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 juillet 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Estimé)
80
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Wei Zhou
- Numéro de téléphone: 18101092595
- E-mail: 15575924800@163.com
Lieux d'étude
-
-
Zhejiang
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Hangzhou, Zhejiang, Chine, 310003
- The First Affiliated Hospital, Zhejiang University School of Medicine
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Contact:
- Wei Zhou
- Numéro de téléphone: 18101092595
- E-mail: 15575924800@163.com
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La 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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Experimental Group
Combined TCM and Western Medicine
|
Intravitreal injection of Conbercept will be administered once a month for 3 consecutive months.
The Tongluo Huayu Formula will be administered for 1 month.
Laser photocoagulation will be administered if large areas of retinal non-perfusion or fundus neovascularization occur.
|
|
Comparateur actif: Control Group
Conventional Western Medicine Only
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Intravitreal injection of Conbercept will be administered once a month for 3 consecutive months.
Laser photocoagulation will be administered if large areas of retinal non-perfusion or fundus neovascularization occur.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Central Macular Thickness（CMT）
Délai: 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.
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Best Corrected Visual Acuity(BCVA)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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).
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Baseline, and at 1, 2, 3, and 6 months after treatment
|
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Ganglion Cell Layer Thickness(GCL)
Délai: 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
|
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Ganglion Cell-Inner Plexiform Layer Thickness
Délai: 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
|
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Carotid plaque
Délai: Baseline, and at 3 and 6 months after treatment
|
Presence of carotid plaque (yes/no) measured by B-mode ultrasound.
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Baseline, and at 3 and 6 months after treatment
|
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Retinal circulation time
Délai: 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
|
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Retrobulbar blood flow
Délai: 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
Délai: 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
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Temperature
Délai: 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
Délai: 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
|
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Blood pressure
Délai: 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.
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Baseline, and at 3 and 6 months after treatment
|
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Complete Blood Count
Délai: 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
|
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Urinalysis
Délai: 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
|
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Liver and Renal Function Tests
Délai: 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
|
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Coagulation Profile
Délai: 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
|
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Cardiac function
Délai: 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
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Collaborateurs
Les enquêteurs
- Chercheur principal: Hongguang Cui, Zhejiang University
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
1 juin 2026
Achèvement primaire (Estimé)
1 décembre 2028
Achèvement de l'étude (Estimé)
31 décembre 2028
Dates d'inscription aux études
Première soumission
2 juin 2026
Première soumission répondant aux critères de contrôle qualité
17 juillet 2026
Première publication (Réel)
22 juillet 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
22 juillet 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
17 juillet 2026
Dernière vérification
1 mai 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- IIT20260045C-R1
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Description du régime 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.
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .