Clinical efficacy of TCM syndrome differentiation in the treatment of severe/critical type of novel coronavirus pneumonia (COVID-19): a prospective, observational, one-arm clinical study
- Conditions
- ovel Coronavirus Pneumonia (COVID-19)
- Registration Number
- ITMCTR2000003153
- Lead Sponsor
- Hospital of Chengdu University of Traditional Chinese Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
1. Patients with severe and critical COVID-19 diagnosed in accordance with the Novel Coronavirus infected Pneumonia Diagnosis and Treatment Plan (Trial Version 6);
2. Aged >=18 years, both men and women;
3. Agree to participate in this test and sign the informed consent.
1. Those who cannot receive Chinese medicine treatment;
2. Patients with allergies to certain traditional Chinese medicine decoctions or traditional Chinese medicine injections;
3. Cases where complete diagnosis and treatment information cannot be obtained;
4. Any other chronic respiratory diseases, respiratory bacterial infections such as purulent tonsillitis, acute tracheobronchitis, sinusitis, otitis media, and other respiratory diseases affecting clinical trial evaluation;
5. Accompanied by basic diseases such as severe primary immunodeficiency disease, acquired immunodeficiency syndrome, congenital respiratory malformation, congenital heart disease, and abnormal lung development;
6. Expected survival time is less than 1 week.
Note: Anyone who meets any of the above exclusion criteria cannot be included in this test.
Study & Design
- Study Type
- Observational study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method the ratio of patients transforming from severe/critical to light;fatality rate;Non-invasive/invasive mechanical ventilation time;
- Secondary Outcome Measures
Name Time Method c reactive protein;Creatine Kinase Isoenzyme;Acute physiological and chronic health scores;Nucleic acid detection of novel coronavirus;troponin;arterial blood gas analysis;blood routine examination;ICU hospitalization days + total days in hospital;myohemoglobin;Modified sequential organ failure estimation score;D - dimer;erythrocyte sedimentation rate;procalcitonin;CT Scan-Chest;