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Effect of ayurvedic treatment on diabetic retinopathy

Phase 2
Conditions
Health Condition 1: E113- Type 2 diabetes mellitus with ophthalmic complications
Registration Number
CTRI/2023/08/056373
Lead Sponsor
All India Institute of Ayurveda
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Yet Recruiting
Sex
Not specified
Target Recruitment
0
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.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
1To assess the retino-protective activity of polyherbal compound in the selected in-vivo model in terms of its anti- angiogenic activity <br/ ><br>2To evaluate the change in the retinal oedema & retinal haemorrhages in patients with Non-Proliferative Diabetic Retinopathy in terms of OCT and Fundus photographs.Timepoint: 80 days including 40 days follow up
Secondary Outcome Measures
NameTimeMethod
1.Change in number & size of hard & soft exudates in terms of Fundus photographs. <br/ ><br>2.Change in the quality of ocular health of patients of NPDR in terms of EDTRS visual acuity. <br/ ><br>Timepoint: 80 days including 40 days follow up
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