ITMCTR2100004389
Recruiting
Phase 4
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 sitesTBD
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Patients with sleep mood disorders during recovery from new coronavirus pneumonia
- Sponsor
- Hubei Hospital of Traditional Chinese Medicine
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Not specified
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