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CTRI Number  CTRI/2024/07/070915 [Registered on: 19/07/2024] Trial Registered Prospectively
Last Modified On: 19/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   A Comparative Clinical Study Of Punarnavadi Arka Eye Drops With Punarnava Arka Eye Drops In Allergic Conjunctivitis 
Scientific Title of Study   Randomised Comparative Clinical Study To Evaluate The Efficacy Of Punarnavadi Arka Aschyotana With Daruharidra Kwatha Seka And Punarnava Arka Aschyotana With Daruharidra Kwatha Seka In Kaphaja Abhishyanda Wsr Allergic Conjunctivitis 
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 Suchetha Jayaram 
Designation  Post Graduate Scholar 
Affiliation  Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital And Reseach Centre 
Address  Room no 21 Dept Of PG Studies In Shalakya Tantra Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital And Reseach Centre Vijayanagar Bangalore 560104
Dept Of PG Studies In Shalakya Tantra Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital And Reseach Centre Vijayanagar Bangalore 560104
Bangalore
KARNATAKA
560104
India 
Phone  973977120  
Fax    
Email  suchetha.jayaram@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Veena Shekar 
Designation  Professor 
Affiliation  Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital And Reseach Centre 
Address  Room no 21 Dept Of PG Studies In Shalakya Tantra Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital And Reseach Centre Vijayanagar Bangalore 560104
Dept Of PG Studies In Shalakya Tantra Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital And Reseach Centre Vijayanagar Bangalore 560104
Bangalore
KARNATAKA
560104
India 
Phone  9242314631  
Fax    
Email  ven280005@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Veena Shekar 
Designation  Professor 
Affiliation  Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital And Reseach Centre 
Address  Room no 21 Dept Of PG Studies In Shalakya Tantra Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital And Reseach Centre Vijayanagar Bangalore 560104
Dept Of PG Studies In Shalakya Tantra Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital And Reseach Centre Vijayanagar Bangalore 560104
Bangalore
KARNATAKA
560104
India 
Phone  9242314631  
Fax    
Email  ven280005@gmail.com  
 
Source of Monetary or Material Support  
Dr Suchetha Jayaram Room no 21 Dept Of PG Studies In Shalakya Tantra Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital And Reseach Centre Vijayanagar Bangalore karnataka India 560104 
 
Primary Sponsor  
Name  Dr Suchetha Jayaram  
Address  Room no 21 Dept Of PG Studies In Shalakya Tantra Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital And Reseach Centre Vijayanagar Bangalore Karnataka India 560104 
Type of Sponsor  Other [] 
 
Details of Secondary Sponsor  
Name  Address 
nil  not applicable 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Kiran M Goud  Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital And Research Centre   Room no 21 Dept Of PG Studies In Shalakya Tantra Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital And Reseach Centre Vijayanagar Bangalore Karnataka India 560104
Bangalore
KARNATAKA 		 9845109556

kiranmgoud@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
skamchrc  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:H109||Unspecified conjunctivitis. Ayurveda Condition: ABISHYANDAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-AScyotanam, आश्च्योतनम् (Procedure Reference: sushrutha samhita, Procedure details: Subjects will be instructed to instill Punarnava arka 8 drops in 4 divided doses into the conjunctival sac from a height of 2 Angula approximate 2inch 4 times a day in group B )
(1) Medicine Name: daruharidra, Reference: astanga hridaya, Route: Topical, Dosage Form: Kwatha/Kashaya, Dose: 500(ml), Frequency: od, Duration: 7 Days
(2) Medicine Name: punarnava , Reference: arka prakash, Route: Topical, Dosage Form: Arka, Dose: 8(drops), Frequency: qid, Duration: 14 Days
2Intervention ArmProcedure-AScyotanam, आश्च्योतनम् (Procedure Reference: sushruth samhitha, Procedure details: Subjects will be instructed to instill Punarnavadi arka 8 drops in 4 divided doses into the conjunctival sac from a height of 2 Angula approximate 2 inch 4 times a day in group A )
(1) Medicine Name: daruharidra, Reference: astanga hridaya, Route: Topical, Dosage Form: Kwatha/Kashaya, Dose: 500(ml), Frequency: od, Duration: 7 Days
(2) Medicine Name: punarnavadi, Reference: arka prakasha, Route: Topical, Dosage Form: Arka, Dose: 8(drops), Frequency: qid, Duration: 14 Days
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Subjects presenting with lakshanas of kaphaja abhisyanda
Subjects presenting with clinical features of allergic conjunctivitis
Subjects within the age group of 20 to 60 years irrespective of gender
 
 
ExclusionCriteria 
Details  Subjects with history of phlyctenular conjunctivitis Giant papillary conjunctivitis Contact dermatoconjunctivitis and toxic conjunctivitis
Subjects with history of allergic conjunctivitis associated with dacryocystitis and other ocular diseases and conjunctivitis complicated with corneal ulcers
Subjects with history of allergic conjunctivitis due to systemic and autoimmune diseases
Subjects with history of systemic diseases that interfere with the course of study
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To see the rate of healing of ulcer redness lalasrava ruja burning sensation by giving Triphala Kashaya kavalagraha and Pippalyadi Kashaya in the management of mukhapaka wsr Aphthous ulcer  total duration of study is 21 days seka and eye drops will be given for 7 days eye drops will be continued for next 7 days followup after 1 week 
 
Secondary Outcome  
Outcome  TimePoints 
nill  not applicable 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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 
Date of First Enrollment (India)   02/01/2025 
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   Years="1"
Months="6"
Days="5" 
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  

Hence the present study will be undertaken to evaluate and compare the efficacy of Punarnavadi arka aschyotana and Punarnava arka aschyotana along with Daruharidra kwatha seka in kaphaja abhishyanda wsr to allergic conjunctivitis

 
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