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Clinical Trials/CTRI/2025/07/089925
CTRI/2025/07/089925
Not yet recruiting
Phase 2/3

A randomised controlled trial to study the efficacy of Ardhodaka Godugdha Aschyotana and Olopatadine 0.1 Percent eye drop in vataja netra abhishyanda (allergic conjunctivitis)

Tilak Ayurved Mahavidyalaya Pune1 site in 1 country60 target enrollmentStarted: July 30, 2025Last updated:

Overview

Phase
Phase 2/3
Status
Not yet recruiting
Sponsor
Tilak Ayurved Mahavidyalaya Pune
Enrollment
60
Locations
1
Primary Endpoint
decrease in pricking pain , congestion and oedema

Overview

Brief Summary

The study will be intervened by the treatment of Ardhodaka Godugdha Aschyotana and Olopatadine 0.1% Eye Drop to group A and group B respectively. The efficacy of the therapy will be assessed on the basis of subjective and objective criteria for statistical analysis. Scoring will be designed according to the severity of symptoms. The subjective and objective gradation of symptoms will be done as follows and the intensity of each symptom will be calculated before treatment, after treatment and after follow up. The effect of treatment result will be assessed in regards to clinical signs and symptoms on the basis of grading and scoring system. The signs and symptoms will be assessed by adopting the suitable scoring method.

Study Design

Study Type
Interventional
Allocation
Coin toss, Lottery, toss of dice, shuffling cards etc
Masking
None

Eligibility Criteria

Ages
18.00 Year(s) to 70.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Participants having any three of the above symptoms mentioned in subjective criteria of vataja netrabhishyanda ( allergic conjunctivitis).
  • Participant having age group of 18-70 years irrespective of their gender, caste, economic status & residence status.

Exclusion Criteria

  • 1.Patient with known case of corneal oedema, central corneal ulceration.other ocular pathology (e.g. infective conjunctivtis).
  • 2.Participant with known allergic reaction to sulphur drug or under medication for allergic disorders.

Outcomes

Primary Outcomes

decrease in pricking pain , congestion and oedema

Time Frame: 3 day

Secondary Outcomes

  • decrease in itching , Eye Discharge , Stiffness of lids(7 day)

Investigators

Sponsor
Tilak Ayurved Mahavidyalaya Pune
Sponsor Class
Private medical college
Responsible Party
Principal Investigator
Principal Investigator

Dr Neha Shailesh Agrawal

Tilak Ayurved Mahavidyalaya Pune

Study Sites (1)

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