A clinical study for evaluating the safety of excessive consumption of the honey vinegar beverage
- Conditions
- hypertension
- Registration Number
- JPRN-UMIN000016586
- Lead Sponsor
- Soiken Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 40
Not provided
1) Subjects who need an urgent anti-hypertensive treatment 2) Subjects who have a symptom of cerebrovascular diseases 3) Heart failure patients or subjects who have a history of myocardial infarction 4) Subjects who have an atrial fibrillation or a severe arrhythmia 5) Subjects who have a severe renal dysfunction (serum creatinine >=2 mg/dl) 6) Subjects who have severe hepatic, cardiovascular, respiratory disease, endocrine or metabolic disorders 7) Subjects who have a history of the hypersensitivity or an allergy for test foods in this study 8) Subjects who have a secondary hypertension 9) Subjects who regularly take any anti-hypertensive drug or FOSHU for improving hypertension 10) For female: Subjects with pregnant or breast feeding , or those who have a plan to be pregnant during the study period 11) Subject having blood sample of 200 ml or more taken (e.g., donated blood) within 1 month, or 400 ml or more within 3 months prior to the start of the present study 12) Subject who took part in another clinical study within 3 months prior to the start of the present study or who is currently taking part in another clinical study 13) Subject deemed unsuitable by the investigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method