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Chinese medicine clinical trial protocol design FAQs analysis

Author: XieZhiMin
Tutor: DuBaoJun
School: China Academy of Traditional Chinese Medicine
Course: Chinese medical science
Keywords: Chinese Drug Research Clinical trial design Functional erectile dysfunction Evaluation
CLC: R288
Type: Master's thesis
Year: 2009
Downloads: 298
Quote: 0
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Abstract


Clinical trial design is an important part of drug research, rigorous, on the scientific basis for the design of clinical trials, scientific, objective evaluation of Chinese medicine clinical efficacy. Pharmaceutical clinical trial management norms \play a positive role in promoting. However, there are many unreasonable problems in the experimental design of the Traditional Chinese Drug Research, affect the evaluation of the efficacy. This article is to discuss the technical issues prevalent in the Chinese medicine clinical trial design. Objective: To analyze the experimental design, many affecting the efficacy evaluation issues and proposed amendments to the clinical trial protocol design more in line with the characteristics of Chinese medicine treatment of diseases of the, more able to reflect the Chinese medicine treatment advantages, in order to improve the quality of clinical trials. Methods: Summary of Chinese medicine clinical trial design in recent years, the literature Summing existing FAQs, combined with experience in Chinese medicine clinical trial design and analysis of issues related to the experimental design, and propose solutions to countermeasures. Final choice of the representative (to reflect the characteristics and advantages of Chinese medicine treatment of functional diseases) Chinese medicine clinical research program, Analysis of the various problems arising in the design of the \The proposed changes, to improve the design of clinical trials to improve the quality of the evaluation of the clinical efficacy of Chinese medicine. Results: The first part through literature finishing, summarized the common problems in recent years, Chinese medicine clinical design, found to exist, such as check against waiting establish unreasonable, inappropriate choice of control drug, blinded to implement less rigorous syndrome quantify arbitrary compliance and security issues. The second part is to organize small summary on the basis of the literature review, combined with the problems encountered in the Chinese medicine clinical trial design, disease and syndrome patterns and syndromes mode selection problem to deal with the problem of climate change, the course of treatment certificate the canonicalization issues Syndrome, a reasonable choice to control drug problem and the concomitant medication problems many clinical evaluation of the more critical issues to analyze and propose solutions countermeasures. The third part of the analysis combined with functional specific instances of erectile dysfunction, the compound Bushen Granule treatment of functional erectile dysfunction clinical trial program \indicators and many other issues proposed revisions. Conclusion: syndromes establish unreasonable, inappropriate choice of control drug, blinded to implement less rigorous syndrome standardization issues, not detailed binding mode of the syndromes, compliance issues, security issues, concomitant medications, efficacy in clinical trials reasonable decision index is not comprehensive and unprocessed trials syndrome change treatment, the clinical trial protocol design more in line with the characteristics of Chinese medicine treatment of diseases, and to reflect the advantages of Chinese medicine treatment.

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