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Efficacy and Mechanism of Bronchial Asthma with Guben Qushi Granules based on combination of disease and syndrom

Efficacy and Mechanism of Bronchial Asthma with Guben Qushi Granules based on combination of disease and syndrom

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400084492
Enrollment
Unknown
Registered
2024-05-17
Start date
2024-05-31
Completion date
Unknown
Last updated
2024-05-21

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

Conditions

Bronchial Asthma

Interventions

middle dosage experimental group:Medium dose administration of Guben Qushi granules
low dosage experimental group:Low dose administration of Guben Qushi granules
control group:Guben Qushi Placebo Granules

Sponsors

Guangdong Provincial Hospital of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1)Patients who are aged 18–75 years, no gender limitation; (2)Patients who meet the diagnostic criteria of bronchial asthma in a chronic persistent phase with a severity rating of mild to moderate persistence; (3)Asthma Control Test (ACT) scores =19 for uncontrolled asthma; (4)Patients who meet the TCM syndrome of Qi deficiency with Cold Dampness pattern; (5)Patients who sign the written informed consent form.

Exclusion criteria

Exclusion criteria: (1) Patients with severe asthma; (2) Patients with acute or severe asthma within the last 1 month; (3) Patients with respiratory diseases such as chronic obstructive pulmonary disease, bronchiectasis, interstitial lung disease, and active tuberculosis; (4) Patients with severe or uncontrollable underlying diseases: hepatic insufficiency (ALT or AST = 2 ULN, total bilirubin = 2 ULN), renal insufficiency (serum creatinine > 177 µmol/L or 2 mg/dL), NYHA class III-IV; immunodeficiency, such as malignant tumors, organ or bone marrow transplantation, HIV infection, or taking immunosuppressive agents in the past 3 months; (5) Patients who are unwilling to accept obsevation or unable to co-operate due to mental illness; (6) Patients who are unable to complete pulmonary function tests; (7) Patients who are allergic to the test drug; (8) Pregnant or planning pregnancy, or lactating women; (9) Patients receiving allergen specific immunotherapy or biologically targeted drugs (such as omalizumab, duplizumab, etc.); (10) Patients who are participating in or preparing to participate in other clinical trials during the study period; (11) Subjects with poor compliance and difficulty in completing or complying with the requirements of this trial.

Design outcomes

Primary

MeasureTime frame
Scores of Asthma Control Test ;

Secondary

MeasureTime frame
Good Control Rate of Asthma;Asthma Control Questionnaire;Mini Asthma Quality of Life Questionnaire ;Cough and Sputum Assessment Questionnaire ;Grading of Asthma Control Level;Dampness Syndrome Scale of Chinese medicine;Syndrome Score Scale of Chinese medicine;Pre-diastolic FEV1 and FVC change values;Acute asthma attacks;Rate of asthma treatment failure;Emergency usage and frequency of SABA;

Countries

China

Contacts

Public ContactLin Lin

Guangdong Provincial Hospital of Chinese Medicine

drlinlin620@163.com+86 139 0300 2015

Outcome results

None listed

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