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A randomized multicenter positive drug-parallel controlled clinical trial of the efficacy and safety of Qiguanyan Pill in the treatment of acute bronchitis (including acute exacerbation of chronic bronchitis) (with syndrome of phlegm-dampness accumulated in the lung)

A randomized multicenter positive drug-parallel controlled clinical trial of the efficacy and safety of Qiguanyan Pill in the treatment of acute bronchitis (including acute exacerbation of chronic bronchitis) (with syndrome of phlegm-dampness accumulated in the lung)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025000076
Enrollment
Unknown
Registered
2025-01-12
Start date
2024-10-31
Completion date
Unknown
Last updated
2025-02-03

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

Conditions

acute bronchitis (including acute exacerbation of chronic bronchitis)

Interventions

Control group:Guaifenesin and dextromethorphan hydrobromide capsules oral administration
Experimental group:Qiguanyan Pill oral administration

Sponsors

Beijing University of Chinese Medicine Third Affiliated Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Compatible with the diagnosis of acute bronchitis or acute exacerbation of chronic bronchitis; (2) Compatible with the TCM diagnosis of phlegm-dampness accumulated in the lung; (3) Age 18-75 years old (including 18 years old and 75 years old) gender is not limited; (4) Voluntarily participate in this clinical trial give informed consent and sign the informed consent form.

Exclusion criteria

Exclusion criteria: (1)Patient with other diseases that present with symptoms like cough and sputum such as tuberculosis pneumonia bronchial asthma interstitial lung disease lung malignancy gastroesophageal reflux disease etc.; (2) Taking antibiotics cough and phlegm medicines and other herbal and chemical medicines that have an impact on the study within 1 week; (3) Renal function Cr greater than the upper limit of the reference value or liver function ALT AST > 1.5 times the upper limit of the reference value; (4) Patients with severe primary diseases such as heart brain liver kidney respiratory mental and hematologic diseases for example severe hypertension insomnia etc.; (5) Pregnant or lactating women or women who are planning to give birth within the last 3 months; (6) Allergy to two or more drugs or foods or allergy to the test drug (including positive drugs) or its components or excipients; (7) Mental retardation or psychiatric disorder; (8) Participation in other clinical trials within one month; (9) Patients who in the opinion of the investigator are not suitable to participate in this clinical trial.

Design outcomes

Primary

MeasureTime frame
Cough Evaluation Test;Sputum symptom composite score;

Secondary

MeasureTime frame
Urinalysis;TCM syndrome healing effects;Cough disappearance time/virtually disappearance time;Bronchitis Severity Score;Between-group differences in antibiotic use;Wheezing Symptom Score;

Countries

China

Contacts

Public ContactWang Chengxiang

Beijing University of Chinese Medicine Third Affiliated Hospital

wang601@vip.sina.com+86 137 0139 5341

Outcome results

None listed

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