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The clinical research of Shuiguitie conbined with tolvaptan treating on cirrhosis with refractory ascites

The clinical research of Shuiguitie conbined with tolvaptan treating on cirrhosis with refractory ascites

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-INR-16009401
Enrollment
Unknown
Registered
2016-10-14
Start date
2016-10-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

cirrhosis with refractory ascites

Interventions

Treatment group:Shuiguitie topical plus tolvaptan 15mg po
control group:Shuiguitie topical placebo plus tolvaptan 15mg po

Sponsors

Shanghai Municipal Hospital of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Volunteer to be as the subject; 2. in line with diagnostic criteria of the refractory liver cirrhosis; 3. in line with Chinese medicine syndrome of edema from deficiency in the spleen or yang deficiency of the spleen and kidney; 4. To be aged 18 to 65 years old.

Exclusion criteria

Exclusion criteria: 1. cirrhosis with infection or ascites caused by malignant tumors; 2.suffered with upper gastrointestinal bleeding or hepatic encephalopathy in 2 weeks; 3. complication with severe diseases (i.e. cardiovascular, renal and hematopoietic system ), mental defects, or asthma; 4. total bilirubin = 50umol/L or chronic or acute liver failure (PTA = 40%, or total daily bilirubin increased = 17.1umol / L); 5. serum albumin less than 25g / L.

Design outcomes

Primary

MeasureTime frame
Ascites volume;Urine output;supine abdominal circumference maximum;weight;

Secondary

MeasureTime frame
Chinese Medical Syndrome scores;liver function;Blood sodium;Urine sodium;creatinine clearance rate;

Countries

China

Contacts

Public ContactZHU Junfeng

Shanghai Municipal Hospital of Traditional Chinese Medicine

7140@szy.sh.cn+86 18116013369

Outcome results

None listed

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