NCT04543643

Endoscopic and Microbiological Assessment of the Effect of Carvedilol Combined With Berberine on GOV in Cirrhosis

Endoscopic and Microbiological Assessment of the Effect of Carvedilol Combined With Berberine on GOV in Cirrhosis: a Prospective Cohort Study

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 288 (estimated)
• Sponsor: Tianjin Second People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Carvedilol has been shown to be more potent in decreasing portal hypertension to propranolol. A lot of studies have shown that the imbalance of flora and the progress of portal hypertension are mutually causal. Berberine can regulate the intestinal flora.In this study, we evaluated the effect of carvedilol and berberine on reducing portal vein pressure by observing the changes of endoscopy，endoscopic ultrasonography and intestinal flora.

Detailed description

There is a higher risk of esophageal and gastric varices bleeding in cirrhosis patients with moderate and severe esophageal and gastric varices. Once there is a high mortality rate of esophageal and gastric varices bleeding, it will cause great losses to the family and society. Therefore, it is of great social and economic significance to prevent esophageal and gastric varices bleeding through economic and effective methods. As the third generation of NSBB, carvedilol is more effective in reducing HVPG than propranolol, which is recommended by Baveno VI as the first-line drug for EVB primary prevention. A lot of studies have shown that the imbalance of flora and the progress of portal hypertension are mutually causal. The application of carvedilol can reduce the pressure of portal vein, and when the portal hypertension is improved, the imbalance of intestinal mucosal barrier and flora will also be changed. Berberine can regulate the intestinal flora, which is safe and effective in clinical application. Gastroscopy is still the main method of screening varicose veins. We can determine whether there is GOV in patients and evaluate the risk of varicose vein bleeding. However, gastroscopy can only observe the situation in the digestive tract lumen, and ultrasound endoscopy can scan the outside of the tube wall, so as to more comprehensively evaluate the change of portal hypertension. The purpose of this study is to apply endoscopic ultrasonography to the whole process of the study, which can be used as a more sensitive means to observe the changes of portal hypertension, and to systematically evaluate the continuous changes of portal hypertension. It provides a theoretical basis and measurement means for a more comprehensive and scientific evaluation of portal hypertension.In this study, the patients with GOV who need primary prevention were randomly divided into two groups. Carvedilol or carvedilol combined with berberine were given for 12 months respectively. The degree of varicose vein relief was judged by ES and EUS, and the changes of oral and intestinal flora were detected at the same time To understand the possible mechanism of carvedilol and berberine in reducing portal hypertension.

Conditions

• Cirrhosis Due to Hepatitis B
• Cirrhosis Due to Hepatitis C
• Gastroesophageal Varices

Interventions

Type	Name	Description
DRUG	Carvedilol	As the third generation of NSBB, carvedilol is more effective in reducing HVPG than propranolol, which is recommended by Baveno VI as the first-line drug for EVB primary prevention.
DRUG	Berberine	Berberine can regulate the intestinal flora, which is safe and effective in clinical application.

Timeline

• Start date: 2021-11-01
• Primary completion: 2023-10-31
• Completion: 2023-10-31
• First posted: 2020-09-10
• Last updated: 2021-10-25

Locations

1 site across 1 country: China