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Efficacy of PIENTZEHUANG Treatment on Chronic Hepatitis B

Efficacy and Safety of PIENTZEHUANG Treatment on Chronic Hepatitis B: A Multicenter, Randomized, Controlled Study

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-14005092
Enrollment
Unknown
Registered
2014-08-08
Start date
2014-08-20
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

Chronic Hepatitis B

Interventions

Sponsors

Beijing YouAn Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Gender and sex: 18 to 65 years old (including 18 and 65 years old), male or female; 2. HBsAg positive for at least 6 months; 3. Serum alanine aminotransferase (ALT) between one to five times of upper limit of normal (ULN) and serum total bilirubin less than two times of ULN; 4. Recieved no antiviral treatment in 6 months before enrolled; 5. Syndrome classification in TCM is accumulated damp-heat type or blood stagnation type; 6. Subjects or their legal representatives could understand and sign the informed consent form, communicate with researchers, and cooperate with the study plan.

Exclusion criteria

Exclusion criteria: 1. Decompensated liver cirrhosis; Primary or metastatic liver cancer; Autoimmune liver disease; Drug-induced liver disease; Alcoholic liver disease; Toxic liver damage; Non-alcoholic fatty liver disease; 2. Prothrombin activity less than 50%, blood platelet less than 50E+9/L and/or blood white blood cell less than 3.0E+9/L; 3. Alpha fetal protein greater than 200ng/ml; 4. With history of alcoholism or drug abuse; With history of gastrointestinal ulcer or asthma; With severe endocrine disease, heart disease, pulmonary disease or renal disease; With mental disease; 5. Receiving or having received other experimental drug treatment in 3 months before enrolled; 6. Pregnant woman, lactating mother or woman planning to be pregnant; 7. Unwilling to participate in this study or with other situation not suitable to participate in this study.

Design outcomes

Primary

MeasureTime frame
clinical symptoms;liver function tests;

Secondary

MeasureTime frame
HBVDNA concentration;HBsAg titer;HBeAg titer;indicators of liver fibrosis;B ultrasound;liver hardnessvalue in fibroscan;

Countries

China

Contacts

Public ContactDuan Zhong Ping
duan2517@163.com+86 010-83997007

Outcome results

None listed

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