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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Retinal Vein Occlusion
• Intervention / Treatment: Drug: Conbercept Ophthalmic Injection; Other: Tongluo Huayu Formula; Procedure: Laser Photocoagulation

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Wei Zhou; Phone Number: 18101092595; Email: 15575924800@163.com

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310003
      • The first Affiliated Hospital, Zhejiang University School of Medicine
      • Contact: Wei Zhou; Phone Number: 18101092595; Email: 15575924800@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Group; Combined TCM and Western Medicine	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.
Active Comparator: Control Group; Conventional Western Medicine Only	Drug: Conbercept Ophthalmic Injection; Intravitreal injection of Conbercept will be administered once a month for 3 consecutive months.; Procedure: Laser Photocoagulation; Laser photocoagulation will be administered if large areas of retinal non-perfusion or fundus neovascularization occur.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Central Macular Thickness（CMT）	Central Macular Thickness (CMT) measured by Optical Coherence Tomography Angiography (OCTA) in micrometers (μm).	Baseline, and at 1, 2, 3, and 6 months after treatment.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Best Corrected Visual Acuity(BCVA)	Best Corrected Visual Acuity (BCVA) assessed using the standard logarithmic visual acuity chart, reported as LogMAR score.	Baseline, and at 1, 2, 3, and 6 months after treatment
Superficial retinal capillary plexus vessel density(VD-SCP)	Superficial retinal capillary plexus vessel density (VD-SCP) measured by OCTA, reported as percentage (%) of vessel area.	Baseline, and at 1, 2, 3, and 6 months after treatment
Deep retinal capillary plexus vessel density (VD-DCP)	Deep retinal capillary plexus vessel density (VD-DCP) measured by OCTA, reported as percentage (%) of vessel area.	Baseline, and at 1, 2, 3, and 6 months after treatment
Foveal Avascular Zone area(FAZ)	Foveal Avascular Zone area(FAZ) measured by Optical Coherence Tomography Angiography (OCTA) in Square millimeters (mm²).	Baseline, and at 1, 2, 3, and 6 months after treatment
Ganglion Cell Layer Thickness(GCL)	Ganglion Cell Layer Thickness(GCL) measured by Optical Coherence Tomography Angiography (OCTA) in micrometers (μm).	Baseline, and at 1, 2, 3, and 6 months after treatment
Ganglion Cell-Inner Plexiform Layer Thickness	Ganglion Cell-Inner Plexiform Layer Thickness measured by Optical Coherence Tomography Angiography (OCTA) in micrometers (μm).	Baseline, and at 1, 2, 3, and 6 months after treatment
Carotid plaque	Presence of carotid plaque (yes/no) measured by B-mode ultrasound.	Baseline, and at 3 and 6 months after treatment
Retinal circulation time	Retinal circulation time measured by fundus fluorescein angiography (FFA) in Seconds (s)- typically arm-to-retina circulation time.	Baseline, and at 3 and 6 months after treatment
Retrobulbar blood flow	Retrobulbar blood flow parameters measured by color Doppler ultrasound include peak systolic velocity (PSV, cm/s) and end-diastolic velocity (EDV, cm/s) and resistive index (RI).	Baseline, and at 3 and 6 months after treatment
Gut microbiota	Gut microbiota measured by 16S rRNA sequencing include Alpha diversity (e.g., Shannon index) or Relative abundance of specific taxa (%).	Baseline, and at 1, 2, 3, and 6 months after treatment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Temperature	Temperature measured by an electronic thermometer in degrees Celsius (°C).	Baseline, and at 3 and 6 months after treatment
Heart rate	Heart rate measured by automatic blood pressure monitor in beats per minute (bpm).	Baseline, and at 3 and 6 months after treatment
Blood pressure	Blood pressure measured by automatic blood pressure monitor in Millimeters of mercury (mmHg) - report systolic and diastolic values separately.	Baseline, and at 3 and 6 months after treatment
Complete Blood Count	Complete Blood Count, including white blood cell count (×10⁹/L), red blood cell count (×10¹²/L), hemoglobin (g/L), and platelet count (×10⁹/L), will be assessed via blood draw.	Baseline, and at 3 and 6 months after treatment
Urinalysis	Urinalysis, performed on collected urine samples, includes measurements of protein (g/L), glucose (mmol/L), and red blood cells (/μL).	Baseline, and at 3 and 6 months after treatment
Liver and Renal Function Tests	Liver function parameters (ALT and AST, in U/L) and renal function parameters (Cr and BUN, in μmol/L and mmol/L, respectively) will be measured via blood draw.	Baseline, and at 3 and 6 months after treatment
Coagulation Profile	Blood samples will be collected to assess coagulation profile, including prothrombin time (PT, in seconds), activated partial thromboplastin time (APTT, in seconds), thrombin time (TT, in seconds), and fibrinogen (FIB, in g/L).	Baseline, and at 3 and 6 months after treatment
Cardiac function	Electrocardiogram (ECG) will be used to evaluate cardiac function, with the following parameters recorded: heart rate (bpm), PR interval (ms), QRS duration (ms), and QT interval (ms).	Baseline, and at 3 and 6 months after treatment

Collaborators and Investigators

• Sponsor: First Affiliated Hospital of Zhejiang University
• Collaborators: Zhejiang Provincial Tongde Hospital; The Fourth Affiliated Hospital of Zhejiang University School of Medicine
• Investigators: Principal Investigator: Hongguang Cui, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: June 2, 2026
• First Submitted That Met QC Criteria: July 17, 2026
• First Posted (Actual): July 22, 2026

Study Record Updates

• Last Update Posted (Actual): July 22, 2026
• Last Update Submitted That Met QC Criteria: July 17, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Conbercept; Traditional Chinese Medicine; Tongluo Huayu Formula
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Eye Diseases; Embolism and Thrombosis; Retinal Diseases; Venous Thrombosis; Thrombosis; Retinal Vein Occlusion
• Other Study ID Numbers: IIT20260045C-R1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) will not be shared with external researchers. The raw clinical data collected in this trial only serves for internal statistical analysis and scientific research of the research team, and there is no relevant data sharing plan at present.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No