ITMCTR2200006859尚未招募4 期
A randomized controlled study to evaluate the efficacy and safety of Fufang Yinhua detoxification granules in COVID-19 infection
Yixing People's Hospital0 个研究点开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional study
入排标准
- 年龄范围
- 18 至 —（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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.
研究者
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