A randomized, double-blind, controlled trial for Bufei Huoxue Capsule in the treatment of convalescent COVID-19 patients

Phase 1

Recruiting

Conditions: ovel Coronavirus Pneumonia (COVID-19)

Registration Number: ITMCTR2100004294

Lead Sponsor: State Key Laboratory of Respiratory Disease, Guangzhou Institute of Respiratory Diseases, the First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: Not specified

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.