Qingjin Yiqi Granules for patients in pneumonia recovery phase (COVID-19, Omicron): a clinical study

Phase 1

Recruiting

• Conditions: Pneumonia recovery phase (COVID-19, Omicron)

• Registration Number: ITMCTR2200005627
• Lead Sponsor: Second Affiliated Hospital of Tianjin University 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) Patients who meet the diagnostic and discharge criteria for COVID-19, and who have been negative for 2019-nCoV nucleic acid test after discharge.
2) Pediatric patients are less than or equal to 14 years; adult patients are older than 14years.
3) Patient informed consent.

Exclusion Criteria

1) Patients who have undergone operations that affect lung function, such as lung transplantation, lung resection, lung volume reduction, etc;
2) Patients who rely on mechanical ventilation to maintain lung function, such as ventilators;
3) Combined with chronic lung diseases that affect lung function, such as severe chronic obstructive pulmonary disease;
4) Patients complicated with diseases affecting cardiac function, such as patients with heart failure and pacemakers, etc;
5) Accompanied by severe underlying diseases, such as uncontrolled heart, kidney, digestive, hematologic, neuropsychiatric, immune, metabolic diseases of clinical significance, malignant tumor, and severe malnutrition, etc;
6) Resting heart rate > 120/min;
7) Systolic blood pressure > 180mmhg or diastolic blood pressure > 100mmhg;
8) Patients with unstable angina pectoris or myocardial infarction within the last one month;
9) Severe obesity (BMI > 30kg/m2);
10) Allergic constitution, allergic to the drug components involved in the treatment program;
11) Pregnant or lactating women;
12) patients who are participating in other clinical trials;
13) patients with enrollment complexity or poor compliance, which will affect the evaluation of effect and safety.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Borg score;Number of squats in 30 seconds;2019-nCoV nucleic acid test;Chest CT scan;WHO-5 score;GAD-7 score;Individual symptoms;

Secondary Outcome Measures

Name	Time	Method
tongue change;Immunoinflammatory index;Pulmonary function test;