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Clinical Trials/ITMCTR2100004389
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.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
3 years ago
Study Type
Interventional study
Sex
All

Investigators

Sponsor
Hubei Hospital of Traditional Chinese Medicine

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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