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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000008088
Receipt No. R000009522
Scientific Title A randomized control trial of mushroom ice and mushroom extract for hypertension.
Date of disclosure of the study information 2012/06/02
Last modified on 2013/01/10

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Basic information
Public title A randomized control trial of mushroom ice and mushroom extract for hypertension.
Acronym RCT of mushroom ice and mushroom extract for hypertension.
Scientific Title A randomized control trial of mushroom ice and mushroom extract for hypertension.
Scientific Title:Acronym RCT of mushroom ice and mushroom extract for hypertension.
Region
Japan

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

Objectives
Narrative objectives1 To evaluate the effectiveness of processed Flammulina velutipes (Enoki ice) for hypertension
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Change in SBP, DBP after 12 weeks
Key secondary outcomes Changes in serum lipid test values

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 4
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Enoki Ice 3 block/day
Interventions/Control_2 Enokitake extract 6g/day
Interventions/Control_3 Pracebo 6g/day
Interventions/Control_4 Enoki Ice 0 block/day
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
18 years-old <=
Age-upper limit
75 years-old >
Gender Male and Female
Key inclusion criteria The persons with systolic blood pressure 140-159mmHg or diastolic blood pressure 90-99mmHg with untreatment.
Key exclusion criteria 1) The patients with medication.
2) The women who are or may be pregnant.
3) The patients with 1 or 2 risk factor or metabolic syndrome except diabetes (Phase 2 risk of JSH2009).
4) The patients with 3 or more risk factor of Diabetes, CKD, organopathy/ Cardiovascular disease(Phase 3 risk of JSH2009).
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Fumio Eguchi
Organization Tokyo University of Agriculture
Division name Department of Forest Science, Faculty of Regional Environment Science
Zip code
Address 1-1-1 Sakuragaoka, Setagaya-ku, Tokyo, JAPAN
TEL 03-5477-2279
Email

Public contact
Name of contact person
1st name
Middle name
Last name Fumio Eguchi
Organization Tokyo University of Agriculture
Division name Department of Forest Science, Faculty of Regional Environment Science
Zip code
Address 1-1-1 Sakuragaoka, Setagaya-ku, Tokyo, JAPAN
TEL 03-5477-2279
Homepage URL
Email

Sponsor
Institute Tokyo University of Agriculture
Institute
Department

Funding Source
Organization JA Nakano-shi
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor St. Marianna University School of Medicine
Hokushin General Hospital
Takasaki University of Health and Welfare
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
2012 Year 06 Month 02 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 No longer recruiting
Date of protocol fixation
2012 Year 05 Month 15 Day
Date of IRB
Anticipated trial start date
2012 Year 07 Month 01 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
2012 Year 06 Month 02 Day
Last modified on
2013 Year 01 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009522

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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