Clinical trials of traditional Chinese medicine research and evaluation.docVIP

 PAGE \* MERGEFORMAT 13 Clinical trials of traditional Chinese medicine research and evaluation [Keywords:] evaluation of clinical trials of traditional Chinese medicine As the public health care and quality of life in the pursuit of constant improvement of the safety and efficacy of Chinese medicine is also a growing concern. A traditional Chinese medicine and status stages of clinical trials Clinical trials of traditional Chinese medicine began more than 20 years ago, the past 10 years showed a rising trend in Phase I clinical trials into clinical trials (pharmacokinetics, tolerance test), II Phase I clinical trials (exploratory trials), III clinical trials (confirmed test), IV Phase I clinical trials (applied test). In recent years, the literature published in domestic journals, clinical trials papers on the medicine gradually increased, but in clinical studies, there are still many problems, including: study design and the quality of reporting is not high, randomly applied inappropriately, there is not enough sample size to observe the indicators are not clear; syndrome or whether it is effective to determine indicators are difficult to achieve standardization and quantification; report on the efficacy of low reproducibility, and the efficacy of clinical symptoms of multiple indicators of ‘soft’ targets, the lack of long-term follow-up obtained by the end of the ‘hard’ indicators (such as mortality, disability, etc.). These issues will affect the reliability of the results of the study, therefore, the scientific value of its testing is difficult to gain international recognition. Randomized controlled trials of Chinese medicine articles in the design, implementation and reporting, there are still ways, such as a description of randomization, blind use of the definition of compliance and efficacy aspects of [1]. Two clinical safety evaluation of traditional Chinese medicine Clinical safety evaluation of traditional Chinese medicine clinicians, patient