A Study on the Combination of Tongluo Huayu Formula in Treating RVO of Phlegm-Stasis Intertwinement Type: Based on the Mechanism of Systemic Metabolic Regulation Mediated by Gut Microbiota

Starting soon · Not applicable

Conditions studied: Retinal Vein Occlusion

In brief

The goal of this clinical trial is to evaluate the synergistic efficacy and safety of the Tongluo Huayu Formula combined with conventional Western medical treatment for RVO, thereby providing high-quality evidence to support its subsequent clinical promotion and application. The control group will receive conventional Western medical therapy, including laser photocoagulation and intravitreal Conbercept injection. Specifically, Conbercept will be injected intravitreally once a month for 3 consecutive months. If large areas of retinal non-perfusion or fundus neovascularization occur during the study period, laser photocoagulation will be administered based on the patient's condition. The experimental group will receive the Tongluo Huayu Formula in addition to the standard therapy provided to the control group. The Tongluo Huayu Formula will be administered for 1 month. Relevant examinations and assessments for participants in both groups will be conducted at baseline (before treatment), and at 1, 2, 3, and 6 months after treatment.

Key facts

Study ID

NCT07718503

Run by

First Affiliated Hospital of Zhejiang University

People needed

80

Starts

2026-06-01

Expected to finish

2028-12-31

Last updated by the study team

2026-07-22

Who can join

Age: 40 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients who meet the aforementioned Western diagnostic criteria and TCM syndrome differentiation criteria for RVO, and are complicated with macular edema.
• Patients who fully understand the study and voluntarily sign the informed consent form.

You may not qualify if…

• Patients currently participating in other clinical trials or receiving concomitant use of similar traditional Chinese medicines or other therapies.
• Patients with other fundus retinal diseases, such as neovascular glaucoma or iris neovascularization.
• Patients with severe systemic diseases, such as rheumatism or systemic lupus erythematosus.
• Women who are pregnant or breastfeeding (lactating).
• Patients with severe cardiovascular or cerebrovascular diseases, or those with severely impaired hepatic or renal function.

Where it is running

• The First Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou, Zhejiang, China

Full record on ClinicalTrials.gov

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