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CTRI Number  CTRI/2025/08/093791 [Registered on: 27/08/2025] Trial Registered Prospectively
Last Modified On: 27/08/2025
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   A Study to Compare the Efficacy of Rasanjanadya Aschyotana and Olopatadine 0.1% eye drops in the Management of Kaphaja Abhishyanda (Simple Allergic Conjunctivitis) 
Scientific Title of Study   A Randomized Open Label Controlled Clinical Study to Compare the Efficacy of Rasanjanadya Aschyotana and Olopatadine 0.1% Eye Drops in the Management of Kaphaja Abhishyanda (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 Prerna 
Designation  MS Shalakya Tantra Scholar 
Affiliation  Institute for Ayurved Studies and Research SKAU Kurukshetra 
Address  Opd no 54 Ground floor Department of Shalakya Tantra Institute for Ayurved Studies and Research Shri Krishna AYUSH University Kurukshetra Haryana 136118 India

Kurukshetra
HARYANA
136118
India 
Phone  7015247038  
Fax    
Email  jangraprerna85@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ashu 
Designation  Chairperson, PG Department of Shalakya Tantra 
Affiliation  Institute for Ayurved Studies and Research SKAU Kurukshetra 
Address  Room no 108 1st floor Department of Shalakya Tantra Institute for Ayurved Studies and Research Shri Krishna AYUSH University Kurukshetra Haryana 136118 India

Kurukshetra
HARYANA
136118
India 
Phone  09416553131  
Fax    
Email  drashukataria@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Ashu 
Designation  Chairperson, PG Department of Shalakya Tantra 
Affiliation  Institute for Ayurved Studies and Research SKAU Kurukshetra 
Address  Room no 108 1st floor Department of Shalakya Tantra Institute for Ayurved Studies and Research Shri Krishna AYUSH University Kurukshetra Haryana 136118 India

Kurukshetra
HARYANA
136118
India 
Phone  09416553131  
Fax    
Email  drashukataria@gmail.com  
 
Source of Monetary or Material Support  
Institute for Ayurved Studies and Research Sector 8 Umri Road Kurukshetra Haryana India 136118 
 
Primary Sponsor  
Name  Institute for Ayurved Studies and Research 
Address  Sector 8 Umri Road Kurukshetra Haryana 136118  
Type of Sponsor  Other [Government Ayurvedic 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 
Dr Prerna  Institute for Ayurved Studies and Research Hospital  OPD No. 54 Shalakya Netra, Institute for Ayurved Studies and Research Hospital, sector 8 umri road kurukshetra 136118 Kurukshetra HARYANA
Kurukshetra
HARYANA 		 7015247038

jangraprerna85@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Shri Krishna Ayush University Kurukshetra  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: KAPABISHYANDAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-AScyotanam, आश्च्योतनम् (Procedure Reference: Gada Nigraha, Procedure details: 1.Form Eye drops with 1.Rasanjana 2.Haridra 3.Daruharidra 4.Gokshura 5.Shunthi 6.Madhu. Patients will be given an Aam Pachana drug Shunthi Churna as purva karma medicine for initial 5 days in dose 1.5 gm BD. After which Aschyotana will be done for 30 days. )
(1) Medicine Name: Rasanjanadya Aschyotana, Reference: Gada Nigraha Tritiya Khanda 3/125, Route: Ocular, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 2(drops), Frequency: qid, Duration: 30 Days
2Comparator Arm (Non Ayurveda)-Olopatadine 0.1% eye dropsOlopatadine 0.1% eye drops are Dual action antihistamine and mast cell stabilizer. •Dose - 1-1 drop twice a day. •Frequency - 2 times a day. •Duration -35 Days.
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Age- 16-60 years
2. Patients with sign and symptoms of Kaphaja Abhishyanda (Simple Allergic Conjunctivitis) will be selected irrespective of Sex, Religion and Profession.
3. Patients those are fit for Aschyotana Karma according to Ayurveda text23.
4. Patient willing to participate and able to provide signed informed consent.
 
 
ExclusionCriteria 
Details  1. Age group less than 16 years and more than 60 years.
2. The patient having any systemic illness, like - Diabetes mellitus, Hypertension, Tuberculosis, etc.
3. Patients suffering from other type of Conjunctivitis, Marginal Corneal Ulcer, Dacryocystitis and other ocular manifestations.
4. Patients with alcohol, opioids / drug addiction and using any other systemic drugs which may alter the result of study.
5. Patients having genetic predisposition to allergy.
6. Pregnant and lactating mothers.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1. Change in scoring pattern of sign and symptoms of Kaphaja Abhishyanda (Simple Allergic Conjunctivitis).   35th day 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="44"
Sample Size from India="44" 
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)   01/12/2025 
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="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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   Kaphaja Abhishayanda is characterized by Ushnaabhinanda (Want of warmth), Guruta (heaviness of lids), Akhshishopha (swelling of eyes), Kandu (itching), Updeha (stickiness in eyes), Atisitata (Excessive coldness), Sravamuhurpichila (recurrent excessive slimy discharge from eye); so, on the basis of signs and symptoms Kaphaja Abhishyanda can be correlated with Simple Allergic Conjunctivitis. Simple Allergic Conjunctivitis, is a type-1 immediate hypersensitivity reaction mediated by IgE and subsequent mast cell activation, following exposure of ocular surface to airborne allergens.Ayurveda offers an alternative and holistic approach to manage such conditions using herbal formulations that aim at correcting the doshic imbalance while providing symptomatic relief.
Rasanjanadya Aschyotana, an Ayurvedic eye drop formulation comprising ingredients like Rasanjana, Haridra, and Madhu is described in classical texts for Kaphaja Abhishyanda.This study is designed to evaluate and compare the therapeutic efficacy of Rasanjanadya Aschyotana with that of Olopatadine 0.1% eye drops (Dual action antihistamine and mast cell stabilizer) in patients suffering from Kaphaja Abhishyanda (Simple Allergic Conjunctivitis). By employing a randomized open-label controlled clinical trial design, this research aims to generate scientific evidence for the effectiveness of Rasanjanadya Aschyotana, potentially establishing it as a viable, natural alternative to modern pharmacotherapy.

  
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