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CTRI Number  CTRI/2025/03/083233 [Registered on: 24/03/2025] Trial Registered Prospectively
Last Modified On: 22/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda
Preventive 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Effect of Eye Exercises (Netra vyayam) in Myopia i.e. short sightedness 
Scientific Title of Study   Randomized open labeled Placebo controlled add on clinical study to assess the efficacy of eye exercises (NETRA VYAYAMA) in the management of Pratham Patalgat timira with and without Abhijita taila nasya with Special reference to 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 Akshata Karale  
Designation  Post Graduation Scholar 
Affiliation  Dr. D Y Patil school of ayurveda , deemed to be university,Nerul, Navi mumbai. 400706 
Address  Opd No. 4 , 1st floor, Department of Shalakyatantra, Dr DY Patil school of ayurveda deemed to be university, Nerul, Navi Mumbai Thane MAHARASHTRA 400706

Thane
MAHARASHTRA
400706
India 
Phone  7709797153  
Fax    
Email  akshukarale14@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ashwini patil 
Designation  Head Of Department , Shalakyatantra department  
Affiliation  D. Y. Patil school of ayurveda deemed to be university 
Address  Shalakya tantra department, D. Y. Patil school of ayurveda deemed to be university, Nerul, Navi Mumbai Thane MAHARASHTRA 400706

Thane
MAHARASHTRA
400706
India 
Phone  8108138018  
Fax    
Email  ashwini.patil@dypatil.edu  
 
Details of Contact Person
Public Query  
Name  Dr Ashwini Patil 
Designation  Head Of Department, Shalakyatantra department  
Affiliation  D. Y. Patil school of ayurveda deemed to be university 
Address  D. Y. Patil school of ayurveda deemed to be university, Nerul, Navi Mumbai Thane MAHARASHTRA 400706 India

Thane
MAHARASHTRA
400706
India 
Phone  8108138018  
Fax    
Email  ashwini.patil@dypatil.edu  
 
Source of Monetary or Material Support  
D. Y. Patil school of ayurveda and ayurvedic hospital, Nerul, Navi Mumbai, Maharashtra, India 400706 
 
Primary Sponsor  
Name  D Y Patil school of ayurveda deemed to be university 
Address  D. Y. Patil school of ayurveda deemed to be university, Nerul, Navi Mumbai,Maharashtra, India 400706 
Type of Sponsor  Research institution and hospital 
 
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 Akshata karale  Dr. D Y Patil school of Ayurveda and Hospital  OPD no 4,first floor, Department of shalakyatantra, Dr. D Y Patil school of ayurveda deemed to be university, Nerul, Navi Mumbai, 400706 Maharashtra India Thane MAHARASHTRA
Thane
MAHARASHTRA 		 07709797153

akshukarale14@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee, D.Y.Patil school of ayurveda deemed to be university Nerul Navi Mumbai  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: PRATHAMA-PATALAGATADOSHAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmLifestyle--Dinacarya: , Ritucarya: , Acara Rasayana:, Other:Netra vyayama( eye exercise), Pathya/Apathya:no, Pathya:, Apathya:
2Comparator ArmProcedure-nasyam/ nastam, नस्यम्/ नस्तम् (Procedure Reference: Su.chi.40/21, Procedure details: 2 drops of abhijita taila nasal drop in each nostril at pratahkaal after mutrochhar)
(1) Medicine Name: Abhijita taila, Reference: Chakradatta 59/189-140 , bhaishajya ratnavali netrarogadhikaar 264-265, Route: Nasal, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 2(drops), Frequency: od, Duration: 3 Months
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  28.00 Year(s)
Gender  Both 
Details  1) Myopia less than or equal to -3D
2) Patient of either sex between 18-28 years of age
3)Patients willing to participate in the study and ready to give written consent 
 
ExclusionCriteria 
Details  1)Myopia greater than -3D
2) Age group less than 18 and greater than 28years of age
3)Patient who have undergone ocular surgery and has association with systematic diseases, debilitating diseases and immuno-compromised diseases
4) Patients who have ocular pathology such as amblyopia, strabismus or glaucoma
5) Patients who are failed to give consent
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Avyakta Rupa
Netra Aayasa
Shiroabhitaap
Viisual acuity
Axial length
Keratometry k1 and k2
Dioptric acceptance
 		 3months 
 
Secondary Outcome  
Outcome  TimePoints 
Recurrence of symptoms
Avyakta Rupa
Netra Aayasa
Shiroabhitaap 		 5 month  
 
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 2/ Phase 3 
Date of First Enrollment (India)   04/04/2025 
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   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   Due to increased prevalance myopia has become public health problem in India. As it involves lifelong risk of visual impairment good treatment option for prevention of myopia is necessary. Nowadays younger generation being busy with their studies and office work is not able to devote ample amount of time of time for treatment ir therapy. Hence very good option for treatment of myopia would be Eye exercise and Nasya with Abhijita taila as mentioned in chakradatta. This treatment is safe,easy and cost effective so it can be given as treatment as well as prevention of myopia. 
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