A Clinical Study to Compare Two Ayurvedic Medicines, Given With and Without a Mild Daily Cleansing Therapy, to See How Well They Improve Vision Problems Caused by Diabetes, Especially Swelling in the Retina of the Eye (Diabetic Macular Edema)

A RANDOMIZED COMPARATIVE CLINICAL TRIAL TO EVALUATE THE EFFICACY OF TRIPHALA KWATHA AND TRIPHALA GHAN VATI WITH AND WITHOUT NITYA VIRECHAN IN THE MANAGEMENT OF PRAMEHAJANYA TIMIRA W.S.R. TO DIABETIC MACULAR EDEMA. - NIL

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/12/099958

Enrollment

Registered

2025-12-29

Start date

Unknown

Completion date

Unknown

Last updated

2026-01-12

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

Conditions

Health Condition 1: H36- Retinal disorders in diseases classified elsewhere

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: Patients aged between 35 and 70 years Central retinal thickness on OCT more than 300 microns and less than 600 microns Diagnosed cases of Type 2 Diabetes Mellitus with HbA1c less than 8 percent Clinically significant diabetic macular edema of less than 12 months duration Clear ocular media with adequate pupillary dilatation permitting proper fundus imaging Best corrected visual acuity between 6/60 and 6/9

Exclusion criteria

Exclusion criteria: Hypertensive patients with systolic blood pressure more than 160 mm Hg and diastolic blood pressure more than 100 mm Hg Diabetic patients with a history of cardiovascular diseases such as coronary artery disease, post-myocardial infarction, or post-coronary artery bypass graft History of anti-vascular endothelial growth factor treatment within two months prior to enrollment History of pan-retinal photocoagulation within four months prior to enrollment History of any ocular surgery within four months prior to enrollment Presence or history of retinal or ocular pathologies other than diabetic macular edema, including any active ocular infection such as conjunctivitis, keratitis, scleritis, uveitis, or endophthalmitis, uncontrolled glaucoma, or mature cataract in either eye History of rhegmatogenous retinal detachment or macular hole stage 3 or stage 4 History of intraocular surgery including cataract surgery within sixty days prior to baseline Presence of any systemic disease or ongoing treatment that may progress, recur, or change during the study period and potentially bias the assessment of clinical outcomes Current or planned use of systemic medications known to be toxic to the lens, retina, or optic nerve Significant renal disease defined as chronic renal failure requiring dialysis or kidney transplantation

Design outcomes

Primary

Measure	Time frame
Changes in Central Retinal Thickness (OCT)Timepoint: 30 days	—

Secondary

Measure	Time frame
Changes in Visual acuity Change in Metamorphopsia (Amsler s grid test findings) Change in Color vision.Timepoint: 30 days	—

Countries

India

Contacts

Public ContactDr Ishu Parmar

National institute of ayurveda Jaipur Rajasthan

vaidya.rajsoni@gmail.com7017970757

Outcome results