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Clinical study on the prevention of recurrence of ascites in patients with hepatitis B virus-related cirrhosis by Strengthening Spleen and Tonifying Kidney Granules

Study on a programme to prevent recurrence of ascites in patients with hepatitis B virus-related cirrhosis based on Strengthening Spleen and Tonifying Kidney Granules

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300079093
Enrollment
Unknown
Registered
2023-12-25
Start date
2024-01-01
Completion date
Unknown
Last updated
2024-01-08

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

Conditions

Ascites in hepatitis B virus-related cirrhosis

Interventions

Test group:Basic internal medicine treatment plus Strengthening Spleen and Tonifying Kidney Granules
Control group:Basic internal medicine treatment plus placebo

Sponsors

The First Affiliated Hospital of Henan University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) Aged 18 to 65 years. (2) Meet the diagnostic criteria for ascites in hepatitis B-related cirrhosis and spleen and kidney deficiency. (3) Disappearance or maximum depth of ascites less than 3 cm on ultrasound after comprehensive medical treatment. (4) Voluntarily participate in the research, sign the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Those who are participating in other clinical studies. (2) Liver failure. (3) Combined with complications such as hepatic encephalopathy, hepatorenal syndrome, upper gastrointestinal bleeding, and spontaneous peritonitis. (4) Primary liver cancer, or tumours in other parts of the body. (5) Allergy to a certain component of this formula. (6) Severe cardiac, renal, pulmonary, cerebral, diabetic and other fundamental diseases, ascites due to constrictive pericarditis, tuberculous peritonitis, and tumours. (7) Pregnant or lactating women. (8) Patients after transjugular intrahetic portosystemicshunt (Tips). (9) Other conditions that the investigator considers inappropriate for enrolment.

Design outcomes

Primary

MeasureTime frame
Recurrence rate of ascites;

Secondary

MeasureTime frame
Number of days sustained without recurrence of ascites;Maximum depth of ascites in the lower abdomen on ultrasound;serum albumin;serum pre-albumin;serum cholinesterase;symptoms;

Countries

China

Contacts

Public ContactSuping Ma

The First Affiliated Hospital of Henan University of Chinese Medicine

masuping@163.com+86 371 6624 4588

Outcome results

None listed

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