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To evaluate the clinical mechanism of Lianhua Qingwen Capsule on the systemic immune regulation of patients with new coronavirus pneumonia

To evaluate the clinical mechanism of Lianhua Qingwen Capsule on the systemic immune regulation of patients with new coronavirus pneumonia

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2100004767
Enrollment
Unknown
Registered
2021-04-20
Start date
2021-04-07
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

Coronavirus diseaseNovel Coronavirus Pneumonia (COVID-19)

Interventions

Basic treatment group:In principle, no drugs and other treatments are used
Lianhua Qingwen Group:Capsules 4 capsules/time, 3 times a day

Sponsors

Shanghai Public Health Clinical Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 59 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 59 years; 2. Refer to the "New Coronavirus Pneumonia Diagnosis and Treatment Plan (Trial Eighth Edition)" formulated by the National Health Commission, with evidence of etiology or serology, and confirmed mild patients with new coronavirus pneumonia (mild clinical symptoms, no imaging Pneumonia manifestations). 3. The weight of male subjects must be >=50 kg, and the weight of female subjects >=45kg; body mass index (BMI=weight (kg)/height (m) square calculation) between 19 and 26 (including cutoff values)); 4. The subject understands and accepts the process and restriction requirements of this study, voluntarily participates in this clinical study, and signs a written informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients who have taken Xiyanping, Reduning, Tanreqing, Jinhua Qinggan, Banlangen and other antiviral Chinese medicines and/or immunomodulators, or drugs with immunomodulatory effects for external use within 1 week before being selected; 2. Currently suffering from diseases that seriously affect the immune system, such as human immunodeficiency virus (HIV) infection, or blood system, or splenectomy, organ transplantation, etc. 3. According to the judgment of the investigator, past or current diseases may affect the patients participation in the trial or the outcome of the study, including: malignant diseases, autoimmune diseases, liver and kidney diseases, hematological diseases, neurological diseases, and endocrine diseases Disease; or mental illness that may affect the compliance of the plan; 4. Patients who have a history of alcohol or banned drug abuse, or have taken or used alcohol products during the research period; 5. Serological examination (HBsAg, anti-HCV, anti-HIV or TPPA-Ab) with positive results; 6. Patients who have a history of drug dependence or drug abuse within 12 months, or those who tested positive for addictive substances during screening; 7. Patients with known allergies to Lianhua Qingwen ingredients or products, or allergies (including allergic reactions to other drugs); 8. Patients who have other factors that the researcher thinks are not suitable for participating in this research.

Design outcomes

Primary

MeasureTime frame
Inflammatory factors;Immune cell genus;

Countries

China

Contacts

Public ContactLu Hongzhou

Shanghai Public Health Clinical Center

luhongzhou@fudan.edu.cn+86 18930810088

Outcome results

None listed

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