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A multicenter randomized double-blind placebo-controlled clinical study on the efficacy and safety of Lianhua Qingke tablets in the treatment of acute bronchitis

A multicenter randomized double-blind placebo-controlled clinical study on the efficacy and safety of Lianhua Qingke tablets in the treatment of acute bronchitis

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2024000321
Enrollment
Unknown
Registered
2024-08-29
Start date
2024-09-05
Completion date
Unknown
Last updated
2024-09-16

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

Conditions

acute tracheobronchitis

Interventions

Test group:Lianhua Qingke Tablets 4 tablets/time 3 times/day for a total of 7 days
control group:Lianhua Qingke Tablets placebo 4 tablets/time 3 times/day for a total of 7 days

Sponsors

First Affiliated Hospital of Guangzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Age between 18-75 years old; 2. Diagnosed as acute bronchitis: characterized by cough and/or sputum as the main symptoms with a duration of less than 3 days and a course of less than 21 days and without accompanied by runny nose headache or overall muscle soreness; 3. Bronchitis Severity Score (BSS) = 5 points; 4. The subjects voluntarily accept the drug treatment and sign an informed consent form.

Exclusion criteria

Exclusion criteria: 1. History of chronic cough; 2. Underarm temperature>37.3 ?; There are significant abnormalities in chest radiographs (or CT scans) taken within 3.7 days; 4. Patients with other respiratory system diseases that may cause coughing such as chronic obstructive pulmonary disease bronchiectasis asthma lung cancer tuberculosis pneumonia lung abscess gastroesophageal reflux disease sinusitis etc; 5. Liver or kidney dysfunction (alanine aminotransferase (ALT) aspartate aminotransferase (AST) and alkaline phosphatase (ALP) = 3.0 × ULN blood creatinine (Cr)>2.0 × ULN total bilirubin (TBIL) urea nitrogen (BUN)/urea (UREA)>2.0 × ULN); 6. Patients with severe primary diseases such as heart liver kidney digestive and hematopoietic systems or psychiatric disorders; 7. Individuals who are allergic to the experimental drug; 8. Pregnant lactating and women preparing to conceive; 9. Participants in clinical trials of other drugs within the past 30 days; 10. Other situations that the researcher deems unsuitable for participation in the experiment.

Design outcomes

Primary

MeasureTime frame
the change in bronchitis severity score (BSS) compared to baseline;

Secondary

MeasureTime frame
Change rate of bronchitis severity score (BSS) compared to baseline;Change value and rate of change in cough severity score (CET) compared to baseline;The change values and rates of individual symptoms (cough sputum dyspnea chest pain during coughing and rales (auscultation)) compared to baseline;Time and rate of disappearance of cough;Change value and rate of change in cough visual analogue scale (VAS) compared to baseline;

Countries

China

Contacts

Public ContactKefang Lai

First Affiliated Hospital of Guangzhou Medical University

klai@vip.163.com18232100862

Outcome results

None listed

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