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CTRI Number  CTRI/2024/07/070150 [Registered on: 08/07/2024] Trial Registered Prospectively
Last Modified On: 20/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Panchakarma procedure and Ayurvedic medicine in the management of Timira (Simple Myopia) 
Scientific Title of Study   A comparative study to evaluate the efficacy of Maha Triphaladya Ghrita Akashi Tarpana with and without Netrashani Rasa in the management of Timira w.r.s to Simple Myopia  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr. Rishabh Singh  
Designation  PG scholar (Deptt. of Panchakarma) 
Affiliation  Dayanand Ayurvedic College, Jalandhar 
Address  Dayanand Ayurvedic College, Mahatma Hans Raj Marg, Jalandhar, Punjab

Jalandhar
PUNJAB
144008
India 
Phone  9877521512  
Fax    
Email  drrishabhsingh45@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Parveen Kumar 
Designation  Associate Professor (Deptt. of Panchakarma) 
Affiliation  Dayanand Ayurvedic College, Jalandhar 
Address  Dayanand Ayurvedic College, Mahatma Hans Raj Marg, Jalandhar, Punjab

Jalandhar
PUNJAB
144008
India 
Phone  7589303536  
Fax    
Email  drprav1@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr. Rishabh Singh 
Designation  PG scholar (Deptt. of Panchakarma) 
Affiliation  Dayanand Ayurvedic College, Jalandhar 
Address  Dayanand Ayurvedic College, Mahatma Hans Raj Marg, Jalandhar, Punjab

Jalandhar
PUNJAB
144008
India 
Phone  9877521512  
Fax    
Email  drrishabhsingh45@gmail.com  
 
Source of Monetary or Material Support  
Dayanand Ayurvedic College, Mahatma Hans Raj Marg, Gurdev Nagar, Dayanand Nagar, Jalandhar, Punjab, India Pin code-144008 
 
Primary Sponsor  
Name  Dayanand Ayurvedic college Hospital  
Address  Department of Panchakarma, Dayanand Ayurvedic College, Mahatma Hans Raj Marg, Gurdev Nagar, Dayanand Nagar, Jalandhar, Punjab, India Pin code-144008 
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 Rishabh Singh   Dayanand Ayurvedic College  Department of Panchakarma, Mahatma Hans Raj Marg, Jalandhar,144008
Jalandhar
PUNJAB 		 9877521512

drrishabhsingh45@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Dayanand Anglo Vedic Institutional Ethics Committee  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 ArmProcedure-netratarpaNam, नेत्रतर्पणम् (Procedure Reference: Sharangdhar Samhita, Procedure details: 1 Supine position will be given to the patient in a room space, providing it should be away from direct sunlight, wind & dust. Tarpana will be given after mild fomentation with cotton soaked in lukewarm water, then the eyes will be encircled with firm, compact wall made up of paste of powdered mash (black gram lentils). The height of this wall should be 2 Angula. 2 The patient has to close the eyes & over the closed eyes, liquefied Ghrita will be poured very slowly till the entire eyelash))
(1) Medicine Name: Mahatriphaladya Ghrita , Reference: Ayurvedic formulatory of India, Part 1, Route: Ocular, Dosage Form: Ghrita, Dose: 15(ml), Frequency: od, Duration: 15 Days
(2) Medicine Name: Netrashani Ras, Reference: Rasendra sara sangraha, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 125(mg), Frequency: bd, Duration: 45 Days
2Comparator ArmProcedure-netratarpaNam, नेत्रतर्पणम् (Procedure Reference: Sharangdhar Samhita, Procedure details: 1 Supine position will be given to the patient in a room space, providing it should be away from direct sunlight, wind & dust. Tarpana will be given after mild fomentation with cotton soaked in lukewarm water, then the eyes will be encircled with firm, compact wall made up of paste of powdered mash (black gram lentils). The height of this wall should be 2 Angula. 2 The patient has to close the eyes & over the closed eyes, liquefied Ghrita will be poured very slowly till the entire eyelash))
(1) Medicine Name: Mahatriphaladya Ghrita , Reference: Ayurvedic formulatory of India, Part 1, Route: Ocular, Dosage Form: Ghrita, Dose: 15(ml), Frequency: od, Duration: 15 Days
 
Inclusion Criteria  
Age From  14.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  1 All the patients fulfilling the diagnostic criteria and having Low and Moderate degree of myopia will be included in the study.
2 The patient having age between 14 to 45 years old, will be selected for study.
3 The patient willing to participate in the study. 
 
ExclusionCriteria 
Details  1 Patient not willing for registration.
2 Patients outside age group of 14 to 45 years.
3 Refractive media pathologies and Cases complicated
with infection and corneal ulcer etc.
4 Other systemic or metabolic disorders. 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1 To Study the effect of Akashitarpana with Mahatriphalyadi Ghritam in the management of Timira w.r.s to Simple Myopia
2 To Compare the difference of efficacy of Akashitarpana with or without Netrashani Rasa. 		 60 Days 
 
Secondary Outcome  
Outcome  TimePoints 
To provide economic, easily manageable, permanent and adverse affect free treatment for timira.  60 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/ Phase 3 
Date of First Enrollment (India)   30/07/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  30/07/2024 
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   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   In this clinical trial total 60 patients will be selected, these 60 patients will be divided into to group (Group A and Group B). Group A will be given Akashitarpana with Maha Triphaladya Ghrita along with Netrashani Rasa and Group B will be given only Akashitarpana with Maha Triphaladya Ghrita and will conduct to study the effect of Akashitarpana with Mahatriphalyadi Ghritam in the management of Timira w.r.s to Simple Myopia and to Compare the difference of efficacy of Akashitarpana with or without Netrashani Rasa. Total duration of study will be 18 months. 
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