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Study of integrated Chinese medicine with conventional medicine in the treatment of chronic hepatitis B

Study of integrated Chinese medicine with conventional medicine in the treatment of chronic hepatitis B

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-12002784
Enrollment
Unknown
Registered
2012-11-30
Start date
2012-12-03
Completion date
Unknown
Last updated
2020-03-30

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

Conditions

Chronic hepatitis with positive HBeAg

Interventions

Expirement group:Traditional Chinese medicine, integrated traditional Chinese and Western medicine treatment

Sponsors

Dongzhimen Hospital, Beijing University of TCM
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Match the diagnositc standard of HBeAg positive hepatitis B; 2. Aged 18-65 years; 3. Positive HBV-DNA of serum test; 4. Liver function and HBeAg or live pathology match of the following situations: (1) ALT 2*ULN to 3*ULN and HBeAg 50-100 S/CO (equal to 11.63-24.26 PEIU/ml); (2) ALT 2*ULN to 3*ULN and HBeAg700-1250 S/CO (equal to 190.82-352.81 PEIU/ml) and the cases should not less than 60% of total number of participants; (3) ALT 3*ULN to 5*ULN and HBeAg=4 or atory necrosis>=G2, or rate of liver fibrosis >=S2(5)TBIL=2*ULN), TCM signs standard [C]. The Conference Book of the Fourth International Liver Diseases Conference of World TCM Sociate and Mainland-Taiwan TCM Liver Diseases Conference, Xiamen, 2011.291-292.

Exclusion criteria

Exclusion criteria: (1) Pregnancy or preparing to pregnance women, lactating women, man preparing to insemination; (2) Confirmed multiple infection of hepatitis virus by serum test, none virus caused chronic liver diseases such as Alcoholic liver disease, or cryptogenic hepatitis; (3) combined with cirrhosis (liver fibrosis above S4), liver cancer, hepatic encephalopathy, Water electrolyte and acid-base balance disturbance, gastrointestinal bleeding, severe compications with chronic hepatitis; (4) Severe chronic hepatitis B and chronic severe heparitics; (5) Orginal and/or Secondary cardiovascular and cerebrovascular, lung, kindney, endocrine system, nerve system and blood system diseases; (6) To be participated other clinical studies in past one month; (7) Mental disorder unable to express the own feeling; (8) Mutation of hepatitis B virus; (9) To be with drug resistance variation against Entecavir.

Design outcomes

Primary

MeasureTime frame
TCM syndrome score;Virus serological indexes: HBeAg, HBeAb;Virus nucleic acid index: HBV DNA;

Countries

China

Contacts

Public ContactYe Yongan
leadian@sina.com+86 13661312295

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 5, 2026