Clinical study on significant antihypertensive effects of two Rg3 enriched Korean ginsengs

Not Applicable

Completed

• Conditions: Diseases of the circulatory system

• Registration Number: KCT0008475
• Lead Sponsor: Dankook Univeristy Hospital

Brief Summary

1) The two test groups (the vitamin ginseng group and the enzyme red ginseng group) statistically significantly reduced SBP at 12 weeks compared to the control group (vitamin ginseng p<0.001, enzyme red ginseng p<0.001) 2) In the case of DBP, both the vitamin ginseng and the enzyme red ginseng groups showed a significant reduction effect at the point of 12 weeks (vitamin ginseng p=0.012, enzyme red ginseng p=0.001) 3) Compared to the control group, the two test groups (the vitamin ginseng group and red ginseng group) significantly lowered arterial pressure at 12 weeks (vitamin ginseng p<0.001, enzyme red ginseng p<0.001) 4) There were no serious adverse event in both the vitamin ginseng and the enzyme red ginseng extracts, and other adverse event showed no significant difference from the control group Both the vitamin ginseng and the enzyme red ginseng were effective in lowering SBP, DBP and arterial blood pressure at 12 weeks of administration compared to placebo. Nitric oxide(NO) and hs-CRP levels did not show significant changes. There were no significant or additional adverse reactions in both the vitamin ginseng and the enzyme red ginseng extracts.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2021-10-07
• Last Update Posted: 30 May 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

1. Men and women aged between 20 and 70 years.
2. Participants for whom after resting 5 min in a sitting position, the average SBP measured twice with a 2-minute interval was 125-245 mmHg,
or the DBP was in the range of 80-95 mmHg, except for those who required medication. For those with stage 1 hypertension, the SBP range was
140-145 mmHg or the DBP was 90-95 mmHg.
3. People who voluntarily decided to participate and agreed in writing to abide by the precautions after hearing and fully understanding the detailed
explanation of this study.

Exclusion Criteria

1. Participants having a history of hypersensitivity and a habit of ginseng and red ginseng consumption.
2. Those who have taken blood pressure-lowering drugs or blood circulation improving drugs (ginkgo leaf extract, aspirin, etc.).
3. Participants who have taken herbal medicines, peptides-containing medicines/food, oral steroids, or hormones within the last one month.
4. Participants who are under treatment for alcoholism or being treated for thyroid dysfunction.
5. Diabetic patients who are currently taking medications.
6. Those who underwent surgery within the last six months.
7. People having severe renal or hepatic dysfunction.
8. Those who have had surgery that may affect drug absorption, such as gastrectomy.
9. Pregnant, lactating, and childbearing women who do not use appropriate contraceptive methods.
10. Those who have consumed other clinical trial foods or test drugs within the last two months.
11. Those who have donated blood within the last two months.
12. Patients with uncontrolled hypertension (160/100 mmHg) or those who are taking new medications due to high blood pressure within the
last three months.

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Determined based on the systolic blood pressure (SBP), and the diastolic blood pressure (DBP)

Secondary Outcome Measures

Name	Time	Method
mean arterial blood pressure (MBP) and average pulse, NO production in blood, and highly sensitive C-reactive protein (hs-CRP)