Role of ayurvedic therapeutics in the management of Diabetic macular edema (DME).

Phase 2

• Conditions: Health Condition 1: E113- Type 2 diabetes mellitus with ophthalmic complications

• Registration Number: CTRI/2021/05/033428
• Lead Sponsor: ational Institute of Ayurveda

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: 0

Inclusion Criteria

1. Age between 35-70years.

2. Central retinal thickness (CRT) at OCT > 300 microns to <600 microns.

3. Diagnosis of Type 2 Diabetes Mellitus with HbA1C < 8.

4. Clinically significant Diabetic Macular Edema of less than 12 months duration.

5. Clear ocular media and adequate pupillary dilatation to allow fundus imaging.

6. Visual acuity 6/60 to 6/9.

Exclusion Criteria

1. Hypertensive patients with systolic BP >160 and diastolic BP >90 mm Hg.

2. Diabetic patients with other cardiovascular problems like Coronary Artery Disease, Post Myocardial Infarction, Post Coronary Artery Bypass Graft cases.

3. Anti-vascular endothelial growth factor treatment (Anti-VGEF) within 2 months, prior to enrollment.

4. History of Pan Retinal Photocoagulation within 4 months prior to enrollment.

5. History of ocular surgery within 4 months prior to enrollment.

6. History of Retinal and ocular pathologies other than DME i.e. any active infection (e.g. Conjunctivitis, keratitis, scleritis, uveitis, endophthalmitis), uncontrolled Glaucoma, mature cataract in either one or both eyes.

7. Pregnant diabetic patients.

8. History of rhegmatogenous retinal detachment or macular hole (stage 3 or 4).

9. Intraocular surgery (including cataract surgery) within 60 days preceding baseline.

10. Any type of systemic disease or its treatment, including any medical condition (controlled or uncontrolled) that could be expected to progress, recur, or change to such an extent that it may bias the assessment of the clinical status of the patient to a significant degree.

11. Subjects with current or planned use of systemic medications known to be toxic to the lens, retina or optic nerve.

12. Significant renal disease, defined as a history of chronic renal failure requiring dialysis or kidney transplant.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in Central retinal thickness (OCT)Timepoint: 31 days

Secondary Outcome Measures

Name	Time	Method
Changes in visual acuity <br/ ><br>Change in metamorphopsia (Amslerâ??s grid test findings) <br/ ><br>Change in color vision. <br/ ><br>Timepoint: 31 days