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

Chonbuk National University

Status: Unknown

Conditions: Blood Flow

Treatments: Dietary Supplement: Morus Alba L. Extract; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03807570

BA-BF-MBE

Details and patient eligibility

About

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

Full 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 changes in blood circulation related indicators were observed.

Enrollment: 100 estimated patients

Sex: All

Ages: 50 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups, including a placebo group

Morus Alba L. extract

Experimental group

Description:

Morus Alba L. extract 30 ml/day for 12 weeks

Treatment:

Dietary Supplement: Morus Alba L. Extract

Placebo

Placebo Comparator group

Description:

Placebo 30 ml/day for 12 weeks

Treatment:

Dietary Supplement: Placebo