UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030171 |
|---|---|
| Receipt number | R000034459 |
| Scientific Title | Effects of grape seed proanthocyanidin extract on the endothelial function in patients with stage 1 hypertension |
| Date of disclosure of the study information | 2017/11/29 |
| Last modified on | 2019/12/02 09:56:12 |
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Basic information
Public title
Effects of grape seed proanthocyanidin extract on the endothelial function in patients with stage 1 hypertension
Acronym
Effects of grape seed proanthocyanidin extract on the endothelial function in patients with stage 1 hypertension
Scientific Title
Effects of grape seed proanthocyanidin extract on the endothelial function in patients with stage 1 hypertension
Scientific Title:Acronym
Effects of grape seed proanthocyanidin extract on the endothelial function in patients with stage 1 hypertension
Region
| Japan |
Condition
Condition
stage 1 hypertension
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of proanthocyanidin-rich grape seed extract on the endothelial function in patients with stage 1 hypertension
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
endothelial function after 12 weeks of treatment
Key secondary outcomes
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
Treatment
Type of intervention
| Food |
Interventions/Control_1
12-week treatment with 400 mg of proantohocyanidin
Interventions/Control_2
12-week treatment with 200 mg of proantohocyanidin
Interventions/Control_3
12-week treatment with 0 mg of proantohocyanidin
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
| 40 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
130 mmHg <= systolic pressure <140 mmHg and/or 85 mmHg <= diastolic pressure < 90 mmHg
Key exclusion criteria
patients who are being treated with antihypertensive drugs or dietary supplements proven to lower blood pressure
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Masakazu |
| Middle name | |
| Last name | Terauchi |
Organization
Tokyo Medical and Dental University
Division name
Department of Women's Health
Zip code
113-8510
Address
Yushima 1-5-45, Bunkyo, Tokyo
TEL
03-5803-4605
teragyne@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Masakazu |
| Middle name | |
| Last name | Terauchi |
Organization
Tokyo Medical and Dental University
Division name
Department of Women's Health
Zip code
113-8510
Address
Yushima 1-5-45, Bunkyo, Tokyo
TEL
03-5803-4605
Homepage URL
teragyne@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Medical and Dental University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Medical and Dental University
Address
Yushima 1-5-45, Bunkyo, Tokyo
Tel
03-3813-6111
info.bec@tmd.ac.jp
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
| 2017 | Year | 11 | Month | 29 | 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
30
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
| 2017 | Year | 11 | Month | 29 | Day |
Date of IRB
| 2017 | Year | 12 | Month | 22 | Day |
Anticipated trial start date
| 2018 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 11 | Month | 29 | Day |
Last modified on
| 2019 | Year | 12 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034459
