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

Blood Flow Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04389125
• Other study ID #: HJ-BF-AAM
• Status: Recruiting
• Phase: N/A
• Start date: January 30, 2020
• Est. completion date: May 30, 2021

Study information

• Verified date: May 2020
• Source: Chonbuk National University Hospital
• Contact: Soo Wan Chae, Ph.D., M.D.
• Phone: 82-63-259-3040
• Email: soowan[@]jbnu.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: May 30, 2021
• Est. primary completion date: April 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Blood Flow

Intervention

Dietary Supplement:
• Angelica Gigas Nakai and Allium Cepa L.Extract Mixtures
One packet once a day, after breakfast, for 12 week
• Placebo
Placebo for 12 week

Locations

Country	Name	City	State
Korea, Republic of	Clinical Trial Center for Functional Foods Chonbuk National University Hospital	Jeonju	Jeollabuk-do

Sponsors (1)

Lead Sponsor	Collaborator
Chonbuk National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes of Platelet function assay(PFA)	The concentration of Platelet function assay(PFA) was assessed before and after the intervention	Baseline, 12 week
Primary	Changes of blood viscosity	The concentration of blood viscosity was assessed before and after the intervention	Baseline, 12 week
Secondary	Changes of systolic blood pressure(SBP), diastolic blood pressure(DBP), Pulse	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).	screening, 0 week, 6 week, 12 week
Secondary	Changes of blood coagulation-related indices	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).	Baseline, 12 week
Secondary	Changes of indicator of lipid metabolism	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).	Baseline, 12 week
Secondary	Changes of atherosclerosis index	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).	Baseline, 12 week