Development and Evaluation of Technical Standards for Diagonosis and Treatment of Integartive Medicine for Insomnia

Guangdong Provincial Hospital of Chinese Medicine0 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. Adults diagnosed with insomnia using the DSM-5 and ICSD-3;
•2. Aged 18 to 65 years;
•3. Pittsburgh Sleep Quality Index (PSQI) >7 during the screening period and at baseline;
•4. Insomnia severity index (ISI)>7 during the screening period and at baseline;;
•5. Stable vital signs with certain expression and cognitive ability;
•6. Volunteer to participate in this clinical trial and sign an informed consent form.

•1. Participants with other related medical history that may affect sleep including narcolepsy, circadian rhythm sleep disorder, sleepwalking, sleep-related breathing disorder, obstructive or central sleep apnea syndrome, restless legs syndrome, etc.;
•2. Participants with sever mental illnesses or emotional and behavior disorder disorder (such as schizophrenia, suicidal tendency or suicide history) in the past year, or long-term use of central nervous system depressant or stimulant drugs;
•3. Insomnia caused by other conditions in the past month, such as pain, fever, cough, surgery, interference from the external environment, etc.;
•4. Liver function AST and ALT exceed the upper limit of normal reference value by 1.5 times, or Scr exceeds the upper limit of normal reference value.
•5. Participants with severe cardiovascular, lung, liver, kidney, endocrine or central nervous system diseases;
•6. Drug and alcohol abuse or dependence;
•7. Participants with allergic reaction to the test drug or its ingredients;
•8. Pregnant or lactating women, women of childbearing age who cannot take contraceptive measures during the trial;
•9. Participants participate in other drug clinical trials within the past month;
•10. Researchers consider the participant is inappropriate to participate in this clinical trial.

发起方

Guangdong Provincial Hospital of Chinese Medicine