UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003981 |
|---|---|
| Receipt number | 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 13:23:31 |
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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
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
Sponsor or person
Institute
Kyoto University,Graduate School of Medicine,Department of respiratory medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004773
