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
NCT07718503 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80
Last updated 2026-07-22
Summary
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.
Conditions
Interventions
- DRUG
-
Conbercept Ophthalmic Injection
Intravitreal injection of Conbercept will be administered once a month for 3 consecutive months.
- OTHER
-
Tongluo Huayu Formula
The Tongluo Huayu Formula will be administered for 1 month.
- PROCEDURE
-
Laser Photocoagulation
Laser photocoagulation will be administered if large areas of retinal non-perfusion or fundus neovascularization occur.
Sponsors & Collaborators
-
Zhejiang Provincial Tongde Hospital
collaborator OTHER -
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
collaborator OTHER -
First Affiliated Hospital of Zhejiang University
lead OTHER
Principal Investigators
-
Hongguang Cui · Zhejiang University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 40 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-06-30
- Primary Completion
- 2028-12-31
- Completion
- 2028-12-31
Countries
- China
Study Locations
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