A real world study for traditional Chinese Medicine in the treatment of novel coronavirus pneumonia (COVID-19)

Not Applicable

• Conditions: novel coronavirus pneumonia (COVID-19)

• Registration Number: ITMCTR2000002977
• Lead Sponsor: Shanghai Public Health Clinical Center

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: Pending
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Suspected case:
Patients in observation period of traditional Chinese medicine who are in line with the diagnostic criteria for suspected cases of pneumonia caused by 2019 novel coronavirus infection in the diagnosis and treatment plan for pneumonia caused by 2019 novel coronavirus infection (trial version IV), formulated by the National Health Commission, and in accordance with the diagnosis and treatment plan for pneumonia caused by 2019 nove coronavirus infection in Shanghai (Trial Implementation),formulated by the office of the leading group for the prevention and control of pneumonia caused by 2019 novel coronavirus infection in Shanghai,.
Any one with epidemiological history and any two with clinical manifestations.
(1) Epidemiological history
1) Within 14 days before the onset of the disease, there was a travel history or residential history in Wuhan or other areas where the local cases continued to spread;
2) Within 14 days before the onset of the disease, the patient had been exposed to fever or respiratory symptoms from Wuhan city or other areas where local cases continue to spread;
3) There is a clustering disease or an epidemiological association with the new coronavirus infection.
(2) Clinical manifestations:
1) Fever;
2) It has the imaging characteristics of pneumonia: in the early stage, there are multiple small spot shadow and interstitial changes, especially in the extrapulmonary zone. In severe cases, lung consolidation and pleural effusion are rare;
3) In the early stage of the disease, the total number of leukocytes was normal or decreased, or the lymphocyte count was decreased.

Exclusion Criteria

Patients who have mental confusion, pregnant or lactating women, who with a history of drug abuse or dependence, who allergic to study medication, who have participated in another clinical trial within 3 months,or who have other conditions not suitable for clinical study.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Time of nucleic acid test turning negative;Time for body temperature recovery;Chest CT absorption;

Secondary Outcome Measures

Name	Time	Method
Routine blood test;blood glucose;Blood gas analysis;Biochemical Indicators;routine urine test;cytokine;TCM Syndrome Scale;adverse event;C-reactive protein;Fecal routine;Heart enzyme index;