other 
Public Title of Study   Ayurvedic medicine in the management of blurred vision 
Scientific Title of Study   Development, Standardization and Clinical validation of Nayana Sukha Varti Ointment Anjana in Simple Myopia- Open labelled single group clinical trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Srinidhi S 
Designation  PG Scholar 
Affiliation  KAHER Shri B M Kankanwadi Ayurveda mahavidyalaya Shahapur Belagavi  
Address  Department of Shalakya Tantra KAHER Shri B M Kankanwadi Ayurveda mahavidyalaya Shahapur Belagavi

Belgaum
KARNATAKA
590003
India 
Phone  6380238349  
Fax    
Email  srinidhi.janani@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Arunkumar Bapurao Biradar 
Designation  Associate professor 
Affiliation  KAHER Shri B M Kankanwadi Ayurveda mahavidyalaya Shahapur Belagavi 
Address  Department of Shalakya Tantra KAHER Shri B M Kankanwadi Ayurveda mahavidyalaya Shahapur Belagavi

Belgaum
KARNATAKA
590003
India 
Phone  9964064955  
Fax    
Email  arunkumar.biradar@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Arunkumar Bapurao Biradar 
Designation  Associate professor 
Affiliation  KAHER Shri B M Kankanwadi Ayurveda mahavidyalaya Shahapur Belagavi 
Address  Department of Shalakya Tantra KAHER Shri B M Kankanwadi Ayurveda mahavidyalaya Shahapur Belagavi

Belgaum
KARNATAKA
590003
India 
Phone  9964064955  
Fax    
Email  arunkumar.biradar@gmail.com  
 
Source of Monetary or Material Support  
KAHER Shri B M Kankanwadi Ayurveda Mahavidyalaya and Hospital Shahapur Belagavi 
 
Primary Sponsor  
Name  Dr Srinidhi S 
Address  PG Scholar Department of Shalakya Tantra KAHER Shri B M Kankanwadi Ayurveda Mahavidyalaya Shahapur BelagaviBelagavi 590003 
Type of Sponsor  Other [Self ] 
 
Details of Secondary Sponsor  
Name  Address 
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 Srinidhi S  KAHERS Shri B M Kankanwadi Ayurveda Mahavidyalaya Shahapur Belagavi  OPD No 27 Department of Shalakya Tantra KLE Ayurveda Hospital and MRC Shahapur Belagavi
Belgaum
KARNATAKA 
6380238349

srinidhi.janani@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICAL COMMITTEE FOR RESEARCH ON HUMAN SUBJECTS  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: TIMIRAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-a~jjanam, अंजनम् (Procedure Reference: bhaishajya ratnavali chapter 64 netra roga adhikara shloka number 196, Procedure details: the prepared nayana sukha varti anjana ointment will be applied in both the eyes of the patient from kaninaka sandhi to apanga sandhi once a day for a period of 21 days)
(1) Medicine Name: Nayana sukha varti , Reference: bhaishajya ratnavali chapter 64 netra roga adhikara shloka number 196, Route: Ocular, Dosage Form: Malahara/ Ointment/ Balm, Dose: 1(g), Frequency: od, Duration: 21 Days
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  25.00 Year(s)
Gender  Both 
Details  a SUBJECTS HAVING REFRACTIVE ERROR WITHIN -3 D
b SUBJECTS OF EITHER SEX
c FROM 16 YEARS TO 25 YEARS OF AGE 
 
ExclusionCriteria 
Details  a ANY ALLERGIC CONDITIONS
b METABOLIC DISORDERS
c ANY SEVERE EYE AILMENTS 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
VISUAL ACUITY LOG MAR REFRACTION  Baseline and 21st day 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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 4 
Date of First Enrollment (India)   20/11/2022 
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="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  

Globally, 2.2 billion people have distance vision impairment.The prevalence of myopia in 5 to 15 years old urban children increased from 4.44% in 1999 to 21.15% in 2019. Myopia is a commonest clinical condition in which the refracted light spectrum from all possible direction forms an image before / in front of retina. This situation induces blurry vision & related clinical features. Concept of Refractive Errors nearly correlates with Timira. It is a conduction explained in classics starting from minimal visual blurriness to visual hallucinations, delusions, abrasions, etc. Spectacles, contact lenses, Ortho-optic treatment, few medications, suppliments and surgical intervention are treatment options available. Various systemic and local therapies in the form of Kriyakalpa procedures like Aschyotana, Seka, Anjana, etc are explained for vision enhancement. Nayana Sukha Varti is a classical formulation of Anjana from Bhaishajya Ratnavali indicated in Timira. In Anjana procedure, it is advised to rub Varti with suitable media and applied from medial to lateral canthus with various metallic applicator.This leads to controversy in its sterility, stability, utility, therapeutic efficacy, application method, applicator, storage method, etc. In such scenario there is a need of safe and sterile form of medication without compromising pharmaceutical as well as clinical values. Thus this new technique of Anjana preparation checks out the challenging hurdles in Anjana practices. This modified form of Anjana preparation should be equivalent and competent to modern opthalmic preparations. 

 

 
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