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CTRI Number  CTRI/2025/01/079200 [Registered on: 22/01/2025] Trial Registered Prospectively
Last Modified On: 21/01/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To check efficacy of Shunthi Bidalak in redness of eyes . 
Scientific Title of Study   A Randomized Controlled Clinical study of Shunthi Bidalak in Simple 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 Mayur Nakade 
Designation  PG Scholar 
Affiliation  Bharati Vidyapeeth (Deemed To be University ) , College of Ayurveda, Pune-43 
Address  Bharati Vidyapeeth (Deemed To be University ) , College of Ayurveda, Department of Shalakyatantra , opd no . 26 ,Pune-43

Pune
MAHARASHTRA
411043
India 
Phone  9850670045  
Fax    
Email  mayur.nakade-ayurved@bvp.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Gajanan Patil 
Designation  Associate Professor 
Affiliation  Bharati Vidyapeeth (Deemed To be University ) , College of Ayurveda, Pune-43 
Address  Bharati Vidyapeeth (Deemed To be University ) , College of Ayurveda, Department of Shalakyatantra , opd no. 26 ,Pune-43

Pune
MAHARASHTRA
411043
India 
Phone  9923037117  
Fax    
Email  patil.gajanan1@bharatividyapeeth.edu  
 
Details of Contact Person
Public Query  
Name  Dr Gajanan Patil 
Designation  Associate Professor 
Affiliation  Bharati Vidyapeeth (Deemed To be University ) , College of Ayurveda, Pune-43 
Address  Bharati Vidyapeeth (Deemed To be University ) , College of Ayurveda, Department of Shalakytantra, opd no 26, Pune-43

Pune
MAHARASHTRA
411043
India 
Phone  9923037117  
Fax    
Email  patil.gajanan1@bharatividyapeeth.edu  
 
Source of Monetary or Material Support  
Bharati Vidyapeeth ( Deemed to be University ) , College of Ayurveda and Hospital, Department of Shalakyatantra , OPD no 26 
 
Primary Sponsor  
Name  Dr Mayur Nakade 
Address  Bharati Vidyapeeth ( Deemed to be university ) , College of Ayurved and Hospital, Opd No 24, Department of Shalakyatantra,Pune 43 Department of Shalakyatantra 
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 
Dr Mayur Nakade  College of Ayurved & Hospital , Pune , 411043  Department of ShalakyaTantra Opd No 26 Katraj , Pune , 411043
Pune
MAHARASHTRA 		 9850670045

mayur.nakade-ayurved@bvp.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ETHICS COMMITTEE [BV(DU)COA-EC]  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: ABISHYANDAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Shunthi Churna, Reference: Yog ratnakar, Route: Ocular, Dosage Form: Churna/ Powder, Dose: 100(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: -
2Comparator Arm (Non Ayurveda)-OlapatadineOlopatadine ophthalmic (eye) drops is used to treat itching of the eye caused by a condition known as allergic conjunctivitis (pink eye). This medicine is also used to treat eye itching or redness caused by pollen, ragweed, grass, animal hair, or dander.
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Participants suffering from Simple Allergic Conjunctivitis.
1 Age 18 to 60 years
2 Gender Both male and female 
 
ExclusionCriteria 
Details  1 Participants suffering from ocular surface pathology.
2 post-operative participants.
3 Participants suffering from all other type of conjunctivitis. 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Reduction of Itching.
Reduction of Burning sensation.
Reduction of Redness.
Reduction of Photophobia.
Reduction of Lacrimation. 		 14 days 
 
Secondary Outcome  
Outcome  TimePoints 
Relief From Signs And Symptoms   1 year 
 
Target Sample Size   Total Sample Size="56"
Sample Size from India="56" 
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)   01/02/2025 
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="0"
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 randomized controlled , open label , parallel group study on efficacy of Shunthi Bidalak in
Simple Allergic Conjunctivitis for 14 days in 30 patients with simple allergic conjunctivitis that will be conducted in Bharati Vidyapeeth (Deemed to be University), College of Ayurved and Hospital, Department of Shalakya Tantra, OPD number 24, Katraj, Dhankawadi, Pune
411043. The primary outcome measures will be Reduction of Itching,Burning sensation,Redness,Photophobia and Lacrimation.
 
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