Efficacy and Safety Morus Alba L. Extract on Improvement of Blood Flow
NCT ID: NCT03807570
Last Updated: 2020-05-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
100 participants
INTERVENTIONAL
2018-11-12
2021-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Morus Alba L. extract
Morus Alba L. extract 30 ml/day for 12 weeks
Morus Alba L. Extract
Morus Alba L. Extract 30 ml/day for 12 weeks.
Placebo
Placebo 30 ml/day for 12 weeks
Placebo
Placebo 30 ml/day for 12 weeks.
Interventions
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Morus Alba L. Extract
Morus Alba L. Extract 30 ml/day for 12 weeks.
Placebo
Placebo 30 ml/day for 12 weeks.
Eligibility Criteria
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Inclusion Criteria
* Those with a fasting LDL-cholesterol of 130\~159 mg/dL
* Those with a fasting blood sugar of 100\~125 mg/dL
* Those with a SBP of 120\~139 mmHg
* Those with a BMI of 25\~29.9 kg/m\^2
* Waist Hip Ratio (WHR) is 0.9 or more for males and 0.85 or more for females
Exclusion Criteria
* The platelet count is less than 100,000/μL or more than 500,000/μL
* The Hematocrit is less than 25%
* BMI is less than 18.5kg/m\^2 or greater than 30kg/m\^2
* Those with clinically significant severe cardiovascular, endocrine, immune, respiratory, liver, biliary, renal and urinary tract, neuropsychiatry, musculoskeletal, inflammatory and hematologic and gastrointestinal disorders
* Those with a history of clinically significant hypersensitivity to mulberry
* Those who have been taking platelet function, blood circulation improvement and hyperlipidemia related medicines, health functional food or herbal medicine continuously for more than 7 days within one month before screening
* Those who have received antipsychotic medication within 2 months before screening
* Those who participated in other clinical trials within 3 months before screening
* Women receiving hormone replacement therapy
* Laboratory test by show the following results
* AST, ALT \> Reference range 3 times upper limit
* Serum Creatinine \> 2.0 mg/dL
* Pregnancy or breast feeding
* Those who doesn't accept the implementation of appropriate contraception of a childbearing woman
* Principal Investigator judged inappropriate for participation in study because of Laboratory test result, etc.
50 Years
75 Years
ALL
Yes
Sponsors
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Chonbuk National University Hospital
OTHER
Responsible Party
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Soo-Wan Chae
Principal Investigator, Clinical Trial Center for Functional Foods
Locations
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Clinical Trial Center for Functional Foods Chonbuk National University Hospital
Jeonju, Jeollabuk-do, South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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BA-BF-MBE
Identifier Type: -
Identifier Source: org_study_id
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