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To evaluate the clinical efficacy and immune regulation of Lianhua Qingwen Capsule in patients infected with novel coronavirus

To evaluate the clinical efficacy and immune regulation of Lianhua Qingwen Capsule in patients infected with novel coronavirus

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200065718
Enrollment
Unknown
Registered
2022-11-13
Start date
2022-11-14
Completion date
Unknown
Last updated
2023-05-15

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

Lianhua Qingwen Group:symptomatic treatment+Lianhua Qingwen capsule (4 capsules/time, 3 times/day)10 days of treatment
Control Group:symptomatic treatment

Sponsors

Hebei Yiling Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-70 years. 2. According to the Diagnosis and Treatment Plan for Novel Coronavirus Pneumonia (9th Edition) formulated by the National Health Commission, the first positive time of nucleic acid in subjects with mild and ordinary novel coronavirus pneumonia should not exceed 48 hours from screening. 3. Subjects understood and accepted the process and restrictions of this study, voluntarily participated in this clinical study, and signed a written informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients who took Xiyanping, Redu’ning, Tanreqing, Jinhua Qinggan, Radix isatidis and other Chinese herbal preparations with antiviral effects and/or immunomodulators, or drugs with immunomodulatory effects for external use within 1 week before inclusion; 2. As determined by the researchers, patients with the following severe chronic systemic diseases affected the efficacy evaluation and disease outcome: (1) Poorly controlled diabetes mellitus (random blood glucose >= 11.1mmol/L within 7 days before enrollment, or HBA1c >=8% within the last 3 months under standard hypoglycemic treatment); (2) Poorly controlled hypertension (systolic blood pressure >=140mmH or diastolic blood pressure >=90mmHg under the standard use of antihypertensive drugs); (3) Chronic lung diseases, including moderate to severe COPD(chronic obstructive pulmonary disease), asthma, pulmonary interstitial diseases, cystic fibrosis, and pulmonary hypertension); (4) Tumors, serious cardiovascular and cerebrovascular diseases (heart failure, cardiomyopathy, dementia, mental disorders, etc.), diseases that seriously affect the immune system, etc.; (5) Chronic kidney disease (including chronic kidney disease stage 3-5), chronic liver disease (such as liver fibrosis, cirrhosis, or serum AST and/or ALT>=3 times the upper limit of normal); (6) Severe obesity: BMI>=35 kg/m^2; 3. Suffering from diseases that seriously affect the immune system, such as human immunodeficiency virus (HIV) infection, or the blood system, or splenectomy or organ transplantation; 4. Previous or current medical conditions that the investigator has determined may affect the patient's outcome in the trial or study include: malignancies, autoimmune diseases, liver and kidney disorders, hematologic disorders, neurological disorders, and endocrine disorders; Or psychiatric conditions that may affect programme compliance; 5. Those who have a history of alcohol or illicit drug abuse, or who took or used alcohol during the study period; 6. Serological examination (HBsAg, anti-HCV, anti-HIV or TPA-AB) with positive results; 7. Those who have a history of drug dependence, drug abuse or test positive for addictive substances during screening within 12 months; 8. Patients known to be allergic to Lianhua Qingwen ingredients or products, or allergic constitution (including allergic reaction to other drugs); 9. Have other factors that the researcher thinks are not suitable to participate in this study; 10. Heavy smokers and chronic respiratory diseases; 11. Patients during pregnancy and lactation.

Design outcomes

Primary

MeasureTime frame
Median time for main symptoms to achieve continuous remission;

Secondary

MeasureTime frame
Median time for onset and recovery of fever;Proportion of patients with major symptoms relieved;Proportion of patients with all clinical symptoms relieved;Time and rate of nucleic acid turning negative;Incidence of COVID-19 related severe and critical diseases;Incidence of COVID-19 related deaths and all-cause deaths;

Countries

China

Contacts

Public ContactJia Zhenhua

Hebei Yiling Hospital

jiatcm@163.com+86 18503210608

Outcome results

None listed

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