Objective To evaluate the clinical effect and safety of Yinao Capsul es for neurasthenia with the syndrome of liver-kidney deficiency and Qi-yin de ficiency. Methods A multi-center,randomized,single-blind and positive drug p arallel controlled trial was adopted. Three hundred and forty-two cases in the treatment group were treated with Yinao Capsules,and 111 cases in the control g roup were treated with Naolinsu Capsules. Results Yinao Capsules had a total eff ective rate of 93.6 %and the markedly effective rate of 52.1 %. Compared with Naolinsu Capsules,Yinao Capsules showed a better clinical effect (P

Model-induced drug development （MIDD） is a mathematical and statistical method for constructing， validating and utilizing disease model， drug exposure-response model and pharmaceutical model to promote drug development. With the development of pharmaceutical technology， MIDD is widely used in the field of traditional Chinese medicine and has high practical value. This article summarizes the relevant literature at home and abroad， and finds that MIDD has the advantages of improving the research and development efficiency of traditional Chinese medicine， quickly identifying the applicable population of traditional Chinese medicine， predicting the interaction of drugs， and optimizing the dosage. MIDD has been applied in the studies of effective components of traditional Chinese medicine， quantitative design of prescription， dosage form and preparation process， pilot scale- up， quality and safety， regulatory decision-making and evaluation， etc.