A clinical study to see the effect of an Ayurvedic formulation in the treatment of Conjunctivitis.

Phase 2

Completed

• Conditions: Health Condition 1: null- Allergic Conjunctivitis

• Registration Number: CTRI/2012/01/002375
• Lead Sponsor: Department of AYUSH Ministry of Health Family Welfare Government of India

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 150

Inclusion Criteria

1. Patients of either sex aged between 16-35years.

2. Patients presenting with signs and symptoms of Allergic Conjunctivitis.

3. Willing and able to participate for 16 weeks.

Exclusion Criteria

1. Patients having complications like marginal corneal ulcer, dacryocystitis, trachoma, kerato - conjunctivitis, Infective conjunctivitis, etc.

2. Patients having genetic predisposition to allergy.

3. Patients with concurrent serious Hepatic Dysfunction (defined as AST and/or ALT > 2 times of the upper normal limit) or Renal Dysfunction (defined as S. creatinine > 1.2mg/dl), uncontrolled Pulmonary Dysfunction (asthmatic and COPD patients) or other concurrent severe disease.

4. Patients with poorly controlled Diabetes Mellitus (HbA1c > 10%)

5. Patients with poorly controlled Hypertension ( > 160 / 100 mm Hg)

6. Pregnant / lactating females

7. Patients on steroids, oral contraceptive pills or estrogen replacement therapy.

8. Smokers/Alcoholics and/or drug abusers

9. Patients with evidence of malignancy

10. Patients suffering from major systemic illness necessitating long term drug treatment (Rheumatoid arthritis, Psycho-Neuro- Endocrinal disorders, etc.)

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

12. Patients who have completed participation in any other clinical trial during the past six (06) months.

13. Any other condition which the P.I. thinks may jeopardize the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ï?? Symptomatic improvement.Timepoint: At Baseline, 14th day-28th day-42nd day-56th day-70th day-84th day and at the end of follow up after 16th week.

Secondary Outcome Measures

Name	Time	Method
ILTimepoint: NI