Yokohama Combined Treatment With Oriental Herb Randomized Efficacy On Obesity Hypertension (Y-CORE) Study

UMIN ID: UMIN000003878

Registered date:06/07/2010

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Obesity hypertension
• Date of first enrollment: 2010/07/01
• Target sample size: 200
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Combination of western medicine and oriental herbal medicine group: In addition to western anti-hypertensive therapy including diet and exercize therapy, an oriental herbal medicine Bofu-tsusho-san is started with daily dose of 2.5 g, titrated up to 7.5 g as neded, and continued for 24 weeks. Anti-hypertensive therapy is performed to achieve target blood pressure described in JSH2009.
Control western medicine group: Western anti-hypertensive therapy including diet and exercize therapy is continued for 24 weeks. Anti-hypertensive therapy is performed to achieve target blood pressure described in JSH2009.

Outcome(s)

• Primary Outcome: Ambulatory blood pressure (BP) profiles (mean BP, diurnal BP profile, base BP, BP variability) at baseline and after 3 and 6 months.
• Secondary Outcome: Body weight, BMI, abdominal circumference, glucose metabolism (FBG, HbA1c, HOMA-IR, IRI, adiponectin, resistin), lipid metabolism (T-cho, LDL-cho, HDL-cho, TG), oxidative stress (MDA-LDL-cho, pentosidine, urinary L-FABP), urinary angiotensinogen, renal function (urinary albumin excretion, urinary protein excretion, estimated GFR), blood electrolyte (sodium, potassium, chloride), baPWV, episode of cardiovascular disease, and adverse effects.

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 80years-old
• Gender: Male and Female
• Exclude criteria: Exclusion criteria; 1. Age < 20 years old or >= 80 years old. 2. Pregnant women, nursing women, or women suspected of being pregnant. 3. Secondary hypertension, maliganant hypertension, or grade III hypertension (SBP >= 180 mmHg or DBP >= 110 mmHg) 4. Hyperthyroidism. 5. History of coronary artery disease or cerebral artery disease with 6 months. 6. Judged as inappropriate for study by doctor.

Related Information

• Primary Sponsor: Department of Medical Science and Cardiorenal Medicine, Yokohama City University Graduate School of Medicine.
• Source(s) of Monetary Support: Health and Labor Sciences Research grant.