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Effects of Sho-saiko-to, a Herbal Formula, in Reducing Viral Load in Hepatitis C

NCT00633230 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2015-06-25

No results posted yet for this study

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.

Conditions

  • Hepatitis C Virus

Interventions

DRUG

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

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

OTHER

placebo capsule identical to the active herbal formula

3 placebo capsules 2 x day

Sponsors & Collaborators

  • University of Virginia

    lead OTHER

Principal Investigators

  • Ann G Taylor, EdD · University of Virginia

  • Abdullah M Al-Osaimi, MD · University of Virginia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00633230 on ClinicalTrials.gov