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| Highlight of Clinical research design and evaluation of Chinese materia medica for the treatment of pediatric diarrhea |
| Hits 1457 Download times 1247 Received:April 20, 2018 |
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| DOI
10.11656/j.issn.1672-1519.2018.08.02 |
| Key Words
Chinese materia medica;pediatric diarrhea;clinical trial;design and evaluation |
| Author Name | Affiliation | | HU Siyuan | The First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China | | LI Xiaoxuan | Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China
Tianjin Binhai New District Women and Children Care and Family Planning Service Center, Tianjin 300459, China |
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| Abstract
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| Diarrhoea is a common syndrome in pediatrics which can be treated effectively by Chinese materia medica. This paper mainly elaborates the key technical points and characteristics of clinical trial design,implementation and evaluation of Chinese materia medica for this disease. It included indication selection, objective, overall design, standards of diagnostic and clinical classification,standards of syndrome differentiation, subject selection, treatment regimen, efficacy and safety evaluation, quality control of the experiment, etc. All of these problems were analyzed in detail not only through referring to the newest diagnosis,treatment and drug evaluation guidelines but conducting a survey of the related clinical trail at home and abroad combined with the author's many years of practical experience. The main aim is to enrich the methodological contents of clinical evaluation and to improve the level of clinical trail design. |
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