Skip to content

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

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

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2100004389
Enrollment
Unknown
Registered
2021-02-05
Start date
2020-07-01
Completion date
Unknown
Last updated
2023-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with sleep mood disorders during recovery from new coronavirus pneumonia

Interventions

Sponsors

Hubei Hospital of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion 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 = 5 in health questionnaire; 6. Subjects who signed informed consent.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
Hamilton Depression Scale;

Secondary

MeasureTime frame
Hamilton Anxiety Scale;Patient Health Questionnaire-15;Adverse Reaction Scale;Scale of severity of insomnia;

Countries

China

Contacts

Public ContactQing Zhang/ Li Li/ Yuanming Ba

Hubei Hospital of Traditional Chinese Medicine

15121210@qq.com+86 13397107505

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026