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A randomized, controlled, single center clinical study on the intervention effect and mechanism of Lianhua Qingke tablet on patients with severe pneumonia

A randomized, controlled, single center clinical study on the intervention effect and mechanism of Lianhua Qingke tablet on patients with severe pneumonia

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300067998
Enrollment
Unknown
Registered
2023-02-02
Start date
2023-02-03
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

Severe pneumonia?AECOPD

Interventions

Low dose group:Base treatment+Lianhua Qingke Tablets, 4 tablets/time, 3 times/day
High dose group:Base treatment+Lianhua Qingke Tablets, 8 tablets/time, 3 times/day
Control group:Base treatment

Sponsors

The Second Hospital of Hebei Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Met diagnostic criteria for severe pneumonia; 2.18 years <= age <= 80 years; 3. Acute onset of severe community-acquired pneumonia or chronic obstructive pulmonary disease according to the source of infection and different etiological classification; 4. Diagnosis of severe pneumonia within 48h; 5. The patient or family members were aware of the content of the study and voluntarily signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Those with severe cardiac dysfunction and hepatic and renal failure; 2. Patient expected survival less than 14 days due to underlying disease, such as poor control of malignancy, cardiac arrest within 30 days prior, etc; 3. Patients with serious mental illness; 4. Those who are pregnant or preparing for pregnancy, or are unable to take effective measures of contraception; 5. Allergy to the active ingredients of the test drug or to their excipients; 6. Had participated in a clinical intervention trial within nearly 3 months; 7. Subjects who, in the opinion of the attending physician, would not be eligible for this trial.

Design outcomes

Primary

MeasureTime frame
APACHE II scale score change values and rate of change;

Secondary

MeasureTime frame
Total length of ICU stay;On treatment mortality in patients with severe pneumonia;Degree of chest X-ray changes;Sputum: viscosity analysis of sputum; Extracellular trapping of neutrophils and inflammatory factors;Detection of blood samples: analysis of inflammatory factors, inflammatory cell typing and proportions (macrophages, neutrophils, epithelial cells);Alveolar lavage fluid: inflammatory cell typing and proportions (macrophages, neutrophils, epithelial cells), analysis of inflammatory cytokines, mucin (MUC5AC) content analysis;Stool: 16S sequencing, metagenomic sequencing;Airway mucosa: biopsy forceps were taken for pathological analysis of airway mucosal cell composition and proportion; Tracheal brushings were obtained for epithelial / immune cell typing and cilia length and ciliary beat frequency analysis from ciliated cells;

Countries

China

Contacts

Public ContactYadong Yuan

The Second Hospital of Hebei Medical University

hebeiyyd@126.com+86 131 9184 5064

Outcome results

None listed

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