Study for the Effectiveness and Safety of Yi-Qi Hua-shi Jie-Du-Fang in the Treatment of the Novel Coronavirus Pneumonia (COVID-19)
- Conditions
- ovel Coronavirus Pneumonia (COVID-19)
- Registration Number
- ITMCTR2000003080
- Lead Sponsor
- Affiliated Hospital of traditional Chinese and Western Medicine Nanjing University of Chinese Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
1) Confirmed or clinically diagnosed patients with the novel coronavirus disease;
2) Those who have been identified by Chinese medicine as pestilence stagnant in Lung;
3) Inpatients aged 18 to 75 years male or female;
4) Volunteer to receive treatment under their own scheme and sign informed consent.
1) Patients with mild, severe or critical novel coronavirus disease;
2) According to the researcher's judgment, previous or current diseases may affect patients' participation in the trial or influence the outcome of the study, including: malignant disease, autoimmune disease, severe malnutrition, liver and kidney disease, blood disease, nervous system Diseases and endocrine diseases; currently suffering from diseases that seriously affect the immune system, such as: human immunodeficiency virus (HIV) infection, or the blood system, or splenectomy, organ transplantation, etc .;
3) Those who are allergic to the research drug and its main ingredients;
4) pregnant or lactating women;
5) Those who have difficulty taking medicine orally.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method lasting time of fever;lasting time of novel coronavirus pneumonia virus nucleic acid detected by RT-PCR and negative result rate of the novel coronavirus disease nucleic acid;
- Secondary Outcome Measures
Name Time Method Comparison of changes in SpO2, oxygen saturation, lymphocyte count comparison;Comparison of conversion rates of severe (severe or critical) subjects in each group;Clinical recovery time: the body temperature returned to normal and lasting for more than 3 days, the respiratory symptoms improved significantly, and the test result was negative for two consecutive times(ended at the time of the first negative result);Comparison of TCM symptom score (degree of fever, cough, sputum, chest tightness, shortness of breath, anorexia, abdominal distension, the tongue proper and the tongue coating, pulse condition);Comparison of changes in inflammation indicators (white blood cell count, C-reactive protein, ESR, procalcitonin) before and after treatment;