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CTRI Number  CTRI/2026/03/106415 [Registered on: 17/03/2026] Trial Registered Prospectively
Last Modified On: 17/03/2026
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 Comparing an Ayurvedic Eye Application (Rasanjanadi Bidalaka) and Olopatadine Eye Drops in the Treatment of Allergic Conjunctivitis. 
Scientific Title of Study   A Randomized Controlled Trial to study the efficacy of Rasanjanadi Bidalaka and Olopatadine eye drop in Vataja Abhishyanda with reference to 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 Kanchan Krishnath Devkate 
Designation  MS Scholar Shalakyatantra (Ayurveda) 
Affiliation  MAMs Sumatibhai Shah Ayurved Mahavidyalaya 
Address  OPD No 9, Department of Shalakyatantra, Sane Guruji Arogya Kendra, Malwadi Road, Hadapsar, Pune, Maharashtra

Pune
MAHARASHTRA
411028
India 
Phone  9511664002  
Fax    
Email  devkatekanchan123@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Shamli Shailendrakumar Pawase 
Designation  Associate Professor Shalakyatantra 
Affiliation  MAMs Sumatibhai Shah Ayurved Mahavidyalaya 
Address  OPD No 9, Department of Shalakyatantra, Sane Guruji Arogya Kendra, Malwadi Road, Hadapsar, Pune, Maharashtra

Pune
MAHARASHTRA
411028
India 
Phone  9028185356  
Fax    
Email  zinjad46@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Shamli Shailendrakumar Pawase 
Designation  Associate Professor Shalakyatantra 
Affiliation  MAMs Sumatibhai Shah Ayurved Mahavidyalaya 
Address  OPD No 9, Department of Shalakyatantra, Sane Guruji Arogya Kendra, Malwadi Road, Hadapsar, Pune, Maharashtra


MAHARASHTRA
411028
India 
Phone  9028185356  
Fax    
Email  zinjad46@gmail.com  
 
Source of Monetary or Material Support  
Department of Shalakyatantra, Sane Guruji Arogya Kendra, Malwadi Road, Hadapsar, Pune, Maharashtra 411028 
 
Primary Sponsor  
Name  Sane Guruji Arogya Kendra 
Address  OPD No 9, Department of Shalakyatantra, Sane Guruji Arogya Kendra, Malwadi Road, Hadapsar, Pune, Maharashtra 411028 
Type of Sponsor  Research institution and hospital 
 
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 Kanchan Krishnath Devkate  MAMs Sumatibhai Shah Ayurved Mahavidyalaya  OPD No 9, Department of Shalakyatantra, Sane Guruji Arogya Kendra, Malwadi Road, Hadapsar, Pune, Maharashtra 411028
Pune
MAHARASHTRA 
9511664002

devkatekanchan123@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
MAMs SSAM and Sane Guruji Arogya Kendra 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: ABISHYANDAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-biDAlaka:, बिडालक: (Procedure Reference: Sharangdhar Samhita, Procedure details: The patient will be instructed to close their eyelids, and the index finger of their left hand will be placed on the outer corner of the eyelid. Next, with the index finger of the other hand, the medication will be gently massaged over the taut eyelids, starting from the inner canthus and moving to the outer canthus, for 10-15 repetitions. The medication will be left in place for 10-15 minutes, ensuring it does not dry completely (the duration may vary depending on the season, with longer times in the rainy and winter seasons, and shorter times in the summer). If the patient experiences any adverse effects, such as hypersensitivity reactions, redness, or itching, appropriate treatment will be provided.)
(1) Medicine Name: Rasanjanadi Bidalak, Reference: Gada Nigraha, Route: Topical, Dosage Form: Churna/ Powder, Dose: 7(g), Frequency: od, Duration: 7 Days
2Comparator Arm (Non Ayurveda)-Olopatadine 0.2% Eye DropOlopatadine 0.2% Eye Drops, one drop in each eye twice a day for 7 days
 
Inclusion Criteria  
Age From  19.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  a. Individuals experiencing Vataja Abhishyanda, characterized by symptoms such as Toda (Pricking sensation), Sangharsha (Itching sensation), Shishirashruta (Cold lacrimation), and Alpa Shopha (Chemosis).
b. Age: 19-60 years
c. Irrespective of gender 
 
ExclusionCriteria 
Details  a. Any significant ocular infections, including corneal ulcers.
b. Pregnant and lactating women.
Acute keratoconjunctivitis, vernal keratoconjunctivitis, and giant
papillary conjunctivitis 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Symptoms like Toda (Pricking sensation),
Sangharsha (Foreign body sensation), Achchasruta (Watery discharge), Alpa Shopha (Chemosis), Vishushka Bhava (Feeling of dryness) wil be decreased.
 
Follow up on 3rd, 7th and 8th day 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="62"
Sample Size from India="62" 
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 3 
Date of First Enrollment (India)   15/04/2026 
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="15" 
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 aims to evaluate and compare the efficacy of Rasanjanadi Bidalaka, an Ayurvedic topical formulation, and Olopatadine eye drops, a commonly used modern anti-allergic medication, in the management of Vataja Abhishyanda with reference to allergic conjunctivitis. Allergic conjunctivitis is a prevalent ocular condition characterized by symptoms such as itching, redness, watering, foreign body sensation, and photophobia, which significantly affect patient comfort and quality of life. In Ayurvedic literature, Vataja Abhishyanda is described as an ocular disorder with clinical features that closely resemble allergic conjunctivitis, and it is managed through various local therapeutic measures including Bidalaka (application of medicated paste over the eyelids).

This randomized controlled trial is designed to assess the therapeutic effectiveness of Rasanjanadi Bidalaka in comparison with Olopatadine eye drops in reducing the clinical signs and symptoms associated with the condition. Eligible participants diagnosed with Vataja Abhishyanda/allergic conjunctivitis will be randomly allocated into two groups. One group will receive Rasanjanadi Bidalaka as a local Ayurvedic treatment, while the other group will be treated with Olopatadine eye drops as per standard ophthalmic practice. Clinical evaluation will be performed using predefined subjective and objective parameters such as itching, redness, watering, burning sensation, and conjunctival congestion. The changes in symptom severity before and after treatment will be assessed using appropriate scoring systems and statistical analysis to determine the significance of therapeutic outcomes.

The study seeks to explore the potential of a classical Ayurvedic external therapy as an effective and safe alternative or complementary approach in the management of allergic conjunctivitis. By comparing the outcomes with a widely accepted modern pharmacological agent, the trial aims to generate evidence regarding the clinical utility of Rasanjanadi Bidalaka and contribute to the integration of traditional Ayurvedic practices with contemporary ophthalmic care. The findings of this research may help in establishing an economical and accessible treatment option for patients suffering from allergic conjunctivitis while also validating Ayurvedic concepts in the management of ocular disorders

 
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