A randomized, double-blind, placebo-controlled clinical trial of Shugan Jieyu Capsule on improving sleep disturbance in New Coronavirus pneumonia during convalescence

Phase 4

Recruiting

• Conditions: Patients with sleep mood disorders during recovery from new coronavirus pneumonia

• Registration Number: ITMCTR2100004389
• Lead Sponsor: Hubei Hospital of Traditional Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hamilton Depression Scale;

Secondary Outcome Measures

Name	Time	Method
Hamilton Anxiety Scale;Patient Health Questionnaire-15;Adverse Reaction Scale;Scale of severity of insomnia;