Obstructive sleep apnea syndrome, Hypertension, Obesity
Conditions
Interventions
Bofutsushosan 7.5g per day for 6months.
Daisaikoto 7.5g per day for 6months.
control(when the patients refused to take the medication)
Sponsors
Kyoto University,Graduate School of Medicine,Department of respiratory medicine
Eligibility
Sex/Gender
All
Inclusion criteria
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.
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in body weight | — |
Secondary
| Measure | Time frame |
|---|---|
| Blood pressure,Visceral fat accumulation | — |
Countries
Japan
Contacts
Public ContactToru Oga
Graduate School of Medicine, Kyoto University Department of Respiratory Care and Sleep Control Medicine
Outcome results
None listed