摘要
由于骨关节炎的诊断和疗效尚无全国性统一标准，本文根据文献报道和以往的临床试验设计，按照中药新药临床指导原则的要求，初拟一个Ⅱ期临床试验方案，并希望通过此临床试验，对治疗膝关节骨关节炎的中药新药。
A generally recognized standard of diagnosis and evaluation of effect for osteoarthritis has not been established in our country up to now. In this paper, a program of Ⅱ_stage clinical trial was proposed according to literature and past experiences relevant to such design and the Clinical Guideline for Chinese Drug.It is expected that this study may supply an objective evaluation for the safety and efficacy of new Chinese drug for osteoarthritis of knee joints.
出处
《中药新药与临床药理》
CAS
CSCD
1998年第1期16-18,共3页
Traditional Chinese Drug Research and Clinical Pharmacology
关键词
骨关节炎
中医药疗法
临床试验
Osteoarthritis/TCD therapy
Clinical Trials/methods
Clinical protocols/stand
