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NCT Number: NCT07718503

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

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.

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Key information

Conditions

Retinal Vein Occlusion Cardiovascular Diseases Embolism and Thrombosis Eye Diseases Retinal Diseases Thrombosis Vascular Diseases Venous Thrombosis

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310003, China

Location contact

Wei Zhou

CONTACT

[email protected]

18101092595

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Conbercept Ophthalmic Injection

Drug

Intravitreal injection of Conbercept will be administered once a month for 3 consecutive months.

Tongluo Huayu Formula

Other

The Tongluo Huayu Formula will be administered for 1 month.

Laser Photocoagulation

Procedure

Laser photocoagulation will be administered if large areas of retinal non-perfusion or fundus neovascularization occur.

Primary outcomes

  1. Central Macular Thickness（CMT）

    Time frame: Baseline, and at 1, 2, 3, and 6 months after treatment.

    Central Macular Thickness (CMT) measured by Optical Coherence Tomography Angiography (OCTA) in micrometers (μm).

Secondary outcomes

  1. Best Corrected Visual Acuity(BCVA)

    Time frame: Baseline, and at 1, 2, 3, and 6 months after treatment

    Best Corrected Visual Acuity (BCVA) assessed using the standard logarithmic visual acuity chart, reported as LogMAR score.

  2. Superficial retinal capillary plexus vessel density(VD-SCP)

    Time frame: Baseline, and at 1, 2, 3, and 6 months after treatment

    Superficial retinal capillary plexus vessel density (VD-SCP) measured by OCTA, reported as percentage (%) of vessel area.

  3. Deep retinal capillary plexus vessel density (VD-DCP)

    Time frame: Baseline, and at 1, 2, 3, and 6 months after treatment

    Deep retinal capillary plexus vessel density (VD-DCP) measured by OCTA, reported as percentage (%) of vessel area.

  4. Foveal Avascular Zone area(FAZ)

    Time frame: Baseline, and at 1, 2, 3, and 6 months after treatment

    Foveal Avascular Zone area(FAZ) measured by Optical Coherence Tomography Angiography (OCTA) in Square millimeters (mm²).

  5. Ganglion Cell Layer Thickness(GCL)

    Time frame: Baseline, and at 1, 2, 3, and 6 months after treatment

    Ganglion Cell Layer Thickness(GCL) measured by Optical Coherence Tomography Angiography (OCTA) in micrometers (μm).

  6. Ganglion Cell-Inner Plexiform Layer Thickness

    Time frame: Baseline, and at 1, 2, 3, and 6 months after treatment

    Ganglion Cell-Inner Plexiform Layer Thickness measured by Optical Coherence Tomography Angiography (OCTA) in micrometers (μm).

  7. Carotid plaque

    Time frame: Baseline, and at 3 and 6 months after treatment

    Presence of carotid plaque (yes/no) measured by B-mode ultrasound.

  8. Retinal circulation time

    Time frame: Baseline, and at 3 and 6 months after treatment

    Retinal circulation time measured by fundus fluorescein angiography (FFA) in Seconds (s)- typically arm-to-retina circulation time.

  9. Retrobulbar blood flow

    Time frame: Baseline, and at 3 and 6 months after treatment

    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).

  10. Gut microbiota

    Time frame: Baseline, and at 1, 2, 3, and 6 months after treatment

    Gut microbiota measured by 16S rRNA sequencing include Alpha diversity (e.g., Shannon index) or Relative abundance of specific taxa (%).

Other outcomes

  1. Temperature

    Time frame: Baseline, and at 3 and 6 months after treatment

    Temperature measured by an electronic thermometer in degrees Celsius (°C).

  2. Heart rate

    Time frame: Baseline, and at 3 and 6 months after treatment

    Heart rate measured by automatic blood pressure monitor in beats per minute (bpm).

  3. Blood pressure

    Time frame: Baseline, and at 3 and 6 months after treatment

    Blood pressure measured by automatic blood pressure monitor in Millimeters of mercury (mmHg) - report systolic and diastolic values separately.

  4. Complete Blood Count

    Time frame: Baseline, and at 3 and 6 months after treatment

    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.

  5. Urinalysis

    Time frame: Baseline, and at 3 and 6 months after treatment

    Urinalysis, performed on collected urine samples, includes measurements of protein (g/L), glucose (mmol/L), and red blood cells (/μL).

  6. Liver and Renal Function Tests

    Time frame: Baseline, and at 3 and 6 months after treatment

    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.

  7. Coagulation Profile

    Time frame: Baseline, and at 3 and 6 months after treatment

    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).

  8. Cardiac function

    Time frame: Baseline, and at 3 and 6 months after treatment

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Wei Zhou

CONTACT

[email protected]

18101092595

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital of Zhejiang University

Other

Collaborators

  • The Fourth Affiliated Hospital of Zhejiang University School of Medicine
  • Zhejiang Provincial Tongde Hospital

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jul 22, 2026
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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