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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025397
Receipt No. R000029236
Scientific Title Effect of Salacia oblonga extract on blood pressure in high-normal blood pressure or grade I hypertension subjects: a dose-comparison trial
Date of disclosure of the study information 2016/12/27
Last modified on 2017/08/09

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Basic information
Public title Effect of Salacia oblonga extract on blood pressure in high-normal blood pressure or grade I hypertension subjects: a dose-comparison trial
Acronym Effect of Salacia oblonga extract on blood pressure in high-normal blood pressure or grade I hypertension subjects: a dose-comparison trial
Scientific Title Effect of Salacia oblonga extract on blood pressure in high-normal blood pressure or grade I hypertension subjects: a dose-comparison trial
Scientific Title:Acronym Effect of Salacia oblonga extract on blood pressure in high-normal blood pressure or grade I hypertension subjects: a dose-comparison trial
Region
Japan

Condition
Condition Healthy volunteers
Hypertension
Classification by specialty
Cardiology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate blood pressure-lowering effect of Salacia oblonga extract comparing two doses in high-normal blood pressure or grade I hypertension subjects.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes 3-week change in home blood pressure
Key secondary outcomes 3-week change in ankle-brachial index (ABI) and office blood pressure

Base
Study type Interventional

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

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Subjects receive 6 tablets/day (2 tablets/time) containing a total of 180 mg of Salacia oblonga extract for 3 weeks.
Interventions/Control_2 Subjects receive 6 tablets/day (2 tablets/time) containing a total of 540 mg of Salacia oblonga extract for 3 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
70 years-old >=
Gender Male and Female
Key inclusion criteria 1) Diagnosed as high-normal blood pressure or grade I hypertension through health checks twice or more in three years
2) With habit of eating 3 meals a day
Key exclusion criteria 1) Taking antihypertensive
2) Taking medicines for chronic disease other than antihypertensive
3) Taking functional food that may affect the trial
4) Participation in any clinical trial within 90 days of the commencement of the trial
5) In pregnancy or nursing a child
6) Judged as ineligible by clinical investigators
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Fumiko Higashikawa
Organization Hiroshima University, Institute of Biomedical & Health Sciences
Division name Project Research Center for Clinical Trial and Preventive Medicine
Zip code
Address Kasumi 1-2-3, Minami-ku, Hiroshima 734-8551, JAPAN
TEL 082-257-1533
Email fumiko@hiroshima-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Fumiko Higashikawa
Organization Hiroshima University, Institute of Biomedical & Health Sciences
Division name Project Research Center for Clinical Trial and Preventive Medicine
Zip code
Address Kasumi 1-2-3, Minami-ku, Hiroshima 734-8551, JAPAN
TEL 082-257-1533
Homepage URL
Email fumiko@hiroshima-u.ac.jp

Sponsor
Institute Hiroshima University
Institute
Department

Funding Source
Organization TAKAMA Co., Ltd.
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 広島大学病院(広島県)

Other administrative information
Date of disclosure of the study information
2016 Year 12 Month 27 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
2016 Year 12 Month 22 Day
Date of IRB
Anticipated trial start date
2017 Year 02 Month 10 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
2016 Year 12 Month 26 Day
Last modified on
2017 Year 08 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029236

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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