Health Condition 1: null- Allergic Conjunctivitis
Conditions
Interventions
Intervention1: AYUSHPE eye drops (Coded drug): Two drops 6 times a day (four hourly) topically in each eye for 7 days
Control Intervention1: NIL: NIL
Sponsors
Central Council for Research in Ayurvedic Sciences
Eligibility
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
India
Contacts
Public ContactDr A K Srivastava
Regional Ayurveda Research Institute for Eye Diseases/CCRAS
Outcome results
None listed