Comparing Herbal treatments for diabetic eye complications

Comparative Clinical Study Of Madhumeha¯ri¯-Cu¯r?a With Or Without Triphala¯-Gh?ta Ak?itarpa?a In The Management Of Prameha Upadrava With Special Refrence To Non Proliferative Diabetic Retinopathy In The Purview Of Pra¯ya? Pradha¯napras ?ame Pras ?amo Bhavati - nil

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/05/066977

Enrollment

Registered

2024-05-08

Start date

Unknown

Completion date

Unknown

Last updated

2024-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

None listed

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Changes in Features of Non proliferative diabetic retinopathy in ETDRS Score.Timepoint: 45th day	—

Secondary

Measure	Time frame
Changes in the clinical symptoms of Non proliferative diabetic retinopathy.Timepoint: 45 Days	—

Countries

India

Contacts

Public ContactDr Mayank Kumar Gupta

National Institute of Ayurveda

abhijit.samhita@nia.edu.in9689237789

Outcome results