SST Clinical Trial Information (from clinicaltrials.gov):

SHO-SAIKO-TO for Patients With Chronic Hepatitis C: A Phase II Study (Memorial Sloan-Kettering Cancer Center)

Study Design: Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study

Official Title: SHO-SAIKO-TO for Patients With Chronic Hepatitis C Who Are Intolerant to or Have Contraindication to Interferon-Based Therapy: A Phase II Study

Primary Outcome Measures: To determine the effects of Sho-saiko-to on hepatic injury in patients with chronic hepatitis C who are intolerant or have a specific contraindication to interferon-based therapy. [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures: To determine the effects of SST therapy on liver function and viral load [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 45

Study Start Date: October 2002

Estimated Study Completion Date: October 2009

Estimated Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)

Sho-Saiko-To Following Removal of Liver Cancer By Embolization in Treating Patients With Liver Cancer That Cannot Be Surgically Removed (Memorial Sloan-Kettering Cancer Center)

Official Title: Sho-Saiko-To After Ablation for Non-Resectable Hepatocellular Carcinoma (HCC): A Phase II Trial With Historical Control

Study Start Date: January 2001

OBJECTIVES: Compare the overall survival of patients with unresectable hepatocellular carcinoma treated with Sho-saiko-to after ablation therapy with embolization vs historical control patients.

Compare the liver function and alpha fetoprotein levels in patients treated with this drug vs historical control patients.

Compare the intervention-free survival in patients treated with this drug vs historical control patients.

OUTLINE: Beginning within 1 week after the first course of ablation therapy with embolization, patients receive oral Sho-saiko-to three times daily. Treatment with Sho-saiko-to continues in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 78 patients will be accrued for this study within 18-24 months.

Effects of Sho-Saiko-to, a Herbal Formula, in Reducing Viral Load in Hepatitis C (University of Virginia, not yet open)

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study

Official Title: Effects of Sho-Saiko-to, a Herbal Formula, in Reducing Viral Load in Hepatitis C

Primary Outcome Measures: Reduction in HCV viral load, improvement in liver enzymes (ALT and AST), improvement in CD4+ and CD8+ T-cell counts. [ Time Frame: At 4, 8, 12, 16 weeks. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures: Improvement in symptoms of depression/sadness, fear related to HCV disease progression, uncertainty, and hopelessness over time [ Time Frame: At baseline and 12 weeks. ] [ Designated as safety issue: No ]

Estimated Enrollment: 40

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