A clinical study to see the effect of an Ayurvedic formulation in the treatment of Dry Eyes

Phase 2

• Conditions: Health Condition 1: null- Dry Eye Syndrome

• Registration Number: CTRI/2012/05/002639
• 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: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 150

Inclusion Criteria

1. Patients of either sex aged between 35 to 70 years.

2. Patients presenting with signs and symptoms of Dry eye syndrome.

ï?? Schirmer-I test positive i.e. < 10 mm.

ï?? Tear film break-up time less than 10 seconds.

ï?? Rose Bengal staining showing devitalized epithelium of conjunctiva and mucus plaques on the cornea.

(If Any two of the above three criteria are present; the diagnosis of Dry Eye Syndrome is confirmed)

3. Willing and able to participate in the study for 16 weeks.

Exclusion Criteria

1. Severe cases of dry eye syndrome with complications like perforated corneal ulcer, Uveitis, Glaucoma.

2. Inflammatory conditions like acute conjunctivitis etc.

3. Systemic diseases causing Dry Eye Syndrome.

4. 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.

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

6. Women who are pregnant or lactating

7. Patients on steroids, oral contraceptive pills, estrogen replacement therapy or any other medication that may adversely affect the outcome of the study

8. Smokers/Alcoholics and/or drug abusers

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

10. Patients with evidence of malignancy

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

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

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

14. Any other condition which the Principal Investigator thinks may jeopardize the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Change in the Clinical Parameters.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
1. Change in the Tear Film break up time <br/ ><br>2. Change in Schirmer I Test <br/ ><br>3. Change in Rose Bengal Staining.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.