Status:

UNKNOWN

Efficacy and Safety Morus Alba L. Extract on Improvement of Blood Flow

Lead Sponsor:

Chonbuk National University Hospital

Conditions:

Blood Flow

Eligibility:

All Genders

50-75 years

Phase:

NA

Brief Summary

The effect of 12 weeks intake of Morus alba L. on blood circulation improvement and related indicators is assessed compared to placebo intake.

Detailed Description

This study was a 12 weeks, randomized, double-blind, placebo-controlled human trial. Hundred subjects were randomly divided into Morus alba L. extract or a placebo group. Blood was collected and chang...

Eligibility Criteria

Inclusion

  • Those with a fasting total cholesterol of 200\~239 mg/dL
  • 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

  • Those with platelet aggregation and significant disability
  • 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.

Key Trial Info

Start Date :

November 12 2018

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

January 31 2021

Estimated Enrollment :

100 Patients enrolled

Trial Details

Trial ID

NCT03807570

Start Date

November 12 2018

End Date

January 31 2021

Last Update

May 8 2020

Active Locations (1)

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Clinical Trial Center for Functional Foods Chonbuk National University Hospital

Jeonju, Jeollabuk-do, South Korea, 54907