ITMCTR2000003035招募中4 期
A randomized, open-label, controlled trial for the safety and efficiency of Kesuting syrup and Keqing capsule in the treatment of mild and moderate novel coronavirus pneumonia (COVID-19)
试验速览
- 阶段
- 4 期
- 状态
- 招募中
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 75（—）
- 性别
- All
入选标准
- •1. Patients withmild and moderate novel coronavirus pneumonia (COVID-19) diagnosed refers to the diagnosis and treatment plan for pneumonia with new coronavirus infection (trial version 5);
- •2. Patient cough score > 1;
- •3. Aged 18- 80 years old;
- •4. The subjects (including male subjects) had no pregnancy, sperm donor, egg donor for nearly half a year, and were willing to take effective contraception from the first dose until three months after the last;
- •5. Subjects are fully aware of the purpose, nature, content, process and possible adverse reactions of the study and voluntarily sign the informed consent.
排除标准
- •1. Expected to die within 48 hours;
- •2. Patients with asthma attack, purulent tonsillitis, acute and chronic bronchitis, sinusitis, otitis media, and other respiratory diseases affecting clinical trial evaluation; and chest CT confirmed the existence of severe pulmonary interstitial disease, bronchiectasis, obstructive pulmonary disease With lung disease;
- •3. Patients with respiratory infections caused by basic diseases such as primary immunodeficiency disease, acquired immunodeficiency syndrome, congenital respiratory malformations, congenital heart disease, gastroesophageal reflux disease, and lung development;
- •4. At the discretion of the investigator, previous or present chronic or severe illness may affect participation in the trial or affect the outcome of the study, including but not limited to the gastrointestinal system, cardio-cerebral vascular system, liver, kidney, hematopoietic system, lymph System, endocrine system, immune system, malignant tumor, severe malnutrition, nervous system and endocrine system and other diseases; and currently suffering from human immunodeficiency virus (HIV) infection, splenectomy, organ transplantation and other diseases that seriously affect the immune system By;
- •5. People who cannot co-operate with mental state, suffer from mental illness, cannot control themselves, and cannot express;
- •6. Patients with poorly controlled hypertension: low pressure >=110 mmHg or high pressure >= 180 mmHg;
- •7. Patients with ALT, AST >= 1.5 times the upper limit of normal value, and Scr> upper limit of normal value;
- •8. People with a specific history of allergies (such as asthma, measles, eczema, etc.), or allergies (such as those allergic to two or more drugs, foods such as milk and pollen), or those who are allergic to the components of cough syrup and cough capsule;
- •9. Patients with a history of drug abuse or dependence within 6 months before randomization;
- •10. Those who have used any Chinese and Western medicine for cough and phlegm elimination within 24 hours before random enrollment;
- •11. Female patients during pregnancy and lactation;
- •12. Patients who have participated or are participating in other drug clinical trials within 3 months before screening;
- •13. Researchers consider others unsuitable to participate in this clinical trial.
研究者
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