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A randomized, open-label, blank-controlled, multi-center clinical study for Lian-Hua Qing-Ke Tablets in the treatment of COVID-19 patients with mild and common-type

A randomized, open-label, blank-controlled, multi-center clinical study for Lian-Hua Qing-Ke Tablets in the treatment of COVID-19 patients with mild and common-type

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100042069
Enrollment
Unknown
Registered
2021-01-12
Start date
2021-01-01
Completion date
Unknown
Last updated
2022-01-18

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

Hebei Province Chest Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Patients with confirmed COVID-19 by Pathogen testing; 2. Above 18 years old (inclusive); 3. At the time of enrollment, the patient had any of the main symptoms (fever, cough, expectoration, chest tightness, polypnea, dyspnea); 4. Voluntarily sign written informed consent.

Exclusion criteria

Exclusion criteria: 1. There is clear evidence of bacterial infection in respiratory tract infections caused by basic diseases such as primary immunodeficiency disease, acquired immunodeficiency syndrome, congenital respiratory malformations, congenital heart disease, gastroesophageal reflux disease, and abnormal lung development; 2. Subjects with the following conditions: asthma requiring daily treatment, any other chronic respiratory disease, respiratory bacterial infections such as purulent tonsillitis, acute tracheobronchitis, sinusitis, otitis media, and other respiratory tracts diseases that affecting clinical trial evaluation. Chest CT confirmed that patients with basic pulmonary diseases such as severe pulmonary interstitial lesions and bronchiectasis; 3. Severe pneumonia requires mechanical ventilation; 4. In the opinion of the investigator, previous or present illnesses may affect patients' participation in the trial or influence the outcome of the study, including: malignant disease, autoimmune disease, liver and kidney disease, blood disease, neurological disease, and endocrine Disease; currently suffering from diseases that seriously affect the immune system, such as: human immunodeficiency virus (HIV) infection, or the blood system, or splenectomy, organ transplantation, etc.; 5. Pregnant or lactating women; 6. Patients who participated in other clinical trials within the last 3 months; 7. An allergic condition, such as a history of allergies to two or more drugs or foods, or a known allergy to the ingredients of the drug; 8. The investigator believes that there are any factors that are not suitable for enrollment or affect the evaluation of the efficacy.

Design outcomes

Primary

MeasureTime frame
Clinical symptoms (fever, cough,expectoration,chest tightness, polypnea, dyspnea) recovery rate and recovery time;

Secondary

MeasureTime frame
Single symptom disappearance rate and main symptom disappearance time;Changes in color, quality and quantity of sputum in patients with expectoration;Changes in oxygenation index (OI);Proportion of aggravation during treatment (in line with the definition of severe or critical illness in the treatment scheme);Rate of CT improvement;Disease recovery rate;Time and rate of coronavirus become negative;

Countries

China

Contacts

Public ContactLiu Qingquan/Jiang Rongmeng/Yan Xixin/Mei Jianqiang/Wu Shucai

Hebei Province Chest Hospital

shucaiwu2009@163.com+86 18633873766

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 13, 2026