ITMCTR2200006859
Not yet recruiting
Phase 4
A randomized controlled study to evaluate the efficacy and safety of Fufang Yinhua detoxification granules in COVID-19 infection
Yixing People's Hospital0 sitesTBD
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Yixing People's Hospital
- Status
- Not yet recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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;
Outcomes
Primary Outcomes
Not specified
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