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CTRI Number  CTRI/2021/12/038517 [Registered on: 08/12/2021] Trial Registered Prospectively
Last Modified On: 09/09/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   study held to see the effect of ksheer saindhava closed eye irrigation in the management of simple allergic conjunctivitis 
Scientific Title of Study   "A single arm clinical study to evaluate the efficacy of ksheer Saindhava Pariseka in the management of Vataja Abhishyanda (Simple Allergic Conjunctivitis) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Atri Ghosh 
Designation  PG scholar shalakya Tantra 
Affiliation  Dr D Y Patil College of Ayurved and Research Centre 
Address  Dr D Y Patil College of Ayurved and Research Centre Sant Tukaram Nagar, Pimpri Colony, Maharashtra Pimpri-Chinchwad.

Pune
MAHARASHTRA
411018
India 
Phone  8902909231  
Fax    
Email  sub_ghosh62@rediffmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vikas Kumbhar 
Designation  Professor 
Affiliation  Dr D Y Patil College of Ayurved and Research Centre 
Address  Dr D Y Patil College of Ayurved and Research Centre Sant Tukaram Nagar, Pimpri Colony, Maharashtra Pimpri-Chinchwad.

Pune
MAHARASHTRA
411018
India 
Phone  9730130390  
Fax    
Email  vikasdr50@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Atri Ghosh 
Designation  PG scholar shalakya Tantra 
Affiliation  Dr D Y Patil College of Ayurved and Research Centre 
Address  Dr D Y Patil College of Ayurved and Research Centre Sant Tukaram Nagar, Pimpri Colony, Maharashtra Pimpri-Chinchwad.

Pune
MAHARASHTRA
411018
India 
Phone  8902909231  
Fax    
Email  sub_ghosh62@rediffmail.com  
 
Source of Monetary or Material Support  
Dr. D. Y. Patil College of Ayurved and Research Centre 
 
Primary Sponsor  
Name  Atri Ghosh 
Address  Dr. D. Y. Patil College of Ayurved and Research Centre Sant Tukaram Nagar, Pimpri Colony, Pimpri-Chinchwad, Maharashtra 411018 
Type of Sponsor  Other [Self] 
 
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 
Atri Ghosh  Dr. D. Y. Patil College of Ayurved and Research Centre  Department of Shalakya Tantra,Division- Netra Roga OPD, Ground floor, OPD No-6 Sant Tukaram Nagar, Pimpri Colony, Pimpri-Chinchwad, Maharashtra 411018
Pune
MAHARASHTRA 		 8902909231

sub_ghosh62@rediffmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:H108||Other conjunctivitis. Ayurveda Condition: VATAJA ABISHYANDAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-pariSheka, परिषेक (Procedure Reference: Sarangadhara Samhita (Uttara Khanda 13/6-7), Procedure details: 8 Parts milk,32 parts water taken together.it is boiled and reduced to the quality equivalent of milk.then 1 part of saindhava lavana is added.then this ksheer saindhav pariseka will be poured on closed eye slowly and steadily over kaninika end (inner canthus) from the height of 4 anguli for 600 matra kala(6 minute) duration.this procedure will be done once in daily for 5 days.)
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1) Patient suffering from symptoms of vataja Abhishyanda i.e irritation in eye, Foreign Body Sensation, Hyperemic conjunctiva, Swollen lids, and Watery discharge will be selected irrespective of their sex, education, socio economic status & religion
2) Between the age group of 18 to 60 yrs will be included in the study.
 
 
ExclusionCriteria 
Details  1)Patients with any other ocular pathology like Bacterial conjunctivitis, corneal opacity, corneal ulcer, Malignancy, Immunosuppressive disorder
2)Cases complicated with dacryocystitis
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To study the efficacy of Ksheer saindhava pariseka to reduce inflammation in vataja abhishyanda ( simple allergic conjunctivitis)  Daily treatment for 5 days and only follow up on 7th day 
 
Secondary Outcome  
Outcome  TimePoints 
study of properties of ksheer saindhava like vata hara, snigdha, chakshushya,Balya  Daily treatment for 5 days and only follow up on 7th day 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   17/02/2022 
Date of Study Completion (India) 12/12/2022 
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 Yet Recruiting 
Recruitment Status of Trial (India)  Completed 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   The aim of the study is to see the effectiveness of Ksheer Saindhava Pariseka in the management of vataja abhishyanda (Simple Allergic Conjunctivitis). The study will be conducted with 30 patients ,showing signs and symptoms of vataja abhishyanda.Ksheer Saindhava Pariseka will be given for this condition for  5 days daily  and only  follow up will be done on 7th day and final conclusion will be drawn on the basis of proper statistical methods. 
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