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CTRI Number  CTRI/2024/03/063439 [Registered on: 01/03/2024] Trial Registered Prospectively
Last Modified On: 29/02/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Use of Katakadirasanjana Eye Drop in Simple Allergic Conjuctivitis 
Scientific Title of Study   Clinical evaluation of Katakadi eye drop in simple allergic conjuctivitis 
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 Khem Chand Sharma 
Designation  Professor and Head 
Affiliation  Rishikul Ayurved Campus 
Address  PG Department of Rasa Shastra and Bhaishajya Kalpana Uttarakhand Ayurved University Rishikul Campus Haridwar
PG Department of Rasa Shastra and Bhaishajya Kalpana Uttarakhand Ayurved University Rishikul Campus Haridwar
Hardwar
UTTARANCHAL
249401
India 
Phone  8006945015  
Fax    
Email  drkhemchand.sharma@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Khem Chand Sharma 
Designation  Professor and Head 
Affiliation  Rishikul Ayurved Campus 
Address  PG Department of Rasa Shastra and Bhaishajya Kalpana Uttarakhand Ayurved University Rishikul Campus Haridwar
PG Department of Rasa Shastra and Bhaishajya Kalpana Uttarakhand Ayurved University Rishikul Campus Haridwar
Hardwar
UTTARANCHAL
249401
India 
Phone  8006945015  
Fax    
Email  drkhemchand.sharma@gmail.com  
 
Details of Contact Person
Public Query  
Name  GARGI VERMA 
Designation  PG Scholar 
Affiliation  Rishikul Ayurved Campus 
Address  PG Department of Rasa Shastra and Bhaishajya Kalpana Uttarakhand Ayurved University Rishikul Campus Haridwar
PG Department of Rasa Shastra and Bhaishajya Kalpana Uttarakhand Ayurved University Rishikul Campus Haridwar
Hardwar
UTTARANCHAL
249401
India 
Phone  7060562578  
Fax    
Email  svssssverma8@gmail.com  
 
Source of Monetary or Material Support  
Rishikul Campus Uttarakhand Ayurved University Haridwar 249401 
 
Primary Sponsor  
Name  Uttarakhand Ayurved University 
Address  Uttarakhand Ayurved University,Railway Road Harrawala Dehradun 
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 
Gargi Verma  Rishikul Campus Haridwar  OPD Number-5 & IPD of Shalakya Tantra Department Rishikul Campus Uttarakhand Ayurved University Uttarakhand Haridwar 249401
Hardwar
UTTARANCHAL 		 07060562578

svssssverma8@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee,Uttarakhand Ayurved University  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:H102||Other acute conjunctivitis. Ayurveda Condition: ABISHYANDAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-ropaNa-AScyotanam, रोपण- आश्च्योतनम् (Procedure Reference: Sharangdhar Samhita Uttarkhand 13/103, Procedure details: Ocular Application of Eye Drop 2 drops four times a day for 15 Days. )
(1) Medicine Name: Katakadirasanjana Eye Drop, Reference: Sharangdhar Samhita Uttarkhand 13/103, Route: Ocular, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 2(drops), Frequency: qid, Duration: 15 Days
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Age group of 16-60 yrs.
2.The patients have the signs and symptoms of simple allergic conjuctivitis like itching/redness/watering/chemosis.
3.either sex 
 
ExclusionCriteria 
Details  1.Patients not willing for Trial.
2.Patients suffering from Dry Eye/Blepharitis/Trichiasis/Dacrocystitis/Trachoma and Other acute and chronic diseases of eye.
3.Complicated Conjuctivitis and Conjuctival Diseases.
4.Known cases of other systematic disorders like Hypertension,Diabetes,Skin Allergy and Asthma. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Outcome will be assess on the basis of decrease in subjective parameters like 1.Redness
2.itching
3.watering
4.Chemosis
5.photophobia
6.burning sensation 		 The assessment will be done on 1st,7th and after completion of the trial i.e on 15th day 
 
Secondary Outcome  
Outcome  TimePoints 
Outcome will be assess on the basis of decrease in objective parameters like.
1.Palpebral Conjuctival Congestion
2.Bulbar Conjuctival Congestion
3.Absolute Eosinophils Count
4.Papillae on Palpebral aperature 		 The assessment will be done on 1st,7th and after completion of the trial i.e on 15th day 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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 1/ Phase 2 
Date of First Enrollment (India)   11/03/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  11/03/2024 
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   This Study is a single arm study to see the clinical effect of katakadirasanjana eye drop in simple allergic conjuctivitis.Katakadirasanjana consists like ingredients like Kataka,Madhu and Karpura.In this trial,patients with classical symptoms of conjuctivitis/abhishyanda will be selected from OPD and IPD of Shalakya Tantra Department of Rishikul Campus Haridwar Uttarakhand Ayurved University.In this study  30 patients will be selected and will be given Katakadirasanjana Eye Drop for local application for 15 days.Assessment will be done on the basis of various parameters before and after treatment is done. 
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