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A Study of the Clinical Manifestation and the Therapy of Chronic Hepatitis B Combining Traditional Chinese with Western Medicine

A Randomized clinical trial of Lingmao granules compared with Entecavir for Chronic hepatitis B

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-09000594
Enrollment
Unknown
Registered
2009-11-16
Start date
2008-12-01
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:Entecavir 0.5mg orally taken once daily for 12 months, and Lingmao Granules 1 one package orally taken twice daily for 12 months (six-month follow-up)
Group B:Entecavir 0.5mg orally taken once daily for 12 months, and Lingmao Granules 2 one package orally taken twice daily for 12 months (six-month follow-up)
Group C:Lingmao Granules 1 one package orally taken twice daily for 12 months (six-month follow-up)
Group D:Lingmao Granules 2 one package orally taken twice daily for 12 months (six-month follow-up)

Sponsors

Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Male and female aged 18 to 65 years old; 2. Diagnosed as Chronic Hepatitis B, have not been treated with anti-viral treatment in western medicine; 3. 1*ULN<=ALT<2*ULN; 4. Patients who have not been treated with Chinese and western medicine to reduce transaminase in the latest month; 5. Able and willing to provide signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Chronic Severe Hepatitis and Liver Cirrhosis; 2. Hepatitis infected with other type of hepatovirus; 3. Patients who have serious primary disease in heart, kidney, lung, endocrine system, blood, metabolism, or gastrointestinal tract; 4. Patients with mental disease; 5. Pregnant or lactating women; 6. allergic to drug.

Design outcomes

Primary

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

Countries

China

Contacts

Public ContactYueqiu Gao
gaoyueqiu@hotmail.com+86 13795388789

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 22, 2026