A randomized, double-blind, placebo-parallel-controlled, multicenter clinical trial reevaluating the efficacy and safety of Qiye Shenan dropping pill in the treatment of insomnia (qi deficiency syndrome)

Xiyuan Hospital, Chinese Academy of Chinese Medical Sciences0 个研究点开始时间: 待定最近更新: 2023年2月20日

适应症

试验速览

暂无简介。

•1. Patients who meet the diagnostic criteria of insomnia;
•2. Patients who meet the diagnostic criteria of insomnia (Qi deficiency syndrome) in TCM;
•3. Aged 45-75 years;
•4. The cumulative score of 7 components of Pittsburgh sleep quality index was 5;
•5. The subjects with informed consent were voluntary and signed informed consent.

•1. Shift workers;
•2. Subjects with secondary insomnia (insomnia related to other mental disorders, sleep disorders caused by medical diseases (insomnia), sleep disorders caused by substances (insomnia), environmental sleep disorders, etc.;
•3. Patients with other sleep disorders: obstructive sleep apnea syndrome (OSAS), restless legs syndrome;
•4. The score of Hamilton Depression Scale (HAMD) was more than 17, and the score of Hamilton Anxiety Scale (HAMA) was more than 14;
•5. The subjects who use other traditional Chinese medicine or Chinese patent medicine or non short acting sedative hypnotics, antidepressants and anxiolytics to treat insomnia within one week; or the subjects who are receiving dual antiplatelet therapy or monoclonal antiplatelet therapy and are prone to bleeding;
•6. Pregnant women and lactating women;
•7. Patients with severe primary heart, liver, kidney, blood or other serious diseases affecting their survival have abnormal liver and kidney functions, ALT and AST >= 1.5 times of the upper limit of normal value, Cr > the upper limit of normal value;
•8. Subjects with suspected or history of alcohol or drug abuse;
•9. Subjects with allergic constitution, such as being allergic to two or more drugs or foods;
•10. Subjects known to be allergic to drug components;
•11. Subjects who participated in clinical trials of other drugs in recent 3 months.

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