Effect of ayurvedic treatment on diabetic retinopathy

Phase 2/3

Not yet recruiting

Conditions: Type 2 diabetes mellitus with ophthalmic complications. Ayurveda Condition: TIMIRAH,

Brief Summary: This study is planned to evaluate the add on effect of ayurvedic protocol on non proliferative Diabetic retinopathy when used in addition to standard of care. Diabetic retinopathy is one of the major neurovascular complications of diabetes and is a leadingcause of blindness in adults of the working-age group. Almostall patients with type 1 diabetes develop retinopathy in about 15 years. Inthose with Type 2 DM, the risk of Diabetic Retinopathy increases with theduration of diabetes, accompanying hypertension and smoking. Diabetics have a20-25 times greater risk of blindness as compared to the normal population. Ninety-three millionpeople are globally affected by diabetic retinopathy. Onviewing the above burden of DR in society an effective and comprehensiveapproach is necessary to address this global problem. Though modern medicinehas solutions in early NPDR and NPDR stages, like Photocoagulation,intra-vitreal steroids and Anti VEGF injections but these too have theirlimitations in some cases. Thus, in this study an attempt has been made toexplore the possibilities to prevent and check the progression ofnon-proliferative diabetic retinopathy with Ayurveda interventions along withcomprehensive medicine.

Strategiesaimed at therapeutic interventions in diabetic retinopathy were based on theunderstanding of etiological and pathological mechanisms behind its developmentand progression in both modern medicine and Ayurveda.

Recruitment & Eligibility

Inclusion Criteria

1Patients suffering from Type II DM having Mild to Moderate Non-Proliferative Diabetic Retinopathy 2Patients willing for Ayurveda treatment protocol.
3Patients having history of Diabetes mellitus more than 5 years.
4Patients of DR who have undergone modern medical management and Laser Photocoagulation therapy previously for the same but with persisting symptoms and/or signs will also be included in the study.
5Taking oral hypoglycemic drugs or insulin.

Exclusion Criteria

1History of glaucoma 2Patients with moderate to severe Cataractous changes.
3Patients having proliferative and advanced Diabetic Retinopathy changes.
4Patients with any other complications of Diabetes like nephropathy and neuropathy.
5Patient having systemic diseases like hypertension, thyroid etc.

Primary Outcome Measures

Name	Time	Method
1To assess the retino-protective activity of polyherbal compound in the selected in-vivo model in terms of its anti- angiogenic activity	80 days including 40 days follow up
2To evaluate the change in the retinal oedema & retinal haemorrhages in patients with Non-Proliferative Diabetic Retinopathy in terms of OCT and Fundus photographs.	80 days including 40 days follow up

Secondary Outcome Measures

Name	Time	Method
1.Change in number & size of hard & soft exudates in terms of Fundus photographs.	2.Change in the quality of ocular health of patients of NPDR in terms of EDTRS visual acuity.

Locations (2): All India institute of Ayurveda
🇮🇳
South, DELHI, India
All India institute of Medical sciences
🇮🇳
South, DELHI, India
All India institute of Ayurveda
🇮🇳South, DELHI, India
Akanksha Thakur
Principal investigator
08700794589
dr.akanksha.thakur@gmail.com