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

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

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000037108
Enrollment
Unknown
Registered
2020-08-27
Start date
2020-10-01
Completion date
Unknown
Last updated
2020-10-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Refractory ascites due to cirrhosis

Interventions

Sponsors

Shuguang Hospital Affiliated to Shanghai University of traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Ascites remission rate;Depth of ascites;Abdominal circumference;weight;Urine sodium;

Secondary

MeasureTime frame
MAP;RASS related indicators;

Countries

China

Contacts

Public ContactShuJuan Lei

Shuguang Hospital Affiliated to Shanghai University of traditional Chinese Medicine

15900986320@163.com+86 15900986320

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026