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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000003878
Receipt No. R000004531
Scientific Title Yokohama Combined Treatment With Oriental Herb Randomized Efficacy On Obesity Hypertension (Y-CORE) Study
Date of disclosure of the study information 2010/07/06
Last modified on 2015/09/19

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Basic information
Public title Yokohama Combined Treatment With Oriental Herb Randomized Efficacy On Obesity Hypertension (Y-CORE) Study
Acronym Yokohama Combined Treatment With Oriental Herb Randomized Efficacy On Obesity Hypertension (Y-CORE) Study
Scientific Title Yokohama Combined Treatment With Oriental Herb Randomized Efficacy On Obesity Hypertension (Y-CORE) Study
Scientific Title:Acronym Yokohama Combined Treatment With Oriental Herb Randomized Efficacy On Obesity Hypertension (Y-CORE) Study
Region
Japan

Condition
Condition Obesity hypertension
Classification by specialty
Medicine in general Cardiology Endocrinology and Metabolism
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 In this study we will examine putative additional beneficial effects of an anti-obesity oriental herb medicine, bofutsushosan, when combined with standard western therapeutic strategy, on ambulatory blood pressure profile, glucose and lipid metabolism, and oxidative stress in patients with obesity hypertension.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes Ambulatory blood pressure (BP) profiles (mean BP, diurnal BP profile, base BP, BP variability) at baseline and after 3 and 6 months.
Key secondary outcomes 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.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 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.
Interventions/Control_2 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.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria Essential hypertensive (male and female) patients with obesity under anti-hypertensive treatments including diet and exercise therapy for more than 4 weeks.
Other selection criteria;
1. Age >=20 years old, but < 80 years old.
2. BMI >= 25 kg/m2.
3. Written informed consent obtained.
Key exclusion 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.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name KOUICHI TAMURA
Organization Yokohama City University Hospital
Division name Department of Cardiorenal Medicine
Zip code
Address 3-9 Fukuura, kanazawa-ku, Yokohama, Kanagawa 236-0004, JAPAN
TEL 045-787-2800
Email tamukou@med.yokohama-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name KOUICHI TAMURA
Organization Yokohama City University Graduate School of Medicine
Division name Department of Medical Science and Cardiorenal Medicine
Zip code
Address 3-9 Fukuura, kanazawa-ku, Yokohama, Kanagawa 236-0004, JAPAN
TEL 045-787-2635
Homepage URL http://www.yokohama-medicine.org/
Email tamukou@med.yokohama-cu.ac.jp

Sponsor
Institute Department of Medical Science and Cardiorenal Medicine, Yokohama City University Graduate School of Medicine.
Institute
Department

Funding Source
Organization Health and Labor Sciences Research grant.
Organization
Division
Category of Funding Organization
Nationality of Funding Organization JAPAN

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 横浜市立大学附属病院(神奈川県),横浜市立大学市民総合医療センター(神奈川県),藤沢市民病院(神奈川県),横浜親善病院(神奈川県),国立病院機構相模原病院(神奈川県),横浜南共済病院(神奈川県),大和市立病院(神奈川県),宮川内科小児科医院(神奈川県).

Other administrative information
Date of disclosure of the study information
2010 Year 07 Month 06 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Main results already published
Date of protocol fixation
2010 Year 07 Month 02 Day
Date of IRB
Anticipated trial start date
2010 Year 07 Month 01 Day
Last follow-up date
2015 Year 06 Month 01 Day
Date of closure to data entry
2016 Year 06 Month 01 Day
Date trial data considered complete
2017 Year 06 Month 01 Day
Date analysis concluded
2018 Year 06 Month 01 Day

Other
Other related information

Management information
Registered date
2010 Year 07 Month 06 Day
Last modified on
2015 Year 09 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004531

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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