COVID-19
Conditions
Interventions
trial arm:Fufang Yinhua detoxification granules
control arm:Lianhua Qingwen granules
Sponsors
Yixing People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) Clinically diagnosed with COVID-19 classificated according to the Diagnosis and Treatment Protocol for COVID-19 (Trial Version 9 formulated by the National Health Commission; 2) SARS-CoV-2 nucleic acid test is positive; 3) Age =18 years old; 4) Infected subjects with clinical symptoms (fever, cough, sore throat, fatigue, etc.) or abnormal of hematology; 5) Subjects fully understand and participate this trial voluntarily, and sign Informed Consent Form.
Exclusion criteria
Exclusion criteria: 1) Subjects who have used drugs with pharmacological or clinical effects against novel coronavirus or traditional Chinese medicine containing similar ingredients to the study drug within 5 days prior to screening, including but not limited to Jinhua Qinggan, Lianhua Qingwen, Radix isatidis, Paxlovid, Azifudine, etc.; 2) Subjects receiving COVID-19 monoclonal antibodies, convalescent plasma, or other concomitant drugs within 28 days prior to screening; 3) Subjects who had SARS-CoV-2 vaccination within 28 days prior to screening or who planned to vaccinateSARS-CoV-2 during the visit and follow-up period; 4) Immunodeficient subjects (such as patients with malignant tumors, organ or bone marrow transplants, AIDS patients, long-term use of corticosteroids or other immunosuppressive drugs resulting in immune dysfunction); 5) Subjects with serious cardiovascular and cerebrovascular diseases, chronic pulmonary diseases (chronic obstructive pulmonary disease, moderate to severe asthma, interstitial pulmonary disease), inadequately controlleddiabetes, tumor and other underlying diseases; 6) Subjects who are allergic to the ingredients contained in the study drug, or subjects are in allergic constitution; 7) Medicalhistory of gastrointestinal diseases that affect drug absorption (including but not limited to reflux esophagitis, chronic diarrhea, inflammatory bowel disease, intestinal tuberculosis, gastrinoma, short bowel syndrome, post-subtotal gastrectomy, etc.); 8) Women in the lactation or pregnancy period; 9) Suspected or confirmed history of alcohol, drug abuse or mental illness; 10) Subjects who participated in other clinical trials of drugs within 1 month before screening; 11) Any other factor that the investigator considered unsuitable for participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time between initial administration and recovery of clinical symptoms (e.g. fever, cough, sore throat, fatigue, etc.); | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes of blood routine before and after administration;Proportion of subjects who progressed to normal, severe or critical COVID-19;Time between initial administration and nucleic acid turning negative for the first time; | — |
Countries
China
Contacts
Public ContactGuangming Zhou
Outcome results
None listed