Great progress has been made in the clinical trials of youxinding capsule, a new Chinese medicine class 1 drug, of Shanghai innovation and research center of traditional Chinese Medicine

The kick-off training meeting of "phase Ⅱ a clinical trial of youxinding capsule - multicenter, randomized, double-blind, placebo parallel control, dose exploration clinical trial, evaluation of the safety and effectiveness of youxinding capsule in the treatment of depression" attended by psychiatry department and medical psychology department of Nanjing Brain Hospital was held in the conference room on the 5th floor of outpatient building of Nanjing Brain Hospital on the afternoon of June 5, 2013 Recently, as a multi center randomized double-blind placebo-controlled phase IIa clinical trial of dose exploration, it has been successfully completed under the auspices of Shanghai Mental Health Center and the participation of Peking University Sixth Hospital The results of Unblinding showed that youxinding capsule showed a good dose effect relationship within the main dose range, and the effect of the middle and high dose groups showed a better trend than that of the placebo group At the same time, no drug-related serious adverse events were found in each dose group (including the highest dose group), and the incidence of other adverse events was low and mild Once the development of euxindine is successful, a new "heavy bomb" will be born with it, and it may help the patients with depression to get rid of the existing clinical antidepressant drug side effects and enter a new era of safe treatment of depression Youxinding capsule is the first class 1 monomer compound new drug originated from traditional Chinese medicine in the field of spirit in China It is independently developed by Shanghai Traditional Chinese medicine innovation and Research Center, and has independent intellectual property rights including process and application patents Its patent scope covers China, the United States, Germany, France, the United Kingdom, Italy, Sweden, Japan, South Korea and other countries The new drug has obtained the support of national "11th Five Year Plan" and "12th Five Year Plan" major new drug creation projects The development of euxindine originated from the clinical antidepressant effect of traditional Chinese medicine ginseng The compound structure was obtained from the intestinal metabolites after oral administration of ginseng Euxindine is a high purity single compound obtained by semi synthetic method with ginseng as raw material A large number of preclinical trials show that euxindine has a high level of antidepressant activity and a different mechanism from the existing antidepressant drugs Euxindine can protect nerve cells and promote neurogenesis by activating Akt kinase system of nerve cells The mechanism of action is consistent with the latest research on the pathogenesis of depression Experts in clinical trials at home and abroad and many experts in the field of psychotropic drugs in large international pharmaceutical enterprises believe that the dose-response relationship shown in the phase IIa clinical trial of euxindine shows that the middle and high dose groups have entered the effective dose range and reaffirmed the excellent safety of the drug Therefore, this test achieved the expected purpose At the same time, the excellent clinical safety of euxindine provides an important basis for its next clinical research.