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CTRI Number  CTRI/2024/07/071008 [Registered on: 22/07/2024] Trial Registered Prospectively
Last Modified On: 13/07/2024
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 to see the efficacy of Vasa Ghee and Triphala Ghee in the management of Simple Myopia by tarpana procedure (ghee will be poured in an enclosure built around the eye out of wheat flour in such that the eyelashes will be dipping). 
Scientific Title of Study   Randomized controlled clinical trial to study efficacy of Vasa Ghrita Tarpana and Triphala Ghrita Tarpana in the management of 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 Sayali Patil 
Designation  MS Scholar Shalakyatantra 
Affiliation  Tilak Ayurveda Mahavidyalaya 
Address  Department of Shalakyatantra 2nd floor Tilak ayurveda Mahavidyalaya 583/2 Rasta Peth Pune

Pune
MAHARASHTRA
411011
India 
Phone  9284020416  
Fax    
Email  patilsayli82@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

Pune
MAHARASHTRA
411011
India 
Phone  9822082795  
Fax    
Email  salvisangeeta@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Sayali Patil 
Designation  MS Scholar Shalakyatantra 
Affiliation  Tilak Ayurveda Mahavidyalaya 
Address  Department of Shalakyatantra 2nd floor Tilak ayurveda Mahavidyalaya 583/2 Rasta Peth Pune

Pune
MAHARASHTRA
411011
India 
Phone  9284020416  
Fax    
Email  patilsayli82@gmail.com  
 
Source of Monetary or Material Support  
Seth Tarachand Ramnath Charitable Ayurvedic Hospital, 580/2, rasta peth, Pune - 411011, Maharashtra, india 
 
Primary Sponsor  
Name  Tilak Ayurveda Mahavidyalaya 
Address  Tilak Ayurveda Mahavidyalaya Rasta Peth Pune - 411011, Maharashtra, india 
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 Sayali Patil  Seth Tarachand Ramnath Ayurvedic Hospital Pune  Department of Shalakyatantra Netra Opd 14 1st floor Rasta Peth Pune 411011 Pune MAHARASHTRA
Pune
MAHARASHTRA 		 9284020416

patilsayli82@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Instituitional ethical committe  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:H00-H59||Diseases of the eye and adnexa. Ayurveda Condition: TIMIRAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-netratarpaNam, नेत्रतर्पणम् (Procedure Reference: Sushrut Uttartantra 18, Procedure details: Patient will be asked to sleep in supine position then the eyes are encircled with firm , compact 2 Angul leakproof pali made up of black gram flour. The Ghrita will be poured in that Pali in such a way that the eyelashes will be dipping. Akshi Tarpana will be retained for the time according to Dosha involved in it.)
(1) Medicine Name: Vasa Ghrita, Reference: Ashtang Hridyay Chikitsa 2/42-44, Route: Ocular, Dosage Form: Ghrita, Dose: 15(ml), Frequency: od, Duration: 3 Months
2Comparator ArmProcedure-netratarpaNam, नेत्रतर्पणम् (Procedure Reference: Sushrut Uttartantra 18, Procedure details: Patient will be asked to sleep in supine position then the eyes are encircled with firm, compact 2 Angul leakproof pali made up of black gram flour. The Ghrita will be poured in that Pali in such a way that the eyelashes will be dipping. Akshi Tarpana will be retained for the time according to Dosha involved in it.)
(1) Medicine Name: Triphala Ghrita , Reference: Ashtang Hridyay Uttartantra 13/10-11, Route: Ocular, Dosage Form: Ghrita, Dose: 15(ml), Frequency: od, Duration: 3 Months
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  25.00 Year(s)
Gender  Both 
Details  Simple Myopia
Spherical No.:- -0.25 to -3.00D 
 
ExclusionCriteria 
Details  Other clinical types of Timira like Cataract,Glaucoma,Presbyopia,Hypermetropia will be excluded. 
 
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 
Decrease in Headache, Eyestrain
, Blurring of Vision 		 30 days and 60 days 
 
Secondary Outcome  
Outcome  TimePoints 
Decrease in Blurring of Vision  90 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 3 
Date of First Enrollment (India)   26/07/2024 
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   N/A 
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 Vasa Ghrita Tarpana and Triphala Ghrita Tarpana 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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