Effect of Garlic Extracts on Changes in Cerebral Blood Flow

NCT ID: NCT05349253

Last Updated: 2022-04-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-27
• Study Completion Date: 2021-03-31

Brief Summary

The purpose of this study is to assess the safety and efficacy of Garlic extracts for improving of cerebral blood flow.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Garlic extracts

Take 450mg of Garlic extracts(Food Item Making Report Product Name: Vegetable Extract Powder No. 1905, Item Report No.: 202004980275)

Group Type: EXPERIMENTAL

Garlic extracts

Intervention Type: DIETARY_SUPPLEMENT

One intake in total

placebo

As a food ingredient that does not affect blood pressure and is harmless to the human body, it is made almost identical in weight and appearance to garlic extract.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

One intake in total

Interventions

Garlic extracts

One intake in total

Intervention Type: DIETARY_SUPPLEMENT

Placebo

One intake in total

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

1. Healthy adults 19 years of age or older as of the screening date

2. Those with no history of treatment for hypertension within the last 3 months

3. A person who voluntarily decides to participate and agrees in writing to abide by the precautions after hearing and fully understanding the detailed explanation of this study

Exclusion Criteria

1. Those with systolic blood pressure of 160 mmHg or higher or diastolic blood pressure of 100 mmHg or higher

2. Those who have had a stroke, myocardial infarction, percutaneous coronary angioplasty or surgery for coronary angioplasty within the past 6 months

3. Persons with acute and severe cardiovascular diseases such as heart failure, myocardial infarction, and stroke

4. Those with acute/chronic inflammation such as cancer, rheumatic disease, autoimmune disease, gastrointestinal disease, etc.

5. Those who have a history of gastrointestinal diseases (eg Crohn's disease) or gastrointestinal surgery (except simple appendicectomy or hernia surgery) that may affect the absorption of the product for human application testing

6. Persons who have taken prohibited concomitant drugs within the last 3 months

7. Persons with a history of clinically significant hypersensitivity reactions to drugs and health functional foods

8. Those who have received antipsychotic drug treatment within 2 months before the screening test

9. Persons with a history of drug or alcohol abuse

10. Pregnant or lactating women

11. When women of childbearing potential of childbearing potential do not accept the implementation of appropriate contraceptive methods (except for women who have undergone sterilization)

12. Subjects who have participated in health functional food related research or clinical trials within the last 3 months

13. In case the principal investigator judges that it is not appropriate to participate in this study

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Pusan National University Yangsan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yong-il Shin

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Pusan national university Yangsan Hospital

Gyeongsang, Yangsan, South Korea

Countries

South Korea

Other Identifiers

04-2020-036

Identifier Type: -

Identifier Source: org_study_id