Planta Med 2011; 77(3): 221-225
DOI: 10.1055/s-0030-1250237
Clinical Study
Original Papers
© Georg Thieme Verlag KG Stuttgart · New York

Clinical Evaluation of Efficacy and Tolerability of HMC05 in Healthy Subjects with Normal and High-Normal Blood Pressure: A Pilot Study

Hae Won Lee1 , 2 [*] , Mi-sun Lim1 , 2 , 3 [*] , Sook Jin Seong1 , 2 , 3 , Jeonghyeon Park1 , 2 , 3 , Joomi Lee1 , 2 , 3 , Jeong Ju Seo1 , 2 , 3 , Sung-Doo Kim2 , Heung-Mook Shin4 , Young-Ran Yoon1 , 2 , 3
  • 1Department of Biomedical Science, Kyungpook National University Graduate School, Daegu, Korea
  • 2Clinical Trial Center, Kyungpook National University Hospital, Daegu, Korea
  • 3BK21 Program, Kyungpook National University School of Medicine, Daegu, Korea
  • 4Department of Physiology, Dongguk University College of Oriental Medicine, Kyongbuk, Korea
Further Information

Publication History

received May 31, 2010 revised July 8, 2010

accepted July 12, 2010

Publication Date:
17 August 2010 (online)

Abstract

HMC05, a formulation containing eight different herbal extracts, has been used widely for several thousand years in China, Japan, and Korea as a remedy for hypertension and headache. Although its anti-inflammatory effects in mouse monocytic cell lines and anti-atherosclerotic effects in apoE-knockout mice have been reported, the pharmacodynamic effects of HMC05 in human subjects have not yet been investigated. We evaluated the efficacy and tolerability of this drug in 14 healthy male Korean subjects with normal or high-normal blood pressure (BP) in a randomized, single-blind, crossover study with a 2-week washout period. Four 500-mg tablets of HMC05 or placebo were orally administered three times daily to nine subjects with normal BP and five subjects with high-normal BP for 4 weeks. To assess the pharmacodynamic effects of HMC05, levels of high-sensitivity C-reactive protein and homocysteine, BP, and flow-mediated vasodilation were measured before and after the 4-week medication period with evaluation of tolerability. All 14 subjects completed the study, and HMC05 was well tolerated with no significant adverse events. HMC05 did not exhibit a significant BP-lowering effect in either BP group, and there were no significant differences in other pharmacodynamic values after HMC05 or placebo administration in the two groups. Further study is needed to evaluate the efficacy and tolerability of HMC05 in an adequate number of patients with hypertension.

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1 Both authors contributed equally to this work.

Associate Prof. Young-Ran Yoon

Department of Molecular Medicine and Clinical Trial Center
Kyungpook National University School of Medicine and Hospital

200 Dongduk-Ro

Jung-gu

700-721 Daegu

Korea

Phone: +82 5 34 20 49 50

Fax: +82 5 34 22 49 50

Email: yry@knu.ac.kr

Prof. Heung-Mook Shin

Department of Physiology
Dongguk University College of Oriental Medicine

Sukjangdong

780-714 Gyongju

Korea

Phone: +82 5 47 70 23 61

Fax: +82 5 47 42 54 41

Email: heungmuk@dongguk.ac.kr