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
|
|
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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition:H539||Unspecified visual disturbance. Ayurveda Condition: TIMIRAH, |
|
Intervention / Comparator Agent
|
sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | 1 | Intervention Arm | Procedure | - | a~jjanam, अंजनमॠ| (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. |