Skip to content

PK-PD (pharmacokinetic-pharmacodynamic) study for Huangqi decoction in patients with cirrhosis

PK-PD (pharmacokinetic-pharmacodynamic) study for Huangqi decoction in patients with cirrhosis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800018976
Enrollment
Unknown
Registered
2018-10-20
Start date
2018-10-15
Completion date
Unknown
Last updated
2018-10-22

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

Conditions

Cirrhosis

Interventions

1:Huangqi Decoction
2:huangqi decoction and entecavir
3:placebo and entecavir

Sponsors

Shuguang Hospital affiliated Shanghai University of TCM
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Previous history of hepatitis B or HBsAg positive is greater than 6 months; aged 18-65 years old male and female; clinically diagnosed as hepatitis B patients with cirrhosis: imaging is consistent with liver cirrhosis characteristics (ultrasound B showed liver shrinkage, surface unevenness, substance Uneven echo, nodular, widened in the portal vein or splenic vein, etc.; Liver transient ultrasound examination, liver hardness value = 14 kPa. Child-Pugh classification of liver function grade B, total score 7-9, ALT<2×ULN, TBIL<2×ULN (standard upper limit); viral load detection: HBeAg positive, HBV-DNA<1×10^5 copies/ml, HBeAg-negative, HBV-DNA<1×10^4 copies/ml; may have portal hypertension, such as mild esophageal varices, small amount of ascites, hepatic encephalopathy, but no upper gastrointestinal bleeding; tha subject or his guardian agree Participate in randomized controlled trials and sign informed consent.

Exclusion criteria

Exclusion criteria: Alcoholic drug-induced hereditary, immunological, other viral or non-viral chronic hepatitis patients; diagnosed as chronic hepatitis B with severe or severe hepatitis; cirrhosis with Child-Pugh score 100µg/L; patients with severe cardiovascular, pulmonary, renal, endocrine, neurological and hematological diseases; immunodeficient patients: such as HIV infection or near Take immunosuppressive agents or glucocorticoids (such as cyclosporin, azathioprine, adrenocortical hormone), or chemotherapeutic agents (such as cyclophosphamide, methotrexate, cancer chemotherapy) and radiotherapy within 3 months; Organ transplantation (such as liver, kidney, lung, heart) or bone marrow transplantation and stem cell transplantation; pregnant women, pregnant or lactating women; known to be allergic or intolerant to any component of the test drug; mental illness, alcohol abuse history, Drug or other substance abusers; those who have participated in any drug trial in the past 1 month. Other circumstances that the investigator believes are not suitable for inclusion.

Design outcomes

Primary

MeasureTime frame
liver function;kidney function;blood test;urine test;

Countries

China

Contacts

Public ContactZhang Hua

Shuguang Hospital affiliated with Shanghai University of TCM

lnutcmzh@126.com+86 021-20256520

Outcome results

None listed

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