NCT00633230

Brief Summary

The purpose of this study is to (1) determine the effects of the herbal formula Sho-saiko-to (SST) compared to placebo in treating hepatitis C virus (HCV) in persons who have not responded to the current conventional therapy (peginterferon alfa and ribavirin) or who have relapsed or in those for whom conventional therapy is contraindicated; (2) determine the influence that SST will have on participant reports of depression/sadness, fear and uncertainty related to the HCV disease progression, and renewal of hope in these individuals; and (3) collect preliminary data needed to examine feasibility, patient acceptance, and any potential limitations of the study.

Trial Health

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 3, 2008

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 11, 2008

Completed
Last Updated

June 25, 2015

Status Verified

June 1, 2015

First QC Date

March 3, 2008

Last Update Submit

June 24, 2015

Conditions

Hepatitis C Virus

Keywords

hepatitis C viruscomplementary and alternative medicinepeginterferon alfa and ribavirin

Outcome Measures

Primary Outcomes (1)

  • Reduction in HCV viral load, improvement in liver enzymes (ALT and AST), improvement in CD4+ and CD8+ T-cell counts.

    At 4, 8, 12, 16 weeks.

Secondary Outcomes (1)

  • Improvement in symptoms of depression/sadness, fear related to HCV disease progression, uncertainty, and hopelessness over time

    At baseline and 12 weeks.

Study Arms (2)

1

ACTIVE COMPARATOR

standardized herbal formula, Sho-saiko-to (SST): 3 capsules containing 700 mg of the SST herbal extract/capsule and 28 mg of the excipients, magnesium stearate and silicon dioxide/capsule 2 x day

Drug: standardized herbal formula, Sho-saiko-to (SST)

2

PLACEBO COMPARATOR

placebo capsules that look and smell identical to the active Sho-saiko-to (SST) capsules

Other: placebo capsule identical to the active herbal formula

Interventions

standardized herbal formula, Sho-saiko-to (SST)DRUG

3 capsules containing 700 mg of the Sho-saiko-to (SST) herbal extract/capsule and 28 mg of the excipients, magnesium stearate, and silicon dioxide/capsule 2 x day

1
placebo capsule identical to the active herbal formulaOTHER

3 placebo capsules 2 x day

2

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed with hepatitis C virus (HCV) genotype 1 with detectable HCV RNA \>2000IU/mL at baseline assessment.
  • Have relapsed after the standard care peginterferon alfa and ribavirin, or did not respond, or standard care peginterferon alfa and ribavirin contraindicated.
  • Age 18 to 65 years
  • Gender: male or female
  • If female of childbearing potential (uterus has not been removed), willingness to use an approved form of birth control with male sexual partners through entire study and for 3 months after study completion
  • Chest x-ray negative for pulmonary disease within 6 months of enrollment

You may not qualify if:

  • Age \< 18 or \> 65 years.
  • Currently on peginterferon alfa and ribavirin therapy, or have been on this therapy within the past 6 months.
  • Currently taking monoamine oxidase inhibitors (MAOIs) for depression or have a serious mental illness.
  • Diagnosed with cardiac disease, including severe heart failure, arrhythmia; significant kidney disease; asthma or other obstructive or restrictive pulmonary disease, interstitial pneumonitis and/or hypoxemia, leading to difficulty breathing or shortness of breath; immune-mediated disease (e.g., rheumatoid arthritis, vasculitis).
  • Pulmonary function resulting in Forced Expiratory Volume (FEV1) at least 80% predicted.
  • Confirmed diagnosis of TB.
  • Infected with HIV, hepatitis A, B, D, E, or other viral blood infection (e.g., EBV, CMV)
  • Taking anticoagulant therapy or have had anticoagulants within 30 days of enrollment
  • Have taken antiviral medications within past 30 days
  • Laboratory tests resulting in:
  • platelet count ≤100,000/mm3
  • serum bilirubin \>1.5 g/dL
  • Prothrombin Time-International Normalized Ratio (INR) \>1.5
  • albumin \<3.4 g/dL
  • hemoglobin \<13 g/dL in men, \<12 g/dL in women
  • +18 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hepatitis C

Interventions

shosaiko-to

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Study Officials

  • Ann G Taylor, EdD

    University of Virginia

    PRINCIPAL INVESTIGATOR

  • Abdullah M Al-Osaimi, MD

    University of Virginia

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 3, 2008

First Posted

March 11, 2008

Last Updated

June 25, 2015

Record last verified: 2015-06