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A clinical study to see the effect of an Ayurvedic formulations in the management of Conjunctivitis occruing due to allergy

Phase 2
Completed
Conditions
Health Condition 1: null- Allergic Conjunctivitis
Registration Number
CTRI/2018/07/014801
Lead Sponsor
Central Council for Research in Ayurvedic Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

1. Patients of either sex aged between 18-60 years

2. Patients presenting with signs and symptoms of Acute Allergic Conjunctivitis like Itching, Redness, Watering, Swelling and Foreign body sensation as assessed through Visual Analogue Scale (VAS) Scoring Method

3. Patients with presence of Papillae in conjunctiva on examination through Slit Lamp Examination (SLE) and/ or positive conjunctival smear test for Acute Allergic Conjunctivitis (presence of abundance of eosinophils).

4. Willing and able to participate for 2 weeks.

Exclusion Criteria

1.Patients having other form than SAC, PAC of Allergic Conjunctivitis - like Vernal Kerato-conjunctivitis, Atopic Kerato-

conjunctivitis, Giant Papillary Conjunctivitis, Phlyctenular conjunctivitis etc.

2.Patients having any other associated ocular pathology like marginal Corneal ulcer, Dacryocystitis, Trachoma, Kerato-Conjunctivitis,infective Conjunctivitis etc clinically.

3.Patients with concurrent serious hepatic disorder, renal disorder, Severe Pulmonary Dysfunction (uncontrolled Bronchial Asthma and

/ or Chronic Obstructive Pulmonary Disease (COPD) or uncontrolled metabolic diseases (Diabetes Mellitus, Hypertension etc) or any evidenceof malignancy.

4.Pregnant / lactating females.

5.Patients on steroids, oral contraceptives, or estrogen replacement

therapy.

6.Smokers/Alcoholics and/or drug abusers.

7.H/o Patients suffering from major systemic illness necessitating long term drug treatment (Rheumatoid arthritis, Psycho-Neuro- Endocrinal disorders, etc..

8.H/o hypersensitivity to the trial drug or any of its ingredients.

9.Patients who have completed participation in any other clinical trial during the past six months.

10.Any other condition which the Investigator

thinks may jeopardize the study.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
To assess the efficacy of AYUSH PE Eye Drops in Acute Allergic Conjunctivitis based on improvement in signs and symptoms by using Visual Analogue Scale (VAS) Scoring MethodTimepoint: At Baseline, seventh day and at the end of follow up after fourteenth day
Secondary Outcome Measures
NameTimeMethod
To assess the safety of AYUSH PE Eye Drops in Acute Allergic Conjunctivitis by means of External eye examination, Visual Acuity and FundoscopyTimepoint: At Baseline, seventh day and at the end of follow up after fourteenth day
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