Clinical trial NCT04389125: Efficacy and Safety of Angelica Gigas Nakai and Allium Cepa L.Extract Mixtures on the Improvement of Blood Flow
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Blood Flow
Lead sponsor: Chonbuk National University Hospital
Sponsor class: OTHER
First posted: 2020-05-15
Enrollment: 80
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility 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

Primary outcomes:
measure: Changes of Platelet function assay(PFA)
timeFrame: Baseline, 12 week
measure: Changes of blood viscosity
timeFrame: Baseline, 12 week
Secondary outcomes:
measure: Changes of systolic blood pressure(SBP), diastolic blood pressure(DBP), Pulse
timeFrame: screening, 0 week, 6 week, 12 week
measure: Changes of blood coagulation-related indices
timeFrame: Baseline, 12 week
measure: Changes of indicator of lipid metabolism
timeFrame: Baseline, 12 week
measure: Changes of atherosclerosis index
timeFrame: Baseline, 12 week
Other outcomes:
Locations:
city: Jeonju
country: Korea, Republic of
facility: Clinical Trial Center for Functional Foods Chonbuk National University Hospital
state: Jeollabuk-do
Study officials:
References: