Health Condition 1: E113- Type 2 diabetes mellitus with ophthalmic complications
Conditions
Interventions
Intervention1: Punarnavadi Kwath
Triphla Guggulu
Chandanadi Seka: 15 patients will be administered Punarnavadi Kwath 30 ml with Anupana of Gomutra, Triphla Guggulu 1gm thrice a day orally and Chandana
Sponsors
National Institute of Ayurveda
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age between 35-70years. 2. Central retinal thickness (CRT) at OCT > 300 microns to 3. Diagnosis of Type 2 Diabetes Mellitus with HbA1C 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in Central retinal thickness (OCT)Timepoint: 31 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in visual acuity Change in metamorphopsia (Amslerâ??s grid test findings) Change in color vision. Timepoint: 31 days | — |
Countries
India
Contacts
Public ContactDr Garima Gupta
National Institute of Ayurveda Jaipur Rajasthan
Outcome results
None listed