UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003878 |
|---|---|
| Receipt number | 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 10:00:42 |
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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
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/
tamukou@med.yokohama-cu.ac.jp
Sponsor or person
Institute
Department of Medical Science and Cardiorenal Medicine, Yokohama City University Graduate School of Medicine.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004531
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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