To study the effect of Ayurvedic formulations on PramehajanyaTimira/Diabetic Macular Edema.

A Randomized Clinical Trial to evaluate the efficacy of Khadirakramuka Kwath and Nishamlaki Per Orum with and without Nitya Virechana in the management of Pramehajanya Timira with special reference to Diabetic Macular Edema

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/06/043269

Enrollment

Registered

2022-06-15

Start date

Unknown

Completion date

Unknown

Last updated

2023-11-13

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

Conditions

Health Condition 1: E133- Other specified diabetes mellituswith ophthalmic complications

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients between 40-70 years of age. 2. Diagnosed cases of Diabetes Mellitus Type 2. 3. NPDR cases with Macular Edema. 4. Clinically significant Diabetic Macular Edema of less than 12 months duration. 5. Visual acuity minimum 6/60 or better. 6. Patients having HbA1c levels upto 8.

Exclusion criteria

Exclusion criteria: 1. Hypertensive patients with systolic BP >160 and diastolic BP >95 mm Hg. 2. Patients having HbA1c levels greater than 8. 3. Diabetic patients with cardiovascular problems. 4. History of ocular surgery within 4 months prior to enrolment. 5. Pregnant diabetic patients. 6. Patients with moderate to severe cataractous changes. 7. Patients having a history of glaucoma or on-going treatment of glaucoma.

Design outcomes

Primary

Measure	Time frame
Changes in Central macular thickness Optical Coherence Tomography (OCT) in patients of DME.Timepoint: At Baseline day and after completion of the trial	—

Secondary

Measure	Time frame
1. Changes in visual acuity in patients of DME. 2. Change in metamorphopsia (Amsler’s grid test findings) in patients of DME. 3. Change in colour vision in patients of DME. Timepoint: At Baseline day and after completion of the trial	—

Countries

India

Contacts

Public ContactDr Gulab Chand Pamnani

National Institute of Ayurveda, Jaipur

pamnani.gulab@gmail.com9461154942

Outcome results