metabolic syndrome
Conditions
Interventions
27 extract tablets of bofutsushosan manufactured by Kracie Pharmaceutical Ltd. per day, in 3 divided doses before or between meals, during 6 months
27 placebo tablets per day, in 3 divided doses befor
Sponsors
Oriental Medicine Research Center, Kitasato University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Both A and B are required A: abdominal circumference: 85 cm or over in men and 90 cm or over in women B: one or more requirements below shold be met 1.[TG: 150mg/dl or over] and/or [HDL 40mg/dl or over] 2.[systolic blood pressure: 130mmHg or over] and/or [diastorlic blood pressure: 85mmHg or over] 3.fasting blood glucose: 110mg/dl or over
Exclusion criteria
Exclusion criteria: 1.those who are taking Kampo drugs 2.those who have taken Kampo drugs in the past 4 weeks 3.those who need the treatment by conventional medicine 4.those who present significant liver or renal dysfunction 5.those who are taking the drugs affecting abdominal circumference or body weight 6.those who are taking antihyperlipidemic agents, antihypertensive agents, or antihyperglycemic agents 7.those with malignancy or heart failure which affects their general condition 8.those judged unsuitable for the trial by physician-in-charge
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| body weight after 6-month administration | — |
Secondary
| Measure | Time frame |
|---|---|
| abdominal circumference, blood pressure, HDL, LDL, TG, HbA1c, FBS, HOMA-IR, hs-CRP, CAVI, S100A12, adiponectin, TNF-alfa, and SF-36 after 6-month administration and adverse events during the test period | — |
Countries
Japan
Contacts
Public ContactHiroshi Odaguchi
Oriental Medicine Research Center, Kitasato University Center for Evidence-Based Medicine
Outcome results
None listed