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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-70
SponsorFirst Affiliated Hospital of Zhejiang University

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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).

Trial design

Treatments tested in this trial

  • Conbercept Ophthalmic Injection
  • Tongluo Huayu Formula
  • Laser Photocoagulation

Treatment groups

80 Participants
are divided into 2 treatment groups

Sponsors and collaborators

First Affiliated Hospital of Zhejiang University

Lead sponsor

Zhejiang Provincial Tongde Hospital

Collaborator

The Fourth Affiliated Hospital of Zhejiang University School of Medicine

Collaborator