Efficacy of the combination therapy of Juzen-taiho-to (TJ-48) and ursodeoxycholic acid (UDCA) in HCV-associated chronic liver disease: a prospective, randomized, cross-over study
Phase 2
- Conditions
- HCV-associated chronic liver disease
- Registration Number
- JPRN-UMIN000011948
- Lead Sponsor
- Yokohama City University Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
Not provided
Exclusion Criteria
1) Patient who received interferon treatment in previous 24 weeks 2) Patients who received medical Kampo preparations in previous 4 weeks 3) Patients who received the so-called "liver function improving drug" other than UDCA 4) Patients with hepatocellular carcinoma 5)Patients with serious complications 6) Woman in pregnancy or willing to get pregnant 7) Patients who are judged as inadequate for the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Improvement of serum alanine amino transferase levels after combination therapy of TJ-48 and UDCA for 16 weeks against UDCA alone therapy
- Secondary Outcome Measures
Name Time Method 1) Ratio of the patients who improved more than 25% in serum alanine amino transferase levels 2) Changes of liver function tests during the treatment 3) Adverse events