ITMCTR2100004294
Recruiting
Phase 1
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 sitesTBD
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- State Key Laboratory of Respiratory Disease, Guangzhou Institute of Respiratory Diseases, the First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Not specified
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