ITMCTR2100004294招募中1 期
A randomized, double-blind, controlled trial for Bufei Huoxue Capsule in the treatment of convalescent COVID-19 patients
State Key Laboratory of Respiratory Disease, Guangzhou Institute of Respiratory Diseases, the First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China0 个研究点开始时间: 待定最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 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 80（—）
- 性别
- All
入选标准
- •1. Aged >= 18 years, male or female.
- •2. Patients who were diagnosed as COVID-19 according to the The Diagnosis and Treatment Scheme of COVID-19(The 7th Trial Edition).
- •3. The condition meets the discharge standards stipulated in the The Diagnosis and Treatment Scheme of COVID-19(The 7th Trial Edition) after treatment.
- •4. The syndrome differentiations are the deficiency of lung and spleen qi at the time of screening. According to the diagnostic criteria of the The Diagnosis and Treatment Scheme of COVID-19 (The 7th Trial Edition).
- •5. The patient or his/her guardian agrees to participate in the study and provides written, informed consent for participation.
排除标准
- •1. Known or suspected allergy to the components of BFHX.
- •2. Acute infections, along with other viruses or bacteria.
- •3. Abnormal liver and kidney function tests (ALT, AST, SCr >= 1.5 times the upper limit of normal).
- •4. Participating in other drug clinical trials.
- •5. Pregnant and lactating women; or those who cannot take effective contraceptive measures during the trial period.
- •6. Along with severe liver disease (such as liver tumors, various types of hepatitis, etc.) or a history of drug-induced liver injury or drugs that are currently used/ expected to use potential liver damage during the study (immunosuppressive agents such as cyclosporine, tacrolimus, etc.; anti-tuberculosis drugs such as rifampicin, isoniazid, etc.; chemotherapy drugs such as cyclophosphamide, methotrexate, azathioprine, etc. and patients with liver damage restorative materials such as polygonum multiflorum, tusanqi, tripterygium wilfordii).
- •7. Any other circumstances under which the investigator considers the patient to be unsuitable for participation in the study.
研究者
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