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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000016456
Receipt No. R000018767
Scientific Title A clinical study for evaluating the efficacy and safety of long-term consumption of the honey vinegar beverage on lowering blood pressure in the subjects with high normal blood pressure or grade 1 hypertension
Date of disclosure of the study information 2016/08/31
Last modified on 2015/02/02

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Basic information
Public title A clinical study for evaluating the efficacy and safety of long-term consumption of the honey vinegar beverage on lowering blood pressure in the subjects with high normal blood pressure or grade 1 hypertension
Acronym A clinical study for evaluating the efficacy and safety of long-term consumption of the honey vinegar beverage on lowering blood pressure
Scientific Title A clinical study for evaluating the efficacy and safety of long-term consumption of the honey vinegar beverage on lowering blood pressure in the subjects with high normal blood pressure or grade 1 hypertension
Scientific Title:Acronym A clinical study for evaluating the efficacy and safety of long-term consumption of the honey vinegar beverage on lowering blood pressure
Region
Japan

Condition
Condition hypertension
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the blood pressure lowering effects and safety of long-term consumption of the honey vinegar beverage in the subjects with high normal blood pressure or grade 1 hypertension
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Systolic blood pressure and diastolic blood pressure
Key secondary outcomes Blood chemistry, hematology, urinalysis, body weight, pulse rate, medical interview

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification YES
Dynamic allocation NO
Institution consideration
Blocking NO
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Consumption of the honey vinegar beverage for 12 weeks
Interventions/Control_2 Consumption of control beverage without honey vinegar for 12 weeks
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
65 years-old >=
Gender Male and Female
Key inclusion criteria 1) Subjects aged from 20 to 65 years old
2) Subjects with high normal blood pressure (systolic BP from 130 to 139/ or diastolic BP from 85 to 89 mm Hg) or grade 1 hypertension (systolic BP from 140 to 159/ or diastolic BP from 90 to 99 mm Hg)
3) Subjects who have a briefing of the content of the present study, fully understanding and agreeing to its objective and being able to personally sign a written informed consent
Key exclusion criteria 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
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Osami Kajimoto
Organization Osaka City University Graduate School of Medicine
Division name Department of Medical Science on Fatigue
Zip code
Address 1-4-3 Asahimachi, Abeno-ku, Osaka
TEL 06-6645-6171
Email kajimoto@med.osaka-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tomohiro Sugino
Organization Soiken Inc.
Division name R&D Division
Zip code
Address Senri Life Science Center 13F, 1-4-2,Shinsenri-higashimachi,Toyonaka,Osaka
TEL 06-6871-8888
Homepage URL
Email sugino@soiken.com

Sponsor
Institute Soiken Inc.
Institute
Department

Funding Source
Organization Yamada Bee Company, Inc.
Organization
Division
Category of Funding Organization Profit 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 ふくだ内科クリニック(大阪府)

Other administrative information
Date of disclosure of the study information
2016 Year 08 Month 31 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 Preinitiation
Date of protocol fixation
2014 Year 11 Month 15 Day
Date of IRB
Anticipated trial start date
2015 Year 02 Month 07 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 02 Month 06 Day
Last modified on
2015 Year 02 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018767

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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