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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003981
Receipt No. R000004773
Scientific Title Comparison of the efficacy between Bofutsushosan and Daisaikoto in sleep apnea patients complicated with persistent obese and hypertension
Date of disclosure of the study information 2010/08/15
Last modified on 2013/08/14

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Basic information
Public title Comparison of the efficacy between Bofutsushosan and Daisaikoto in sleep apnea patients complicated with persistent obese and hypertension
Acronym The efficacy of Japanese herbal medicines in sleep apnea patients complicated with persistent obese and hypertension
Scientific Title Comparison of the efficacy between Bofutsushosan and Daisaikoto in sleep apnea patients complicated with persistent obese and hypertension
Scientific Title:Acronym The efficacy of Japanese herbal medicines in sleep apnea patients complicated with persistent obese and hypertension
Region
Japan

Condition
Condition Obstructive sleep apnea syndrome, Hypertension, Obesity
Classification by specialty
Medicine in general Cardiology Pneumology
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We will evaluate the efficacy of two Japanese herbal medicines, Bofutsushosan and Daisaikoto, in patients with sleep apnea syndrome. The subjects are obstructive sleep apnea patients complicated with persistent obesity and hypertension despite of treatment with continuous positive airway pressure (CPAP) or oral appliance.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Change in body weight
Key secondary outcomes Blood pressure,Visceral fat accumulation

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Bofutsushosan 7.5g per day for 6months.
Interventions/Control_2 Daisaikoto 7.5g per day for 6months.
Interventions/Control_3 control(when the patients refused to take the medication)
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

Not applicable
Gender Male and Female
Key inclusion criteria 1.Persistent obesity and hypertension despite of 6 months of continuous positive airway pressure(CPAP) treatment for obstructive sleep apnea(OSA).
2.Obesity is defined as body mass index(BMI)>= 25kg/m2.
3.Hypertension is defined as systolic blood pressure(BP)>=130mmHg or diastolic BP>=80mmHg in more than twice determination.
4.OSA is defined as 1)sleepiness, apnea hypopnea index (AHI)>=5 and more than half of apnea is obstructive 2)AHI>=15 with or without OSA related symptoms. AHI is determined with polysomnography.
5.Undergoing appropriate nutrition and exercise therapy.
6.Patients using oral appliance will not be randomized. They will be instructed to start Bofutsushosan only.
Key exclusion criteria 1.Acute infectious diseases or malignant diseases
2.New onset of cerebrovascular infarctions or myocardial infarctions within 6 months
3.Interventions for coronary arteries within 6 months
4.Admission due to angina pectoris or heart diseases within 6 months
5.Severe heart failure (NYHA class 3 or 4) or severe arrythmia
6.Systolic BP>=160mmHg or Diastolic BP >=100mg. (We should try other usual antihypertensive drugs rather than chinese herbal medicines)
7.Allergic for Bofutsushosan or Daisaikoto
8.Taking other herbal medicines
9.Severe liver failiure or renal failure(including patiens undergoing dailysis)
9.Interstitial pneumonitis
10.Undergoing interferon treatment for hepatitis
11.Pregnancy
12.Judged as inappropriate by attending physicians
Target sample size 152

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuo Chin
Organization Graduate School of Medicine, Kyoto University
Division name Department of Respiratory Care and Sleep Control Medicine
Zip code
Address Shogoin 54, Kawahara-cho, Sakyo-ku,Kyoto,Japan
TEL 075-751-3852
Email

Public contact
Name of contact person
1st name
Middle name
Last name Toru Oga
Organization Graduate School of Medicine, Kyoto University
Division name Department of Respiratory Care and Sleep Control Medicine
Zip code
Address Shogoin 54, Kawahara-cho, Sakyo-ku,Kyoto,Japan
TEL 075-751-3852
Homepage URL
Email

Sponsor
Institute Kyoto University,Graduate School of Medicine,Department of respiratory medicine
Institute
Department

Funding Source
Organization Japanese Ministry of Health, Labour and Welfare,Grants-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

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 京都大学医学部附属病院(京都府)、岩手医科大学附属病院(岩手県)、筑波大学医学部附属病院(茨城県)、財団法人神経研究所(東京都)、千葉大学医学部附属病院(千葉県)、日本大学医学部附属病院(東京都)、愛知医科大学附属病院(愛知県)、藤田保健衛生大学医学部附属病院(愛知県)、滋賀医科大学附属病院(滋賀県)、奈良県立医科大学附属病院(奈良県)、国立病院機構京都医療センター(京都府)、霧ヶ丘つだ病院(福岡県)

Other administrative information
Date of disclosure of the study information
2010 Year 08 Month 15 Day

Related information
URL releasing protocol
Publication of results Unpublished

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 Completed
Date of protocol fixation
2010 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date
2010 Year 08 Month 01 Day
Last follow-up date
2013 Year 08 Month 01 Day
Date of closure to data entry
2014 Year 02 Month 01 Day
Date trial data considered complete
2014 Year 03 Month 01 Day
Date analysis concluded
2014 Year 06 Month 01 Day

Other
Other related information

Management information
Registered date
2010 Year 08 Month 02 Day
Last modified on
2013 Year 08 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004773

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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