Evaluation of the clinical curative effect of Wenyang Lishui Therapy in the treatment of refractory ascites due to liver cirrhosis

Phase 1

Recruiting

• Conditions: Refractory ascites due to cirrhosis

• Registration Number: ITMCTR2000003996
• Lead Sponsor: Shuguang Hospital Affiliated to Shanghai University 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: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Male or female aged 18-80 years;
2. The western medicine diagnosis is cirrhosis refractory ascites, and the traditional Chinese medicine diagnosis is distension, the syndrome type conforms to the spleen and kidney yang deficiency syndrome.
Diagnostic criteria of Western medicine:
1. Diagnostic criteria of decompensated cirrhosis
(1) B ultrasound diagnosis of liver cirrhosis
(2) Complications of portal hypertension and / or liver dysfunction: child Pugh B / C grade; ascites, esophageal variceal bleeding, sepsis, hepatic encephalopathy, hepatorenal syndrome
2. Diagnostic criteria of ascites in refractory cirrhosis
(1) There was no response in ascites (4-6 g / D) with large diuretics (160 mg / D in snail and 80 mg / D in furosemide) for at least 1 week or intermittent therapeutic ascites drainage (4000-5000ml / time) combined with albumin (20-40g / time) for 2 weeks. Ascites did not respond to treatment (i.e. body weight decreased by less than 0.8kg/d, urinary sodium excretion was less than 50meq / D) or the ascites that had been controlled recurred within 4 weeks At least Grade 1);
(2) There were complications or adverse reactions related to diuretics that were difficult to control.
Diagnostic criteria of traditional Chinese Medicine
According to the diagnostic criteria of traditional Chinese medicine bloating, the main manifestations are abdominal fullness, short urine, even big abdomen, pale skin and exposed veins. The syndrome type accords with the deficiency of spleen and kidney yang.
Main symptoms: abdominal distension and fullness, like frog abdomen; abdominal distension early light, dusk heavy; limb cold;
Secondary symptoms: white complexion, swelling of limbs, soreness and weakness of waist and knee, cold pain in abdomen.
Tongue vein: the tongue is light and fat, or has teeth marks, the moss is thin and white, and the pulse is deep and stringy.
Diagnosis: there are 2 main symptoms and 2 secondary symptoms, or 3 secondary symptoms in the first major symptom.

Exclusion Criteria

1. Patients with serious heart, lung, kidney, nervous system, blood system, psychosis and tumor (liver tumor only exclude those complicated with bloody ascites);
2. Patients with diabetes whose blood sugar is difficult to control;
3. Patients with liver cirrhosis complicated with upper gastrointestinal bleeding, grade 2 or higher hepatic encephalopathy.
4. Pregnant and lactating women;
5. Patients allergic to Zhenwu decoction;
6. Patients who are participating in other clinical trials.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
weight;Urine sodium;Depth of ascites;Ascites remission rate;Abdominal circumference;

Secondary Outcome Measures

Name	Time	Method
RASS related indicators;MAP;