| CTRI Number |
CTRI/2026/02/104432 [Registered on: 20/02/2026] Trial Registered Prospectively |
| Last Modified On: |
19/02/2026 |
| 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
|
Comparing Ayurvedic Eye Drops and Eye Application in Conjunctivitis |
|
Scientific Title of Study
|
A RANDOMIZED COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFECT OF
PASHUPATA VARTI ANJANA AND PASHUPATA EYE DROPS IN ABHISHYANDA W.S.R. TO
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 Sumi S |
| Designation |
PG SCHOLAR |
| Affiliation |
Parul Institue of Ayurved and Research |
| Address |
Department of Shalakya Tantra
Parul institute of ayurved and research
Parul University.
P.O.Limda, Tal.Waghodia - 391760
Dist.Vadodara, Gujarat
Vadodara GUJARAT 391760 India |
| Phone |
6374725361 |
| Fax |
|
| Email |
drsumisinnapillai@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Ganesh Tejasvi S |
| Designation |
Associate Professor |
| Affiliation |
Parul Institue of Ayurved and Research |
| Address |
Department of Shalakya Tantra
Parul institute of ayurved and research
Parul University.
P.O.Limda, Tal.Waghodia - 391760
Dist.Vadodara, Gujarat
Vadodara GUJARAT 391760 India |
| Phone |
9164774710 |
| Fax |
|
| Email |
ganeshtejasvi@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Ganesh Tejasvi S |
| Designation |
Associate Professor |
| Affiliation |
Parul Institue of Ayurved and Research |
| Address |
Department of Shalakya Tantra
Parul institute of ayurved and research
Parul University.
P.O.Limda, Tal.Waghodia - 391760
Dist.Vadodara, Gujarat
Vadodara GUJARAT 391760 India |
| Phone |
9164774710 |
| Fax |
|
| Email |
ganeshtejasvi@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Sumi S |
| Address |
Department of Shalakya tantra, Parul Institute of Ayurved and Research, Parul University, Ishwarpura road, Limda, Vadodara, Gujarat - 391760, India. |
| Type of Sponsor |
Other [SELF] |
|
|
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 Sumi S |
KHEMDAS HOSPITAL |
OPD no.4, Eye OPD, Department of Shalakya Tantra, Ground floor, Parul Institute
of Ayurved and Research, Parul University, Vadodara - 391760, Gujarat, India.
Vadodara
GUJARAT Vadodara GUJARAT |
6374725361
drsumisinnapillai@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PIAR-IECHR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H10||Conjunctivitis. Ayurveda Condition: ABISHYANDAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | a~jjanam, अंजनम् | (Procedure Reference: Sushruta Samhita, Uttara Tantra, Procedure details: Collyrium applying the inner canthus of eyes and washing it with clean water after 10 minutes) (1) Medicine Name: Pashupata Varti, Reference: Ashtanga Hrudaya, Uttara Sthana, Chapter 16, sloka 25-27, Route: Topical, Dosage Form: Varti/ Suppository, Dose: 250(mg), Frequency: bd, Duration: 7 Days | | 2 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Pashupata Eye Drops, Reference: NA, Route: Topical, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 1(drops), Frequency: qid, Bhaishajya Kal: Muhurmuhu, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Participants between the age group of 18-60 years will be selected irrespective of gender.
2. Participants fulfilling one or more features of conjunctivitis. |
|
| ExclusionCriteria |
| Details |
1. Participants with keratoconjunctivitis, giant papillary conjunctivitis.
2. Known case of glaucoma.
3. Participants who have undergone eye surgery within last 6 months and suffering from corneal pathology, ocular injuries and suspected foreign body in the eye.
4. Participants taking anti allergic medication and also using any kind of eye drops.
5. Pregnant ladies and lactating mothers. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in the signs and symptoms of conjunctivitis assessed using a clinical grading score. |
Baseline, 7th day and 14th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Evaluation and comparison of the efficacy of Pashupata Varti Anjana and Pashupata Eye Drops. |
on 7th day and 14th day |
|
|
Target Sample Size
|
Total Sample Size="100" Sample Size from India="100"
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)
|
08/07/2026 |
| 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="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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [drsumisinnapillai@gmail.com].
- For how long will this data be available start date provided 22-07-2027 and end date provided 21-07-2028?
Response (Others) - oone year post publication of research paper
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This randomized comparative clinical trial is designed to evaluate and compare the safety and therapeutic efficacy of Pashupata Varti Anjana and Pashupata Eye Drops in the management of Abhishyanda, which is correlated with conjunctivitis in modern medicine. Abhishyanda is characterized by symptoms such as redness, itching, discharge, burning sensation, and irritation of the eyes. A total of 100 participants diagnosed with Abhishyanda will be randomly allocated into two groups. One group will receive Pashupata Varti Anjana, while the other group will receive Pashupata Eye Drops for a duration of 7 days. Clinical assessment will be done based on subjective symptoms and objective ophthalmological findings before and after treatment. The objective of the study is to scientifically evaluate and compare the effectiveness, safety, and patient acceptability of the traditional Anjana form and the modified eye drop form of Pashupata formulation. The study aims to provide clinical evidence for the use of Ayurvedic formulations as a safe and effective treatment option for conjunctivitis. |