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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016432
Receipt No. R000018988
Scientific Title Effects of persimmon leaf tea intake on blood pressure and flow-mediated dilation levels; a dose finding study in subjects with high-normal blood pressure and mild hypertenssion
Date of disclosure of the study information 2015/02/03
Last modified on 2016/12/27

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Basic information
Public title Effects of persimmon leaf tea intake on blood pressure and flow-mediated dilation levels; a dose finding study in subjects with high-normal blood pressure and mild hypertenssion
Acronym A dose finding study on effects of persimmon leaf tea intake on blood pressure and flow-mediated dilation levels
Scientific Title Effects of persimmon leaf tea intake on blood pressure and flow-mediated dilation levels; a dose finding study in subjects with high-normal blood pressure and mild hypertenssion
Scientific Title:Acronym A dose finding study on effects of persimmon leaf tea intake on blood pressure and flow-mediated dilation levels
Region
Japan

Condition
Condition No (subjects with systolic blood plessure 130-159 mmHg and diastolic blood pressure 85-99 mmHg)
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the optimum dose and safty of persimmon leaf tea intake to improve blood pressure and flow-mediated dilation levels, the effects of three different doses, (350 ml/day extracted from 0, 4, 8g of the dried leaves, respectively), are compared for 8 weeks.
Basic objectives2 Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Chronological changes and comparison in blood pressure and flow mediated dilation levels among three different doses,(350ml/day extracted from 0, 4, 8g of the dried leaves, respectively).
Key secondary outcomes Evaluation of the optimum dose amount of persimmon leaf tea intake for the improvement.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Pracebo drink, brawn-colored water (350ml/day)
Interventions/Control_2 Persimmon leaf tea, low-dose (350ml/day extracted from 4g of the dried leaves)
Interventions/Control_3 Persimmon leaf tea, high-dose (350ml/day extracted from 8g of the dried leaves)
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
70 years-old >=
Gender Male and Female
Key inclusion criteria 1.Volunteers with high-normal blood pressure (SBP 130-139mmHg, DBP 85-89mmHg) and mild hypertenssion (SBP 140-159mmHg, DBP 90-99mmHg).
2.Volunteers being able to make self-judgment to participate in this study and giving written informed consent.
3.Volunteers having screening test results judged to be appropriate for this study by investigator.
Key exclusion criteria 1.Patients receiving treatment of hypertension.
2.SBP 160mmHg < ; DBP 100mmHg <.
3.Volunteers having severe history of the diseases (liver, kidney, heart, blood) judged to be inappropriate for this study.
4.Volunteers received gastrectomy, enterectomy, and gastro-intestinal dedeases, judged to be inappropriate for this study.
5.Volunteers rejected participating in this study by chief investigater.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kenichi Watanabe
Organization Niigata University of Pharmacy and Applied Life Sciences
Division name Laboratory of Clinical pharmacology
Zip code
Address 265-1, Higashijima, Akiha-ku, Niigata City
TEL 0250-25-5267
Email watanabe@nupals.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Niigata Bio-Research Park, Inc
Organization Niigata Bio-Research Park, Inc
Division name Business promotion division
Zip code
Address 316-2 Higashijima, Akiha-ku, Niigata, 956-0841, Japan
TEL 0250-25-1196
Homepage URL
Email goto@nbrp.co.jp

Sponsor
Institute Niigata Bio-Research Park, Inc
Institute
Department

Funding Source
Organization Niigata City Agricultural Development Research Center
Organization
Division
Category of Funding Organization Local Government
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

Other administrative information
Date of disclosure of the study information
2015 Year 02 Month 03 Day

Related information
URL releasing protocol
Publication of results Published

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
2015 Year 01 Month 28 Day
Date of IRB
Anticipated trial start date
2015 Year 02 Month 05 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 03 Day
Last modified on
2016 Year 12 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018988

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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