Analysis Of Clinical Trial Design For Traditional Chinese Drug Faqs

Clinical trial design is an important part of pharmaceutical researches.The scientific and objective evaluation of efficacy of Chinese medicine is based on the rigorous and scientific designs of clinical trials.The promulgation and implementation of Good Clinical Practice and Chinese Medicine Clinical Research Guiding Principles,and the application of clinical epidemiology in TCM Clinical Efficacy Evaluation promote the development of clinical trials of Chinese medicine.However,clinical trials of Chinese medicine have many problems,which influence evaluation of the effect of Chinese medicine.The thesis discusses some common problems in the designs of clinical trial of Chinese medicine.Objective:To embody all the advantages of traditional chinese medicine and improve the quality of clinical trial,This thesis discusses some problems in the designs of clinical trials.Methods:The thesis summarizes and analyzes problems which influence evaluation of therapeutic efficiency in the design of new drugs in clinical trials of Chinese medicine,and then proposes corresponding solutions.In the last,to embody all the advantages of traditional chinese medicine and improve the quality of clinical trial, combined with example of the clinical trial of treating psychological erectile dysfunction with Compound Kidney-Nourishing Particles,the thesis puts forward consulting opinions about problems in the clinical trial.Results:The first prat is literature review,which reviews the common problems in the design of clinical trial of Chinese medicine and discusses inaccuracy syndrome,unsuitable control medicine,no precise blind method,too much subjectivity in standards of syndrome-differentiated diagnosis,compliance and security.Based on the literature review,the second part makes a critical analysis on the problems in the designs of clinical trial of Chinese medicine,including the model choice between combination of disease and syndrome and syndrome,lack of syndrome changes treatment in therapeutic process,too much subjectivity in standards of syndrome-differentiated diagnosis,ill-chosen medicine in control group and mismanagement of drug combination,and sets forth countermeasures.To embody all the advantages of traditional chinese medicine and improve the quality of clinical trial,combined with example of the clinical trial of treating psychological erectile dysfunction with Compound Kidney-Nourishing Particles,the third part puts forward consulting opinions about problems in the clinical trial,including unreasonable differentiation of symptoms and signs,lack of syndrome changes treatment in therapeutic process,no precise blind method,mismanagement of drug combination and incomplete indexes of effect judgement.Conclusion:Handling of problems reasonably,such as inaccuracy syndrome,unsuitable control medicine,no precise blind method,too much subjectivity in standards of syndrome-differentiated diagnosis,the model choice between combination of disease and syndrome and syndrome,compliance and security,lack of syndrome changes treatment in therapeutic process and mismanagement of drug combination,can embody all the advantages of traditional chinese medicine.