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CTRI Number  CTRI/2020/11/029057 [Registered on: 11/11/2020] Trial Registered Prospectively
Last Modified On: 29/03/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Biological
Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A clinical study to see the effect of some Ayurvedic formulation in the form of nasal administration in the treatment of simple myopia. 
Scientific Title of Study   COMPARATIVE CLINICAL TRIAL TO EVALUATE THE EFFICACY OF BHRINGRAJA TAILA NASYA AND ABHIJIT TAILA NASYA IN THE PRATHAM DWITIY PATALAGATA TIMIR 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vd Sneha Suryakant Air 
Designation  MS Scholar Shalakyatantra (Ayurved) 
Affiliation  Sumatibhai Shah Ayurved Mahavidyalaya 
Address  OPD no. 09, Department of Shalakyatantra, Sane Guruji Arogya Kendra, Malwadi road, Hadapsar, Pune
Department of Shalakyatantra, MAMs Sumatibhai Shah Ayurved College, Hadapsar, Pune
Pune
MAHARASHTRA
411028
India 
Phone  8379999327  
Fax    
Email  snehaair2912@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR PRAVIN M BHAT 
Designation  Associate Professor 
Affiliation  Sumatibhai Shah Ayurved Mahavidyalaya 
Address  OPD no. 09, Department of Shalakyatantra, Sane Guruji Arogya Kendra, Malwadi road, Hadapsar, Pune
Department of Shalakyatantra, MAMs Sumatibhai Shah Ayurved College, Hadapsar, Pune
Pune
MAHARASHTRA
411028
India 
Phone  09860233173  
Fax    
Email  vdpravin82@gmail.com  
 
Details of Contact Person
Public Query  
Name  DR PRAVIN M BHAT 
Designation  Associate Professor 
Affiliation  Sumatibhai Shah Ayurved Mahavidyalaya 
Address  OPD no. 09, Department of Shalakyatantra, Sane Guruji Arogya Kendra, Malwadi road, Hadapsar, Pune
Department of Shalakyatantra, MAMs Sumatibhai Shah Ayurved College, Hadapsar, Pune
Pune
MAHARASHTRA
411028
India 
Phone  09860233173  
Fax    
Email  vdpravin82@gmail.com  
 
Source of Monetary or Material Support  
Department of Shalakyatantra, Sane Guruji Hopsital, Malwadi road, Hadapsar, Pune 
 
Primary Sponsor  
Name  Sane Guruji Arogya Kendra 
Address  Sane Guruji Arogya kendra, Malwadi road, Hadapsar, Pune. 
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 
Vd Sneha Suryakant Air  Sane Guruji Hospital  Malwadi road, Hadapsar, Pune-411028
Pune
MAHARASHTRA 		 8379999327

snehaair2912@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H521||Myopia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Abhijit Taila  It is a formulation of Ayurvedic herbs prepared in the form of Taila for Nasal administration(Nasya) having combination of Amalaki,Yashtimadhu,Godugdha (Cows milk), Tila Taila which will be administered for Nasya 2 bindu (1ml)in each nostril in morning once in a day for 21 days 
Intervention  Bhringaraja Taila  It is a formulation of Ayurvedic herbs prepared in the form of Taila for Nasal administration(Nasya) having combination of Bhringaraja,Yashtimadhu,Godugdha (Cows milk), Tila Taila which will be administered for Nasya 2 bindu (1ml)in each nostril in morning once in a day for 21 days  
 
Inclusion Criteria  
Age From  19.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  1) Patient having signs and symptoms of
Prathama and Dwitiya Patalagata
Timir a will be included i.e blurriness, difficult to distant vision, visual
hallucination.
2) The patient of age from 19 to 40 years,irrespective of gender
3) Patient who have low myopia
3D in both eyes.
4)Patients having a vision 6/9
or less i.e. 6/12, 6/18, 6/24, 6/36, 6/60
5) Patient
yogya for Nasya karma 
 
ExclusionCriteria 
Details  1) Know case of Myopia associated with other ocular diseases such as Cataract glaucoma, Retinal diseases, Iridocyclitis, Vitreous opacity, Chorioretinitis.
2) Know case of Congenital Myopia, Pathological Myopia and other types of Myopia.
3) Patients suffering from infectious diseases e.g. bacterial,viral or Fungalconjunctivitis, Blepharitis, Tubercular infection.
4) Refractive errors like Hypermetropia, Astigmatism.
5) Patients having refractive error more than -3D in both eyes
6) Patients having known case of Diabetes Mellitus, Hypertension, HIV,HBSAg Tuberculosis, Thyroid disorder. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
A clinical study to evaluate efficacy of Bhingaraja Taila Nasya in Prathama and Dwitiya Patalgata Timir w.r.t Simple Myopia. Parameter of efficacy will be visual acuity before and after treatment  Duration of therapy is 3 weeks for each patient and the total duration of trial is 18 month 
 
Secondary Outcome  
Outcome  TimePoints 
comparison between efficacy
of Bhringaraja Taila Nasya and Abhijit Taila Nasya in
Prathama and Dwitiya Patalgata Timir w.r.t
Simple Myopia 		 Each patiennt will receive therapy for 3 weeks. Total duration of the study will 18 months. 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
Final Enrollment numbers achieved (Total)= "74"
Final Enrollment numbers achieved (India)="74" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   01/03/2021 
Date of Study Completion (India) 26/08/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
This study is open labelled randomized comparative clinical trial to evaluate the effect of Bhringaraja Taila Nasya daily in the morning for 21 days in comparison with Abhijit Taila Nasya daily in the morning for 21 days in patients affected with Prathama and Dwitiya Patalagata Timir w.r.t Simple Myopia. The Primary outcome will be effect of Bhringaraja Taila Nasya on visual acuity and the secondary outcome will be comparison between the effect of trial drug and control drug in management of Prathama and Dwitiya Patalagata Timir w.r.t Simple Myopia.
 
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