继1986年完成制定“关于医用汉方提取物制剂的使用”之质量统一标准与应用的工作之后,目前正在进行重新评价药效的“临时再评价”。在实施前的探讨阶段,发现在临床评价方法方面存在许多汉方制剂的独特问题。如汉方药的气味、证等,即进行双盲随机比较临床试验,制作安慰剂如何解决汉方药特殊的气味?“证”的概念如何写入临床试验 Following the completion of the work on the development of a unified standard for quality and application of “the use of pharmaceutical extracts of Chinese medicines” in 1986, it is currently undergoing a “temporary re-evaluation” of drug efficacy. During the pre-implementation phase of the study, it was found that there are many unique problems with Kampo preparations in terms of clinical evaluation methods. Such as the Kampo medicine’s odor, card, etc., that is to conduct a double-blind randomized comparison clinical trials, how to produce a placebo how to solve the special odor Kampo medicine? The concept of “certificate” how to write clinical trials