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

Phase 1

Recruiting

• Conditions: Infectious and non infectious cirrhosis, alcoholic cirrhosis,and ascites; H0317.????\?????????, H0314.???????????,H0315.??\????????????,H0316.????????; ???? ???? C1105

• Registration Number: ITMCTR2100004226
• Lead Sponsor: Department of Infectious Disease, The First Affiliated Hospital of He'nan University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

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.
4. CT showed nodular protrusion on the outer edge of liver, enlarged hepatic fissure, larger than 0.05 in the caudate lobe compared with the right lobe, and splenomegaly.
5. Liver biopsy or laparoscopic biopsy confirmed cirrhosis.
For the differentiation of compensated and decompensated liver cirrhosis, please refer to the guideline for diagnosis and treatment of liver cirrhosis (2019 Edition) of Hepatology branch of Chinese Medical Association.

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.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Abdominal puncture examination: ascites routine, ascites biochemistry, ascites culture, serum ascites albumin gradient;;Main symptoms and signs: observe the changes of the patient's symptoms, such as fatigue, anorexia, hypochondriac pain, abdominal distension, jaundice, hepatosplenomegaly, etc., and observe the changes of patient's physical signs, such as weight, abdominal circumference, leg circumference, 24-hour urine volume, etc;;Serological indexes: routine blood test, liver function (alt, AST, GGT, ALP, TBIL, ALB, PA), coagulation function (PT, INR), liver fibrosis (HA, LN, PC III and IV - C);

Secondary Outcome Measures

Name	Time	Method
Child Pugh score: according to hepatic encephalopathy, ascites, total bilirubin, albumin and prothrombin time, child Pugh score would be calculated according to serum bilirubin, creatinine (SCR), INR and liver etiology;;