Skip to content

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

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

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2100004294
Enrollment
Unknown
Registered
2020-05-02
Start date
2020-05-02
Completion date
Unknown
Last updated
2023-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Novel Coronavirus Pneumonia (COVID-19)

Interventions

Sponsors

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

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion 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

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.

Design outcomes

Primary

MeasureTime frame
St George's respiratory questionnaire score;Six minute walking experiment;Fatigue assessment scale;

Countries

China

Contacts

Public ContactNanshan Zhong, Jian Wang

Guangzhou Medical University

jiw037@ucsd.edu+86 020 37103055

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026