Role of Rasanjanadi Anjana inSeasonal Allergic Conjunctivitis

Phase 2

Conditions: Health Condition 1: H101- Acute atopic conjunctivitis

Registration Number: CTRI/2024/03/064625

Lead Sponsor: Dr Palash Agrawal

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

Patients who will meet the following criteria will be selected for the study.

a) Patients of either gender aged 12 years or older and suffering from SAC, will be diagnosed on the basis of their history, the presence of moderate to severe ocular itching, and at least one of the following bilateral signs and symptoms of at least moderate severity: conjunctival hyperaemia, conjunctival chemosis, eyelid swelling, or tearing.

b) Patients able to maintain a diary.

c) Patients able and willing to provide written informed consent.

d) No expectation that subject will be moving out of the area of the study center during the study period.

Exclusion Criteria

a) Patients with any other form of allergic conjunctivitis.

b) Patients with bacterial, chlamydial, viral, giant papillary, phlyctenular, purulent, and membranous conjunctivitis.

c) The presence of dry eye syndrome, blepharitis, uveitis, keratitis, and ocular trauma.

d) Patients with a history of ocular surgery performed in the last 3 months.

e) Patients who had systemic or ocular corticosteroids in the last 3 months, mast cell stabilizers within 2 weeks of randomization, or any other ophthalmic medication within 3 days of randomization.

f) Patients with retinal detachment, diabetic retinopathy, and progressive retinal disease.

g) Pregnant and lactating women.

h) Patients with a history of hypersensitivity to any of the study medications.

i) Active participation in any type of intervention study.

j) Patients who start developing complications.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean change in responder rate as judged by subjects about the overall effect of treatment on symptoms using a five-point grading scale at the follow-up and end visit compared with baseline.Timepoint: day 7, day 15, day 21, day 30, and day 45.

Secondary Outcome Measures

Name	Time	Method
1. Mean change in investigator assessment score (overall effect of treatment on signs & symptoms) at the follow-up & end visit compared with baseline. <br/ ><br>2. Mean change in the severity of individual & composite scores of ocular symptoms (itching, tearing) & signs (redness, eyelid swelling, chemosis, papillae) after 4 weeks of treatment compared with baseline. <br/ ><br>3. The tolerability & safety of Ayurvedic intervention (Rasanjanadi Anjana).Timepoint: day 7, day 15, day 21, day 30, & day 45.