Health Condition 1: null- Dry Eye Syndrome
Conditions
Sponsors
Department of AYUSH Ministry of Health Family Welfare Government of India
Eligibility
Inclusion criteria
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. 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 1. Change in the Tear Film break up time 2. Change in Schirmer I Test 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. | — |
Countries
India
Contacts
Public ContactDr Pradeep Dua
Central Council for Research in Ayurvedic Sciences (CCRAS)
Outcome results
None listed