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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

17 de julho de 2026 atualizado por: 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.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Estimado)

80

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310003
        • The First Affiliated Hospital, Zhejiang University School of Medicine
        • Contato:

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Experimental Group
Combined TCM and Western Medicine
Medicamento: Conbercept Ophthalmic Injection
Intravitreal injection of Conbercept will be administered once a month for 3 consecutive months.
Outro: Tongluo Huayu Formula
The Tongluo Huayu Formula will be administered for 1 month.
Procedimento: Laser Photocoagulation
Laser photocoagulation will be administered if large areas of retinal non-perfusion or fundus neovascularization occur.
Comparador Ativo: Control Group
Conventional Western Medicine Only
Medicamento: Conbercept Ophthalmic Injection
Intravitreal injection of Conbercept will be administered once a month for 3 consecutive months.
Procedimento: Laser Photocoagulation
Laser photocoagulation will be administered if large areas of retinal non-perfusion or fundus neovascularization occur.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Central Macular Thickness（CMT）
Prazo: 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.

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Best Corrected Visual Acuity(BCVA)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
Temperature
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

First Affiliated Hospital of Zhejiang University

Colaboradores

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

Investigadores

  • Investigador principal: Hongguang Cui, Zhejiang University

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

1 de junho de 2026

Conclusão Primária (Estimado)

1 de dezembro de 2028

Conclusão do estudo (Estimado)

31 de dezembro de 2028

Datas de inscrição no estudo

Enviado pela primeira vez

2 de junho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

17 de julho de 2026

Primeira postagem (Real)

22 de julho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

22 de julho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

17 de julho de 2026

Última verificação

1 de maio de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • IIT20260045C-R1

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Descrição do plano IPD

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.

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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