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CTRI Number  CTRI/2022/02/040497 [Registered on: 22/02/2022] Trial Registered Prospectively
Last Modified On: 21/02/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Ayurvedic Management of Simple Myopia using Patoladi Ghrita for Aschyotana and Internally 
Scientific Title of Study   A Clinical Study on Patoladi Ghrita Achyotana and Pana in the managaement of Prathama patalagatha timira(SIMPLE MYOPIA) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Anuja K Simon 
Designation  PG scholar 
Affiliation  SDM College of Ayurveda, Hassan 
Address  Department of Shalakya tantra Sri Dharmasthala Manjunatheshwara Ayurveda College Thanniruhalla , Hassan

Hassan
KARNATAKA
573201
India 
Phone  9447742938  
Fax    
Email  anujaselin@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Gururaj Anil Bhat 
Designation  Assistant Professor 
Affiliation  SDM College of Ayurveda, Hassan 
Address  Department of Shalakya tantra Sri Dharmasthala Manjunatheshwara Ayurveda College Thanniruhalla , Hassan

Hassan
KARNATAKA
573201
India 
Phone  9880856916  
Fax    
Email  drgururajanilbhat@sdmcahhassan.org  
 
Details of Contact Person
Public Query  
Name  Anuja K Simon 
Designation  PG scholar 
Affiliation  SDM College of Ayurveda, Hassan 
Address  Department of Shalakya tantra Sri Dharmasthala Manjunatheshwara Ayurveda College Thanniruhalla , Hassan


KARNATAKA
573201
India 
Phone  9447742938  
Fax    
Email  anujaselin@gmail.com  
 
Source of Monetary or Material Support  
Department of Shalakyatantra opd, Sri Dharmasthala Manjunatheshwara Ayurveda hospital , BM Road , Thanniruhalla, Hassan 
 
Primary Sponsor  
Name  Dr Anuja K Simon 
Address  Department of Shalakyatantra Sri Dharmasthala Manjunatheswara college of Ayurveda and Hospital Thanniruhalla BM Road Hassan Karnataka 573201 
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 Anuja K Simon  Sri Dharmastala Manjunatheswara college of ayurveda and hospital  Shalakya Opd room no 13 Department of Shalakyatantra Sri Dharmasthala Manjunatheshwara Ayurveda College and hospital Thanniruhalla BM road Hassan 573201
Hassan
KARNATAKA 		 9447742938

anujaselin@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SRI DHARMASTHALA MANJUNATHESHWARA COLLEGE OF AYURVEDA AND HOSPITAL, HASSAN  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:H521||Myopia. Ayurveda Condition: TIMIRAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Patoladi Ghrita, Reference: Ashtanga Hrudaya Uttara sthana, Route: Oral, Dosage Form: Ghrita, Dose: 15(ml), Frequency: hs, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: none
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  25.00 Year(s)
Gender  Both 
Details  Patient complaints of difficulty in distant vision. (-0.5 D to -6D)
Patients in the age group of 5-25 years
Patients who are ready to sign an informed consent form and parent assent form (for minors) 
 
ExclusionCriteria 
Details  Pathological myopia, high myopia with degenerative and retinal changes associated with
endocrinal and nutritional disorder.
Myopia associated with neighboring structural deformation like cataract, corneal opacity.
Patients suffering from any of the systemic disorders such as hypertension, diabetes, tuberculosis,
syphilis etc 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To evaluate changes in best corrected visual
acuity 		 Baseline assesement 1st day 15th day 30 th day and 60 th day 
 
Secondary Outcome  
Outcome  TimePoints 
To improve the vision after 8 weeks  To improve the vision after 8 weeks 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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   N/A 
Date of First Enrollment (India)   28/02/2022 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [anujaselin@gmail.com].

  6. For how long will this data be available start date provided 31-03-2022 and end date provided 07-03-2027?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary  

SUMMARY-

Timira is one among the eye diseases that starts with blurred vision and ends in complete loss of vision. Prathama patalagatha Timira is the initial condition which is characterized by blurred vision. It can be correlated to simple myopia which has similar symptoms. The treatment should aim to improve the clarity of vision of patients. Aschyothana is the first line of treatment in eye disease by acharyas where 80% of medicines will be drained into nasolacrimal duct through punctum which maintain integrity of drainage. In Astanga hridaya, Patoladi gritha is effective in the treatment of timira. Drugs in Patoladi gritha are said to possess the properties of kaphapitta shamaka, rasayana and chakshushya. In this study, an effort has been made to evaluate the efficacy of Patoladi gritha Aschyothana and Pana in the management of simple myopia.

 

 

OBJECTIVES-

 

1.. To evaluate the effectiveness of Patoladi gritha Aschyothana and Pana in the management of Prathama patalagatha Timira (simple myopia).

 

METHODOLOGY-

 

a.     METHODOLOGY: Interventional clinical study, Data will be collected using specially prepared case report forms by incorporating all the aspects of objective methodology.

 

 

RESEARCH DESIGN

 

The current study will be conducted based on a convenient sampling method on an open label single arm prospective interventional clinical study with pre and post-test design.

 

SOURCE OF DATA: Patients fulfilling diagnostic and inclusion criteria will be recruited from the outpatient and inpatient Department of Shalakya tandra, Sri Dharmasthala  Manjunatheshwara College of Ayurveda and Hospital, Hassan.

SAMPLING TECHNIQUE: Convenient sampling

 

SAMPLE SIZE: 30

 

DIAGNOSTIC CRITERIA:

 

A.    The diagnostic criteria will be based on lakshanas of Prathama patalagatha Timira described in Ayurvedic classics as following:

·       Avyaktha darshana (best corrected vision < -6D)

Subjective parameters:

1      Blurred vision

Objective Parameters:

1      Snellen’s Visual acuity chart. (6/6 to 6/60)

2      Autorefractometry (Prestige ORK -CE0120 Made in Korea)

 

 
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