| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H108||Other conjunctivitis. Ayurveda Condition: ABISHYANDAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | 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 | | 2 | Comparator Arm (Non Ayurveda) | | - | Olopatadine 0.2% Eye Drop | Olopatadine 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 |