A multicenter, randomized, double-blind, placebo-controlled trial for Xiaoyao capsule in the improvement of sleep mood disorder of convalescence patients of novel coronavirus pneumonia (COVID-19)

Not Applicable

Recruiting

• Conditions: novel coronavirus pneumonia (COVID-19); mental health

• Registration Number: ITMCTR2000003249
• Lead Sponsor: Xiaogan Traditional Chinese Medicine Hospital

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. COVID-19 convalescent diagnostic criteria;
2. Cured and discharged patients more than 2 weeks;
3. Aged from 18 to 70 years;
4. Patients with sleep mood disorders such as restlessness, anxiety and sleep disorders were the main clinical manifestations, and those with two symptoms at the same time, or visual analogue scale (VAS) of single symptom >=4;
5. Sign the informed consent.

Exclusion Criteria

1. Patients with difficulty in taking oral drugs due to basic diseases;

2. Accompanied by severe basic diseases affecting survival, including uncontrolled clinically significant heart, lung, kidney, digestion, blood diseases, neuropsychiatric diseases, immune diseases, metabolic diseases, malignant tumors, and severe malnutrition;

3. Allergic constitution, allergic to the drugs involved in the treatment plan;

4. Pregnant or lactating women;

5. Mental state: unable to cooperate, suffering from mental illness, no self-knowledge, and unable to express clearly;

6. Participants in other clinical trials;

7. According to the judgment of the researcher, there will be patients with complicated enrollment or poor compliance, which will affect the efficacy and safety evaluation.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
/A;