A randomized, double-blind, placebo-controlled trial of Shugan Jieyu Capsules for improving sleep and mood disorders during recovery from novel coronavirus pneumonia

Hubei Hospital of Traditional 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. Those who met the diagnostic criteria of New Coronavirus pneumonia convalescence.
•2. The subjects aged from 18 to 70 were male or female;
•3. The subjects with depression, anxiety, poor sleep, fatigue and other sleep emotional disorders as the main clinical manifestations had two symptoms at the same time;
•4. The subjects with HAMD score >= 17 and <= 24 at screening and baseline;
•5. The subjects with PHQ-15 >= 5 in health questionnaire;
•6. Subjects who signed informed consent.

•1. Those patients who are difficult to take oral drugs due to basic diseases and other reasons;
•2. In patients with severe primary diseases and dysfunction such as heart, brain, respiratory, digestive, endocrine, hematopoiesis, liver and kidney, ALT and AST were 2 times higher than the upper limit of normal value, or Cr > 130 umol / L;
•3. Patients with schizophrenia, bipolar disorder, somatoform disorder, mania, anorexia, bulimia and other types of mental diseases, as well as patients with a history of mental diseases;
•4. The subjects with uncooperative mental state, mental illness, lack of self-control and unable to express clearly;
•5. The subjects with severe suicide (HAMD-17 score >= 4) and wounding tendency;
•6. The subjects with allergic constitution were allergic to the drugs involved in the treatment plan;
•7. Pregnant or lactating women;
•8. Subjects participating in other clinical trials;
•9. According to the judgment of the researchers, there will be patients with complications or poor compliance that affect the efficacy and safety evaluation.

发起方

Hubei Hospital of Traditional Chinese Medicine