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 range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 hypertension；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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The progression Incidence of esophageal varices

Timeframe: 1 year

Trial details

NCT IDNCT04543643

SponsorTianjin Second People's Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-10-31

Contact for this trial

Han Ping, bachelor

13652139315 13652139315@163.com

View on ClinicalTrials.gov More Cirrhosis Due to Hepatitis B trials