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CTRI Number  CTRI/2024/07/070335 [Registered on: 09/07/2024] Trial Registered Prospectively
Last Modified On: 04/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Use and effect of Rasanjana and Trataka karma on vision 
Scientific Title of Study   An observational study on physiological effect of Rasanjana and Trataka karma on vision 
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 Twinkal Parmar 
Designation  PG Scholar Kriya sharira 
Affiliation  Madan Mohan Malaviya Government Ayurved College Amba mata Radaji circle Udaipur 313001 Rajasthan 
Address  Department of Kriya sharira MMM Government Ayurveda College Udaipur Rajasthan

Udaipur
RAJASTHAN
313001
India 
Phone  9428026223  
Fax    
Email  twinkalparmar1399@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ashok Kumar Sharma 
Designation  Professor & HOD of Kriya sharira 
Affiliation  MMM Government Ayurveda College Udaipur 
Address  Department of Kriya sharira MMM Government Ayurveda College Udaipur Rajasthan

Udaipur
RAJASTHAN
313001
India 
Phone  9413205904  
Fax    
Email  sharmadrak06@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Ashok Kumar Sharma 
Designation  Professor & HOD of Kriya sharira 
Affiliation  MMM Government Ayurveda College Udaipur 
Address  Department of Kriya sharira MMM Government Ayurveda College Udaipur Rajasthan

Udaipur
RAJASTHAN
313001
India 
Phone  9413205904  
Fax    
Email  sharmadrak06@gmail.com  
 
Source of Monetary or Material Support  
Madan Mohan Malaviya Government Ayurveda College Amba mata Radaji circle Udaipur- 313001 Rajasthan 
 
Primary Sponsor  
Name  MMM Government Ayurveda College Udaipur Rajasthan 
Address  Madan Mohan Malaviya Government Ayurveda College Amba mata Radaji circle Udaipur- 313001 Rajasthan 
Type of Sponsor  Government 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 Twinkal Parmar  Shree S.S.B. Govt. Satellite Hospital  OPD NO. 20 OPHTHALMOLOGIST Shree S.S.B. Govt. Satellite Hospital Amba mata Udaipur-313001
Udaipur
RAJASTHAN 		 9428026223

twinkalparmar1399@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee MMM Government Ayurved College Udaipur  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
1Comparator ArmProcedure-Trataka karma (Procedure Reference: घेरण्ड संहिता. 1/55, Procedure details: Keep the eye open at the same level of stand blowing candle and focus on that candle until lacrimation)
2Intervention ArmProcedure-rasA~jjanam, रसाऽज्जनम् (Procedure Reference: अ.ह्र.सू. 23/26, Procedure details: After applying Rasāñjana, without opening of eye move the eyeball inside the eye like up down, right left until lacrimation stop. During this time blinking of eye, pressing of eye should not be done. After that eye wash is also denied. )
(1) Medicine Name: Rasanjana, Reference: च.सू.5/15, Route: Ocular, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 1(NA), Frequency: od, Duration: 18 Days
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  Age - 16 to 40 years
Person having symptoms like Headache, Lacrimation, Fatigue of eyes, Heaviness in eyes, Pain in eyes, Dryness of eyes etc.
Refractive error - Physiological myopia (≤ -3 D)
 
 
ExclusionCriteria 
Details  Age above 16 and below 40 years
Contraindicated for Añjana
Any ocular disease which decreases the vision like Cataract, Glaucoma, Pterygium etc.
Diabetes Mellitus and Hypertension and any other chronic disease.
 
 
Method of Generating Random Sequence   Adaptive randomization, such as minimization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Improvement in sign and symptoms of vision  90 days  
 
Secondary Outcome  
Outcome  TimePoints 
Efficacy of treatment (Rasanjana & Trataka karma)  30 days, 60 days & 90 days 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)
Modification(s)  		 01/01/2025 
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
Modification(s)  		 Years="0"
Months="11"
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   This study is an observational study on physiological effect of Rasāñjana and Trāṭaka karma  on vision. This study will be conducted in 2 groups.
In Group A - Rasāñjana will be given.
In Group B -Trāṭaka karma will be performed.
Each group consist of 50 randomly selected patients as per inclusion and exclusion criteria. 
Rasāñjana will be prepared as per classical method mentioned in Bhavaprakash Samhita.
Bahiranga Trāṭaka will be performed in group B until lacrimation.
Trial will be conducted for 3 months. Follow up of the patient will be taken after every 30 days or 1 month. Total 3 follow up of patient will be taken during treatment.
Final assessment will be done after completion of 3 month treatment course on the basis of subjective and objective assessment.
Then the data will be analyzed scientifically and statistically.
 
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