Hepatitis C VirusPhase 1NCT00633230
Effects of Sho-saiko-to, a Herbal Formula, in Reducing Viral Load in Hepatitis C
A Phase 1 study testing standardized herbal formula, Sho-saiko-to (SST) in people with Hepatitis C Virus, run by University of Virginia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hepatitis C Virus
- What is being tested?
- standardized herbal formula, Sho-saiko-to (SST)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
About this study
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.
Read the 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.
- Conditions
- Hepatitis C Virus
- Being tested
- standardized herbal formula, Sho-saiko-to (SST), placebo capsule identical to the active herbal formula
- Keywords
- hepatitis C virus, complementary and alternative medicine, peginterferon alfa and ribavirin
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
placebo capsule identical to the active herbal formulaOther
3 placebo capsules 2 x day
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: placebo capsule identical to the active herbal formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in HCV viral load, improvement in liver enzymes (ALT and AST), improvement in CD4+ and CD8+ T-cell counts.
Measured: 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
Measured: At baseline and 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2008 (estimated)
Why it stopped: No funding secured
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis C VirusStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Investigators
- Ann G Taylor, EdD, Principal investigator, University of VirginiaAbdullah M Al-Osaimi, MD, Study director, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00633230
- Sponsor's protocol ID
- AGT006
- Other IDs
- IRB-HSR #12957
- Status last verified
- Jun 2015
- First submitted
- 3 Mar 2008
- Last updated
- 25 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Sho-saiko-to, a Herbal Formula, in Reducing Viral Load in Hepatitis C
- ClinicalTrials.gov ID
- NCT00633230
- Acronym / sponsor ID
- AGT006
- Conditions
- Hepatitis C Virus
- Keywords
- hepatitis C virus, complementary and alternative medicine, peginterferon alfa and ribavirin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No funding secured
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- First posted
- 11 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: standardized herbal formula, Sho-saiko-to (SST)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 |
| 2 | Placebo comparator | Other: placebo capsule identical to the active herbal formulaplacebo capsules that look and smell identical to the active Sho-saiko-to (SST) capsules |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (33 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Drug | 1 |
| placebo capsule identical to the active herbal formula3 placebo capsules 2 x day | Other | 2 |
Primary outcome
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.
1 secondary outcome
Improvement in symptoms of depression/sadness, fear related to HCV disease progression, uncertainty, and hopelessness over time
Time frame: At baseline and 12 weeks.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ann G Taylor, EdD principal investigator
University of Virginia
Abdullah M Al-Osaimi, MD study director
University of Virginia
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing standardized herbal formula, Sho-saiko-to (SST) in people with Hepatitis C Virus, run by University of Virginia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 25 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2015.