Endoscopic and Microbiological Assessment of the Effect of Carvedilol Combined With Berberine on … (NCT04543643) | Clinical Trial Compass
UnknownPhase 3
Endoscopic and Microbiological Assessment of the Effect of Carvedilol Combined With Berberine on GOV in Cirrhosis
China288 participantsStarted 2021-11-01
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion Criteria:
* HBV-related or/and HCV-related liver cirrhotic patients based on pathology or clinical diagnosis;
* Antiviral therapy;
* Male or Female;
* ES showed the presence of esophageal and gastric varices and / or red signs;
* Child-Pugh \< 10, and meld \< 29;
* Signature of informed consent.
Exclusion Criteria:
* • Used antibiotics, prebiotics, probiotics and proton pump inhibitors within 2 weeks;
* Any contra-indications to beta-blockers including asthma, chronic obstructive pulmonary disease, allergic rhinitis, NYHA (New York Heart Association) class IV heart failure, atrioventricular block, sinus bradycardia (HR \< 50 / min), cardiogenic shock, hypotension (SBP \< 85mmHg), sick sinus syndrome, insulin dependent diabetes, peripheral vascular disease;
* Unstable high blood pressure and long-term engagement in driving;
* Any malignancy that affects survival, excluding the cured;
* Patients with portal thrombosis;
* PT extension greater than 4 seconds, PLT\<30×10\^9/L;
* Pregnant and lactating patients;
* History of surgery for portal hypertensionï¼›History of prior EVL (endoscopic variceal ligation) or sclerotherapy, history of surgery for portal hypertension including portosystemic shunts, disconnection and spleen resection and transjugular intrahepatic portosystemic shunt;
* Patients with severe diseases of vital organs such as heart, lung, kidney, brain, blood and nervous system;
* Allergic to carvedilol and berberine;
* Sever…