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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

2026年7月17日 更新者：First Affiliated Hospital of Zhejiang University

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.

研究概览

地位

尚未招聘

条件

干预/治疗

研究类型

介入性

注册 (估计的)

80

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 中国
    • Zhejiang
      • Hangzhou、Zhejiang、中国、310003
        • The First Affiliated Hospital, Zhejiang University School of Medicine
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Experimental Group
Combined TCM and Western Medicine
药品：Conbercept Ophthalmic Injection
Intravitreal injection of Conbercept will be administered once a month for 3 consecutive months.
其他：Tongluo Huayu Formula
The Tongluo Huayu Formula will be administered for 1 month.
程序：Laser Photocoagulation
Laser photocoagulation will be administered if large areas of retinal non-perfusion or fundus neovascularization occur.
有源比较器：Control Group
Conventional Western Medicine Only
药品：Conbercept Ophthalmic Injection
Intravitreal injection of Conbercept will be administered once a month for 3 consecutive months.
程序：Laser Photocoagulation
Laser photocoagulation will be administered if large areas of retinal non-perfusion or fundus neovascularization occur.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Central Macular Thickness（CMT）
大体时间：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).
Baseline, and at 1, 2, 3, and 6 months after treatment.

次要结果测量

结果测量
措施说明
大体时间
Best Corrected Visual Acuity(BCVA)
大体时间：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.
Baseline, and at 1, 2, 3, and 6 months after treatment
Superficial retinal capillary plexus vessel density(VD-SCP)
大体时间：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.
Baseline, and at 1, 2, 3, and 6 months after treatment
Deep retinal capillary plexus vessel density (VD-DCP)
大体时间：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.
Baseline, and at 1, 2, 3, and 6 months after treatment
Foveal Avascular Zone area(FAZ)
大体时间：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).
Baseline, and at 1, 2, 3, and 6 months after treatment
Ganglion Cell Layer Thickness(GCL)
大体时间：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).
Baseline, and at 1, 2, 3, and 6 months after treatment
Ganglion Cell-Inner Plexiform Layer Thickness
大体时间：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).
Baseline, and at 1, 2, 3, and 6 months after treatment
Carotid plaque
大体时间：Baseline, and at 3 and 6 months after treatment
Presence of carotid plaque (yes/no) measured by B-mode ultrasound.
Baseline, and at 3 and 6 months after treatment
Retinal circulation time
大体时间：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.
Baseline, and at 3 and 6 months after treatment
Retrobulbar blood flow
大体时间：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).
Baseline, and at 3 and 6 months after treatment
Gut microbiota
大体时间：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 (%).
Baseline, and at 1, 2, 3, and 6 months after treatment

其他结果措施

结果测量
措施说明
大体时间
Temperature
大体时间：Baseline, and at 3 and 6 months after treatment
Temperature measured by an electronic thermometer in degrees Celsius (°C).
Baseline, and at 3 and 6 months after treatment
Heart rate
大体时间：Baseline, and at 3 and 6 months after treatment
Heart rate measured by automatic blood pressure monitor in beats per minute (bpm).
Baseline, and at 3 and 6 months after treatment
Blood pressure
大体时间：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.
Baseline, and at 3 and 6 months after treatment
Complete Blood Count
大体时间：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.
Baseline, and at 3 and 6 months after treatment
Urinalysis
大体时间：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).
Baseline, and at 3 and 6 months after treatment
Liver and Renal Function Tests
大体时间：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.
Baseline, and at 3 and 6 months after treatment
Coagulation Profile
大体时间：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).
Baseline, and at 3 and 6 months after treatment
Cardiac function
大体时间：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).
Baseline, and at 3 and 6 months after treatment

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

First Affiliated Hospital of Zhejiang University

合作者

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

调查人员

  • 首席研究员：Hongguang Cui、Zhejiang University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年6月1日

初级完成 (估计的)

2028年12月1日

研究完成 (估计的)

2028年12月31日

研究注册日期

首次提交

2026年6月2日

首先提交符合 QC 标准的

2026年7月17日

首次发布 (实际的)

2026年7月22日

研究记录更新

最后更新发布 (实际的)

2026年7月22日

上次提交的符合 QC 标准的更新

2026年7月17日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • IIT20260045C-R1

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

IPD 计划说明

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.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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