Comparing Herbal treatments for diabetic eye complications

Phase 2

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

Registration Number: CTRI/2024/05/066977

Lead Sponsor: ational Institute of Ayurveda, Jaipur

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

Patients of either sex in the age group of above 35 years and below 70 years irrespective of sex, race, religion, and socio-economic status.

Patient suffering from Diabetic retinopathy with the clinical feature of Non proliferative diabetic retinopathy (Mild to moderate).

HbA1c Levels: Patients with a known diagnosis of Type II diabetes mellitus and HbA1C levels 6.5- 8 %

Visual Acuity: Visual acuity should range from 6/60 to 6/9.

Central Retinal Thickness (CRT) at OCT: Must be greater than 400 microns and less than 600 microns.

Ocular Condition: Clear ocular media and sufficient pupillary dilatation to enable fundus imaging.

Diabetic Macular Oedema (DME): Clinically significant DME with a duration of less than 12 months.

Exclusion Criteria

Patient received anti-VEGF treatment within the previous 12 months.

Patients with visual impairments like Macular degenerations, Retinitis Pigmentosa.

Patients with, Mature Cataract, post Cataract surgeries, Glaucoma etc.

Patient suffering systemic illness which may cause visual impairment.

Patients with known allergies to any components of the proposed treatment should be excluded.

Known Drug Interactions: Patients taking medications with known interactions with the proposed treatment should not be included.

Participation in Other Clinical Trials: Patients who are currently participating in other clinical trials should be excluded to avoid potential confounding factors.

Cognitive Impairment: Patients with severe cognitive impairments that hinder their ability to understand and follow the treatment plan should be excluded.