ITMCTR2100004226
Recruiting
Phase 1
Clinical observation and treatment of various types of inflammatory cirrhosis ascites by a combination of herb forms under the mainstream medicine with novel abdominal patches and related inventories
Department of Infectious Disease, The First Affiliated Hospital of He'nan University0 sitesTBD
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Department of Infectious Disease, The First Affiliated Hospital of He'nan University
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Referring to the guideline for diagnosis and treatment of cirrhotic ascites and related complications formulated by the hepatology branch of the Chinese Medical Association in 2017, the spleen and stomach disease branch of the Chinese Medical Association issued the consensus opinions of TCM diagnosis and treatment of cirrhotic ascites (2017\)
- •1\. Liver cirrhosis patients caused by hepatitis virus infection: such as chronic hepatitis B and hepatitis C; liver cirrhosis patients caused by alcoholic liver disease and nonalcoholic fatty liver disease; 2;
- •2\. Any one of a, B and C in child Pugh score;
- •3\. Aged 18\-75 years;
- •4\. The person who signed the informed consent.
- •In addition to the fifth major indication, any other additional minor indication can be diagnosed as cirrhosis.
- •Main indications:
- •1\. Imaging examination: liver color Doppler ultrasound showed that the liver echo was uneven, significantly enhanced, and the light spot was thick; or the liver surface was not smooth, uneven or serrated; or the diameter of portal vein was more than 1\.4cm, the portal collateral branch was open, or the spleen was enlarged, and the diameter of splenic vein was more than 1\.0cm.
- •2\. Esophagogastric varices can be seen by endoscopy or barium swallow X\-ray examination.
- •3\. Ascites may be accompanied by abdominal varicose veins.
Exclusion Criteria
- •1\. Patients complicated with or overlapped with other viral hepatitis such as a, C, e, D, etc;
- •2\. Patients with autoimmune liver disease (PBC, primary sclerosing cholangitis, autoimmune hepatitis), drugs or chemical poisons, schistosomiasis liver disease, genetic metabolic diseases, circulatory disorders (Budd Chiari syndrome, right heart failure), cryptogenic cirrhosis and other diseases;
- •3\. Patients with severe complications such as esophageal variceal bleeding, spontaneous peritonitis, hepatic encephalopathy, hepatorenal syndrome and primary liver cancer;
- •4\. Patients with serious multiple diseases, such as cardiovascular, lung, kidney, brain, endocrine and hematopoietic system, severe primary diseases, psychosis and other intolerant subjects;
- •5\. Pregnant and lactating women;
- •6\. Patients allergic to the drug.
Outcomes
Primary Outcomes
Not specified
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