NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
UMIN ID: UMIN000003878

Registered date:06/07/2010

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

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedObesity hypertension
Date of first enrollment2010/07/01
Target sample size200
Countries of recruitmentJapan
Study typeInterventional
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 OutcomeAmbulatory blood pressure (BP) profiles (mean BP, diurnal BP profile, base BP, BP variability) at baseline and after 3 and 6 months.
Secondary OutcomeBody 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 minimum20years-old
Age maximum80years-old
GenderMale and Female
Include criteria
Exclude criteriaExclusion 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

Contact

public contact
Name KOUICHI TAMURA
Address 3-9 Fukuura, kanazawa-ku, Yokohama, Kanagawa 236-0004, JAPAN Japan
Telephone 045-787-2635
E-mail tamukou@med.yokohama-cu.ac.jp
Affiliation Yokohama City University Graduate School of Medicine Department of Medical Science and Cardiorenal Medicine
scientific contact
Name KOUICHI TAMURA
Address 3-9 Fukuura, kanazawa-ku, Yokohama, Kanagawa 236-0004, JAPAN Japan
Telephone 045-787-2800
E-mail tamukou@med.yokohama-cu.ac.jp
Affiliation Yokohama City University Hospital Department of Cardiorenal Medicine