Authors
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[No authors listed]
Category
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Primary study
Registry of Trials»Korean Clinical Trials Database
Year
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2023
INTERVENTION: Dietary Supplement : In this study, 12 weeks, randomized, double‐blind, and placebo‐controlled clinical trial was conducted to evaluate the efficacy and safety of Rg3‐enriched Korean ginsengs for moderate hypertensive cases. Participants who satisfied all the following criteria were selected: 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. The exclusion criteria were as follows: 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 si Xmonths. 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. CONDITION: Diseases of the circulatory system PRIMARY OUTCOME: Determined based on the systolic blood pressure (SBP), and the diastolic blood pressure (DBP) SECONDARY OUTCOME: mean arterial blood pressure (MBP) and average pulse, NO production in blood, and highly sensitive C‐reactive protein (hs‐CRP) 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.
Epistemonikos ID: 82fe9e24fb35fef1601ef6a893ae0431dfa906c2
First added on: Feb 20, 2024