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Efficacy and Safety of Angelica Gigas Nakai and Allium Cepa L.Extract Mixtures on the Improvement of Blood Flow

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04389125
Recruitment Status : Unknown
Verified May 2020 by Soo-Wan Chae, Chonbuk National University Hospital.
Recruitment status was:  Recruiting
First Posted : May 15, 2020
Last Update Posted : May 15, 2020
Sponsor:
Information provided by (Responsible Party):
Soo-Wan Chae, Chonbuk National University Hospital

Study Description
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Brief Summary:
This study was conducted to investigate the effects of daily supplementation of Angelica Gigas Nakai and Allium Cepa L.Extract Mixtures on the Improvement of Blood Flow.

Condition or disease Intervention/treatment Phase
Blood Flow Dietary Supplement: Angelica Gigas Nakai and Allium Cepa L.Extract Mixtures Dietary Supplement: Placebo Not Applicable

Detailed Description:
This study was a 12-week, randomized, double-blind, placebo-controlled human trial. 80 subjects were randomly divided into Angelica Gigas Nakai and Allium Cepa L.Extract Mixtures group and a placebo group. It is to evaluate the changes in the displayed evaluation items when taking Angelica Gigas Nakai and Allium Cepa L.Extract Mixtures once a day, in comparison with taking a placebo.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: 12 Weeks, Randomized, Double-blind, Placebo-controlled Human Trial to Evaluate the Efficacy and Safety of Angelica Gigas Nakai and Allium Cepa L.Extract Mixtures on the Improvement of Blood Flow
Actual Study Start Date : January 30, 2020
Estimated Primary Completion Date : April 30, 2021
Estimated Study Completion Date : May 30, 2021
Arms and Interventions
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Arm Intervention/treatment
Experimental: Improvement of Blood Flow group
One packet once a day, after breakfast (1.5 g/day, 1.5 g/day as an Angelica Gigas Nakai and Allium Cepa L.Extract Mixtures)
 Dietary Supplement: Angelica Gigas Nakai and Allium Cepa L.Extract Mixtures
One packet once a day, after breakfast, for 12 week
Placebo Comparator: Placebo group
One packet once a day, after breakfast (1.5 g/day)
 Dietary Supplement: Placebo
Placebo for 12 week


Outcome Measures
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Primary Outcome Measures :
  1. Changes of Platelet function assay(PFA) [ Time Frame: Baseline, 12 week ]
    The concentration of Platelet function assay(PFA) was assessed before and after the intervention

  2. Changes of blood viscosity [ Time Frame: Baseline, 12 week ]
    The concentration of blood viscosity was assessed before and after the intervention


Secondary Outcome Measures :
  1. Changes of systolic blood pressure(SBP), diastolic blood pressure(DBP), Pulse [ Time Frame: screening, 0 week, 6 week, 12 week ]
    systolic blood pressure(SBP), diastolic blood pressure(DBP), Pulse were measured in study screening, visit 1(0 week), visit 2(6 weeks) and visit 3(12 weeks).

  2. Changes of blood coagulation-related indices [ Time Frame: Baseline, 12 week ]
    Blood coagulation-related indices(e.g. Plasminogen activator inhibitor-1, Serotonin, Thromboxane B2, activated partial thromboplastin time) were measured in study visit 1(0 week) and visit 3(12 weeks).

  3. Changes of indicator of lipid metabolism [ Time Frame: Baseline, 12 week ]
    Lipid metabolism(e.g. Total cholesterol, Triglyceride, Low Density Lipoprotein-cholesterol, High Density Lipoprotein-cholesterol, Non High Density Lipoprotein-cholesterol) was measured in study visit 1(0 week) and visit 3(12 weeks).

  4. Changes of atherosclerosis index [ Time Frame: Baseline, 12 week ]
    Atherosclerosis index(e.g. Total cholesterol/High Density Lipoprotein-cholesterol, Low Density Lipoprotein-cholesterol/High Density Lipoprotein-cholesterol, Triglyceride/High Density Lipoprotein-cholesterol, (Total cholesterol-High Density Lipoprotein-cholesterol)/High Density Lipoprotein-cholesterol) was measured in study visit 1(0 week) and visit 3(12 weeks).


Eligibility Criteria
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Ages Eligible for Study:   19 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Participants who meet three or more items
  • Smoker
  • Total cholesterol 180~239 mg/dL before a meal
  • LDL cholesterol 130~159 mg/dL before a meal
  • Glucose 100~125 mg/dL before a meal
  • systolic blood pressure(SBP) is 120~140 mmHg
  • Body mass index(BMI) is 23~30 kg/m^2
  • Waist/Hip ratio(WHR) is 0.9 over for man, 0.85 over for a woman

Exclusion Criteria:

  • Participants with marked impairment of platelet function and platelet coagulation
  • Participants who have anticoagulation within 4 weeks before the screening test
  • Participants with a clinically significant acute or chronic cardiovascular system, endocrine system, immune system, respiratory system, liver biliary system, kidney and urinary system, neuropsychiatry system, musculoskeletal system, Inflammation, blood tumor, gastric disease, etc.
  • Participants with BMI(Body mass index) less than 18.5 kg/m^2 or more than 35 kg/m^2 at the screening test
  • Participants who take medicine or healthy functional foods for platelet function, blood circulation improvement, and hyperlipidemia within 4 weeks before the screening test
  • Participants receiving antipsychotic medication within 3 months prior to the screening test
  • Participants suspected of alcoholism(21 unit/week) or substance abuse
  • Participants who have participated in other clinical trials within 3 months prior to the screening test
  • Participants who show the following relevant results in a Laboratory test º Aspartate Transaminase(AST), Alanine Transaminase(ALT) > Reference range 3 times upper limit º Serum Creatinine > 2.0 mg/dl
  • Women who are pregnant or breastfeeding
  • Women who may become pregnant and have not used appropriate contraceptives
  • Participants who the principal investigator judged inappropriate for the participant in this study because of a laboratory test result, etc
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04389125


Contacts
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Contact: Soo Wan Chae, Ph.D., M.D. 82-63-259-3040 soowan@jbnu.ac.kr

Locations
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Korea, Republic of
Clinical Trial Center for Functional Foods Chonbuk National University Hospital Recruiting
Jeonju, Jeollabuk-do, Korea, Republic of, 54907
Contact: Soo-Wan Chae, MD., PhD    82-63-259-3040    swchae@jbctc.org   
Sponsors and Collaborators
Chonbuk National University Hospital
More Information
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Responsible Party: Soo-Wan Chae, Principal Investigator, Clinical Trial Center for Functional Foods, Chonbuk National University Hospital
ClinicalTrials.gov Identifier: NCT04389125    
Other Study ID Numbers: HJ-BF-AAM
First Posted: May 15, 2020    Key Record Dates
Last Update Posted: May 15, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No