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KMID : 1123920140280060662
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Korean Journal of Oriental Physiology and Pathology
2014 Volume.28 No. 6 p.662 ~ p.667
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Development of Clinical Protocol on the Correlation Between Disease Cause Pattern Identification and Pulse Wave Variables
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Kim Ji-Hye
Yu Ha-Na
Ku Bon-Cho
Kim Hyun-Ho
Kim Jong-Yeol
Jeon Young-Ju
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Abstract
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The purpose of this clinical study is to develop structured clinical trial protocol and guideline for improvement of safety, useful and effective of pulse diagnosis devices. As a first step, papers on pulse diagnosis and pulse diagnosis devices from 2001 and 2013 were systematically reviewed. In the next step, we have collected the opinions from the specialists, companies, and statistician in pulse diagnosis to evaluate the current condition, the state and problem of domestic clinical trial cases of pulse diagnosis device. And we have to created protocol and case report form (CRF) in regards to site condition and characteristics of pulse diagnosis devices, and showed the guideline of eligibility criteria, operation process, investigation items, evaluation items and so on. This clinical protocol will become a basic information for a researcher in designing or performing a clinical study of pulse diagnosis devices, and be used as a useful material during acquisition of good clinical data. Furthermore, we hope to enhance the invigoration of pulse diagnosis clinical trials and the performance improvement of pulse diagnosis devices.
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KEYWORD
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Clinical Protocol, Pulse diagnosis device, Disease Cause Pattern Identification(病因辨證), Pulse Wave Variables
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