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

No results posted yet for this study

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07718503 on ClinicalTrials.gov