Clinical study on Rhubarb decoction retention enema in the treatment of liver cirrhosis with spontaneous bacterial peritonitis

Phase 1

Recruiting

• Conditions: spontaneous bacterial peritonitis,SBP

• Registration Number: ITMCTR2000004042
• Lead Sponsor: Shanghai Hospital of Traditional Chinese Medicine

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: Male
• Target Recruitment: Not specified

Inclusion Criteria

1. diagnostic criteria of Western medicine:
(1) According to the guidelines for the prevention and treatment of chronic hepatitis B (CHB) formulated by the hepatology branch of Chinese Medical Association in 2015, liver cirrhosis is usually divided into compensatory and decompensated stages according to the main complications. The imaging, biochemical or hematological examination of compensated cirrhosis showed evidence of dysfunction of hepatocyte synthesis or portal hypertension (such as hypersplenism and esophageal and gastric varices), or histology was consistent with the diagnosis of liver cirrhosis, but there were no severe complications such as rupture and bleeding of esophageal and gastric varices, ascites or hepatic encephalopathy. Decompensated cirrhosis can cause esophageal varices bleeding, hepatic encephalopathy, ascites and other serious complications.
In order to more accurately predict the disease progression and determine the risk of death in patients with liver cirrhosis, the complications of liver cirrhosis can be evaluated according to the five stage classification:
Stage 1: no varicose veins and no ascites;
stage 2: varicose veins, no bleeding and ascites;
stage 3: ascites, no bleeding, with or without varicose veins;
stage 4: bleeding with or without ascites;
stage 5: sepsis.
1. Stage 2 was compensatory cirrhosis, and stage 3 to 5 was decompensated cirrhosis.
1. The 1-year mortality of stage 2, 3, 4 and 5 was < 1%, 3% - 4%, 20%, 50% and 60%, respectively. The occurrence of complications is closely related to the prognosis and death risk of patients with liver cirrhosis. Child Pugh classification: according to hepatic encephalopathy, ascites, serum total bilirubin, serum white, Protein and prothrombin time were used to evaluate the liver function and reflect the severity of the disease.
(2) According to the 2010 EASL guidelines for clinical practice of spontaneous bacterial peritonitis in liver cirrhosis, the number of neutrophils in ascites was more than 0.25x10^9/L.
2. diagnostic criteria of TCM syndrome types:
Refer to the syndrome of dampness heat accumulating spleen and blood stasis in the guiding principles of clinical research of new Chinese medicine (Trial) published by China Pharmaceutical Science and Technology Press in 2002. Syndrome of dampness heat accumulating spleen;
Main symptoms: abdominal distension, thirst less drink, less food, loose stool and uncomfortable, red tongue, yellow greasy tongue coating;
Secondary symptoms: the limbs are sleepy and heavy, the body is not hot or sweating is not clear, abdominal distension is full, nausea and vomiting, body eyes are yellow and bright, and the pulse is infiltrated. Blood stasis syndrome:
Main symptoms: tingling, pain has a fixed place, refused to press, vein congestion (such as lips, gingiva, claw nail dark, skin surface red, or abdominal wall blue veins exposed), subcutaneous ecchymosis, symptom accumulation, blood from menstruation, tongue purple dark or with ecchymosis, petechia, tongue pulse is rough, pulse is astringent, no pulse or sink string, string late;
Secondary symptoms: skin nail fault, limb numbness or hemiplegia, madness, forgetfulness, local sensory abnormalities, history of trauma, surgery and artificial abortion.
The syndrome of dampness heat accumulating spleen should be diagnosed according to 3 items of main syndrome (necessary for tongue image), or 2 items for main syndrome (necessary for ton

Exclusion Criteria

(1) Complications such as gastrointestinal bleeding, hepatic encephalopathy, hepatorenal syndrome or liver cancer were found;
(2) Acute and chronic pancreatitis, multiple organ failure, abdominal trauma, peptic ulcer perforation and inflammatory bowel disease affect intestinal function;
(3) Ascites caused by cardiogenic, nephrogenic, dystrophic, malignant tumor peritoneal metastasis, ovarian tumor, connective tissue disease, etc. other than liver diseases; cancerous peritonitis, tuberculous peritonitis, secondary peritonitis (surgical acute abdomen, abdominal trauma, surgery, etc.);
(4) Combined with other chronic diseases, such as heart, brain, kidney and other important organs and endocrine and blood system diseases;
(5) Antibiotics, probiotics, immunomodulators and traditional Chinese medicine were used in 8 weeks before treatment; (6) Pregnant women and lactating women with age less than 18 years old or over 80 years old;
(7) There are contraindications to enema;
(8) Mental, psychological or neurological disorders;
(9) Combined with other serious infectious diseases, such as tuberculosis, AIDS, etc;
(10) Hypersensitivity to a variety of drugs;
(11) They were not willing to participate in the experiment and sign informed consent.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
routine blood test;