The efficacy and safety of Kampo (Japanese herbal) medicine, bofutsushosan, on matabolic syndrome -a randomized, double-blind, placebo-controlled trial
Not Applicable
Completed
- Conditions
- metabolic syndrome
- Registration Number
- JPRN-UMIN000003528
- Lead Sponsor
- Oriental Medicine Research Center, Kitasato University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 180
Inclusion Criteria
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method body weight after 6-month administration
- Secondary Outcome Measures
Name Time Method 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