The efficacy and safety of adjuvant supplementation with green tea extract on diabetic macular edema, a double blind randomized clinical trial

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20110811007297N9

Enrollment

Registered

2024-06-21

Start date

2024-06-21

Completion date

Unknown

Last updated

2024-06-24

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

Conditions

Diabetic macular edema. Type 2 diabetes mellitus with unspecified diabetic retinopathy with macular edema

Interventions

Intervention 1: Intervention group: In the intervention group, people receive a daily pill that contains 450 mg of green tea extract (GTE) supplement for 24 weeks. Intervention 2: Control group: In t

Eligibility

Sex/Gender

All

Age

30 Years to 65 Years

Inclusion criteria

Inclusion criteria: Patients with type 2 diabetes Age between 30 and 65 years Patients diagnosed with Diabetic Macular Edema (DME) Receive standard treatment with anti-vascular endothelial growth factor (VEGF) therapy with corticosteroids Central macular thickness (CMT) greater than 350 µm, as measured by spectral domain optical coherence tomography (SD-OCT) Willing and capable of providing written informed consent

Exclusion criteria

Exclusion criteria: Patients with monocular Patients with Glaucoma Epiretinal or vitreomacular membrane tension in fundus examination or OCT Significant cataract or posterior capsular opacity affecting visual acuity Vitreous hemorrhage that prevents the posterior view of the fundus Previous history of vitrectomy surgery Previous history of cataract surgery in the last three months High myopia (refractive errors greater than -6 diopters) Systemic or intravitreal injection of immunosuppressive drugs and corticosteroids Liver or kidney failure Pregnant or lactating women Known sensitivity or intolerance to green tea extract (GTE) or any of the excipients in GTE tablets Currently taking any medication or herbal supplement that may interfere with the study intervention Inability or unwillingness to comply with study procedures and follow-up program Dens vitreous hemorrhage

Design outcomes

Primary

Measure	Time frame
The severity of diabetic macular edema in oct. Timepoint: Preparation of oct before the intervention and after the end of the intervention. Method of measurement: Macular oct.	—

Secondary

Measure	Time frame
Primary Visual acuity. Timepoint: Before and after intervention. Method of measurement: E chart.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohmmad Karim Johari

Shiraz University of Medical Sciences

mkjoharii@gmail.com+98 71 3629 1779

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026