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| Interpretation of the technical specification for clinical trial design and evaluation of traditional Chinese medicine in the treatment of carotid atherosclerosis(version 2021) |
| Hits 731 Download times 690 Received:October 11, 2021 |
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| DOI
10.11656/j.issn.1672-1519.2022.04.07 |
| Key Words
carotid atherosclerosis;interpretation;randomized controlled trial;Chinese medicine |
| Author Name | Affiliation | E-mail | | LI He | The Second Ward Department of Brain Disease, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing 100700, China | | | JI Hanrui | The Second Ward Department of Brain Disease, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing 100700, China | | | WU Shenxian | National Drug Clinical Trial Institution, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing 100700, China | wushx@sina.com |
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| Abstract
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| The technical specification of clinical trial design and evaluation is an important reference to guide the development of clinical trials of traditional Chinese medicine. After more than one year,the group standard of the Chinese society of traditional Chinese medicine Technical Guidelines for Clinical Trial Design and Evaluation of Traditional Chinese Medicine in the Treatment of Carotid Atherosclerosis was officially released on March 16,2021. I would like to elaborate on the clinical positioning,overall trial design,diagnostic and syndrome differentiation standards,administration scheme and other issues in the evaluation technical specifications formulated by the research team,in order to answer some queries and provide reference for relevant personnel to carry out the clinical trial of traditional Chinese medicine in the treatment of carotid atherosclerosis. |
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