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

June 24, 2015 updated by: University of Virginia
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Persons infected with hepatitis C virus (HCV) suffer from multiple symptoms caused by both the disease and the current conventional treatment (peginterferon alfa and ribavirin) if they can tolerate the treatment or have no contraindications to taking it. Most HCV-infected individuals eventually develop chronic liver disease that may progress to complications such as hepatocellular carcinoma, hepatic decompensation, and cirrhosis. What is not known is whether or not modulation of the HCV disease using the standardized herbal formulation 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 times a day, over 12 weeks might reduce or prevent the prevalence and severity of liver deterioration and symptoms. Thus, the objectives of this project are to: (a) demonstrate quantitatively in a sample of persons infected with HCV expected SST treatment-driven changes in serum levels of liver enzymes, viral load, and CD4+ and CD8+ T-cell counts by longitudinal statistical modeling, and to correlate these to the severity of individual symptoms, liver enzyme levels, and CD4+ and CD8+ T-cells as measured at screening, 4, 8, and 12 weeks; (b) examine in vitro the response of a line of HCV-infected cells to the standardized herbal formulation; and (c) assess the mechanism by which the herbal formulation may affect the HCV-infected cells in vitro. Taken together, the clinical and laboratory components of the study should provide a strong test of our primary hypothesis that compared to placebo a standardized combined herbal formulation, SST, will reduce viral load, liver enzymes, and improve CD4+ and CD8+ T-cell counts in persons infected with HCV who did not respond or have relapsed after peginterferon alfa and ribavirin or in those for whom this conventional therapy is contraindicated. Our long-term objectives are to identify the basic mechanisms underlying chronic HCV infection-related cytokines and immune mediators and to provide a rationale for mechanism-driven SST disease treatment. Confirming the effect of SST in chronic HCV infection will create a foundation for a potentially supportive approach to managing HCV disease-related and treatment-related symptoms. Ability to reduce liver damage or even prevent the side effects of conventional therapy through the use of a standardized herbal formula, SST, would be of potential benefit to thousands of persons infected with HCV by providing an herbal treatment when the current conventional therapy is not effective or is contraindicated.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Absolute Neutrophil Count (ANC) <1.5 k/dL
  • serum creatinine >1.5 mg/dL
  • alanine transaminase (ALT) > 10 x baseline
  • Hypertension (SBP > 140 or DBP >90)
  • Hypokalemia (K < 3.5)
  • Liver biopsy results that reveal stage 4 fibrosis (cirrhosis)
  • Cirrhosis or at risk for developing hepatocellular carcinoma as evidenced by an elevated AFP test at screening.
  • Undergone transplant of any kind and/or taking corticosteroids or other immunosuppressive therapy (or have taken immunosuppressive therapy within the previous 6 months)
  • Consuming alcohol.
  • Hypersensitivity to any of the 7 components of SST.
  • Taking over-the counter products that could potentially interact with the components of SST.
  • Have participated in another investigational drug study within the past 60 days.
  • Taking anthraquinone drugs or herbs containing anthraquinone
  • In a methadone maintenance program.
  • Using recreational drugs.
  • Pregnant, breastfeeding, or unwillingness to use an approved form of birth control for women of childbearing potential.
  • Unable to understand the consent process or study-related questions due to language barriers, cognitive impairment, or other reasons.
  • Weigh more than 275 pounds, which could complicate liver biopsy procedures.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: 1
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)
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
Placebo Comparator: 2
placebo capsules that look and smell identical to the active Sho-saiko-to (SST) capsules
Other: placebo capsule identical to the active herbal formula
3 placebo capsules 2 x day

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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.
At 4, 8, 12, 16 weeks.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Improvement in symptoms of depression/sadness, fear related to HCV disease progression, uncertainty, and hopelessness over time
Time Frame: At baseline and 12 weeks.
At baseline and 12 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Virginia

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ann G Taylor, EdD, University of Virginia
  • Study Director: Abdullah M Al-Osaimi, MD, University of Virginia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 3, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 3, 2008

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 11, 2008

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 25, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 24, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AGT006
  • IRB-HSR #12957

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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