Effects of Sho-saiko-to, a Herbal Formula, in Reducing Viral Load in Hepatitis C
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ClinicalTrials.gov Identifier: NCT00633230 |
Recruitment Status :
Withdrawn
(No funding secured)
First Posted : March 11, 2008
Last Update Posted : June 25, 2015
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Condition or disease | Intervention/treatment | Phase |
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Hepatitis C Virus | Drug: standardized herbal formula, Sho-saiko-to (SST) Other: placebo capsule identical to the active herbal formula | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 0 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Effects of Sho-saiko-to, a Herbal Formula, in Reducing Viral Load in Hepatitis C |

Arm | Intervention/treatment |
---|---|
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
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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 |
- 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. ]
- Improvement in symptoms of depression/sadness, fear related to HCV disease progression, uncertainty, and hopelessness over time [ Time Frame: At baseline and 12 weeks. ]

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00633230
Principal Investigator: | Ann G Taylor, EdD | University of Virginia | |
Study Director: | Abdullah M Al-Osaimi, MD | University of Virginia |
Responsible Party: | Professor of Nursing and Director of the Center for the Study of Complementary and Alternative Therapies, University of Virginia |
ClinicalTrials.gov Identifier: | NCT00633230 |
Other Study ID Numbers: |
AGT006 IRB-HSR #12957 |
First Posted: | March 11, 2008 Key Record Dates |
Last Update Posted: | June 25, 2015 |
Last Verified: | June 2015 |
hepatitis C virus complementary and alternative medicine peginterferon alfa and ribavirin |
Hepatitis A Hepatitis C Hepatitis Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases |
Infections Enterovirus Infections Picornaviridae Infections RNA Virus Infections Blood-Borne Infections Communicable Diseases Flaviviridae Infections |