Dose Finding and Safety Study of 12-weeks Repeated Intakes of Sesame Peptides (KM-20) on Mild Hypertensive Subjects
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Accession number;04A0411205
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| Title;Dose Finding and Safety Study of 12-weeks Repeated Intakes of Sesame Peptides (KM-20) on Mild Hypertensive Subjects |
| Author;
NAKAMURA EIICHI
(Kishimoto Sangyo Co., Ltd., JPN)
HIRAKAWA YOICHI
(Kishimoto Sangyo Co., Ltd., JPN)
TO YASUO
(Aiwakurinikku)
NAGAOKA HIROMASA
(Aiwakurinikku)
SHOJI YOKO
(St. Marianna Univ. School of Medicine, JPN)
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Journal Title;Japanese Pharmacology & Therapeutics
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Journal Code:Z0947A
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ISSN:0386-3603
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VOL.32;NO.4;PAGE.239-249(2004)
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| Figure&Table&Reference;FIG.6, TBL.5, REF.20 |
| Pub. Country;Japan |
| Language;Japanese |
| Abstract;Objectives: Sesame peptide (KM-20) on changes of blood pressure (BP) in volunteers with either high normal blood pressure or mild hypertension. Methods: A study of 58 subjects volunteers including 37 males and 21 females, whose averaged year was 52.2, were divided into four groups: 1; control, 2; subjects with BP at 145.4/88.7mmHg, 3; subjects with BP at 145.7/88.1mmHg, and 4; subjects with BP at 149/89.3mmHg. Placebo capsules were administered in the control group. Low dose of KM-20 (250mg/capsule) was administared to the group 2. Middle dose of KM-20 (500mg/capsule) was given to the group 3 and high dose of KM-20 (1000mg/capsule) was given to the group 4. Each group was given 4 capsules by orally once a day for 12 weeks. The BP was monitored every other two weeks. Results: After 10 weeks intake of KM-20, systolic blood pressure (SBP) of subjects treated with 1000mg of KM-20 was significantly decreased (p<0.05 vs. control). Six after the administration, the changing of SBP of subjects treated with of KM-20 (1000mg) was significantly big (p<0.05) compared to that control group, and 250mg group. However 500mg group was just showed significant (p<0.05) with 1000mg group at the point of 6 weeks intakes. This phenomen on was dose dependent. None of side effect and serious adverse event was observed in any tasted groups. Also, neither abnormality in laboratory data nor adverse reactions, such as digestive tract symptoms and dry cough was observed during the test period. These results suggested that KM-20 would be useful for controlling BP in subjects with mild hypertension or high normal blood pressure. The optimum dose of KM-20 would be at a dose of either 500 or 1000mg/day from this test. (author abst.) |
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