根据现行法规和国际惯例 ,严格而规范的随机双盲对照试验主要应用于承上启下的Ⅱ期临床试验。但在实际中 ,对它的理解不够正确或实际操作不够规范的事例还很常见 ,有必要对其基本原理与符合国际规范的操作方法作一扼要的介绍。同时 ,为了促进中药临床试验与国际接轨的过程 ,特 According to the current laws and regulations and international practice, a rigorous and standardized randomized double-blind controlled trial is mainly used in connection with the phase Ⅱ clinical trials. However, in practice, it is not uncommon to find that it is not properly understood or that the practice is not standardized enough. Therefore, it is necessary to give a brief introduction of its basic principles and operation methods in line with international norms. At the same time, in order to promote the process of clinical trials of Chinese medicine and international standards, especially