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A Clinical Study of theTraditional Chinese Formula of Bu Shen Qu Xie on Chronic Hepatitis B

A Clinical Study of theTraditional Chinese Formula of Bu Shen Qu Xie on Chronic Hepatitis B

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-12002190
Enrollment
Unknown
Registered
2012-03-14
Start date
2012-05-01
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

Chronic Hepatitis B

Interventions

Group A:Diwuyanggan Granules orally taken twice daily for 48 weeks
Entecavir 0.5mg orally taken once daily for 48 weeks.
Group B:Placebo Granules orally taken twice daily for 48 weeks
Entecavir 0.5mg orally taken once daily for 48 weeks

Sponsors

Hubei Provincial Traditional Chinese Medical Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Diagnosed as HBeAg-negative Chronic Hepatitis B, have not been treated with anti-viral treatment in western medicine in six months; 2. ALT >= 2*ULN or 1*ULN=4, HBVDNA>=1*10^4 copies/ml (Equivalent to 2000 IU/ ml); 3. Patients who have not been treated with Chinese and western medicine to reduce transaminase in the latest month; 4. Male and female aged 18 to 65 years old; 5. To be able to and willing to provide signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Male and female aged below 18 or above 65 years old; 2. Exclude the same time or overlap with other types of viral hepatitis infection; 3. Confirmed as caused by drug intoxication, alcohol poisoning, hepatitis and autoimmune hepatitis; 4. Patients who have been diagnosed with severe hepatitis, severe hepatitis / liver failure, cirrhosis, liver cancer and have serious primary disease in cardiovascular and cerebrovascular, kidney, lung, endocrine system, hematopoietic system of severe primary disease and patients with mental disease; 5. Pregnant or lactating women; 6. allergic to drug; 7. Patients who have been used interferon antiviral within six months.

Design outcomes

Primary

MeasureTime frame
HBVDNA;HBV antigen and antibody complete set test;Liver morphological change;Liver Biopsy;Liver Function index;Quality of life scale for Chronic Hepatitis;

Countries

China

Contacts

Public ContactGuoguang Sheng
sguo53@yahoo.com.cn+86 13317199890

Outcome results

None listed

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