Skip to content

A randomized controlled multi-center clinical trial of Qingke Pingchuan Granule for the treatment of acute exacerbation period (Phlegm-heat obstructing lung syndrome??) in patients with bronchiectasis

A randomized controlled multi-center clinical trial of Qingke Pingchuan Granule for the treatment of acute exacerbation period (Phlegm-heat obstructing lung syndrome??) in patients with bronchiectasis

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2024000780
Enrollment
Unknown
Registered
2024-12-08
Start date
2024-12-15
Completion date
Unknown
Last updated
2025-01-06

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

Conditions

Acute exacerbation of bronchiectasis

Interventions

Sponsors

Xiyuan Hospital of CACMS
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1)18 years old = age = 80 years old gender is not limited (2)Meets the diagnostic criteria for acute exacerbation of bronchiectasis; (3)Meet the diagnostic criteria of phlegm-heat obstructing lung syndrome in traditional Chinese medicine; (4)Lung function classification between grade II and III (30%=FEV1 accounting for the estimated value < 80%) (5)Voluntarily participate in this clinical trial gave informed consent and signed an informed consent form.

Exclusion criteria

Exclusion criteria: (1)Patients with dry bronchiectasis with hemoptysis as the main manifestation (2)Patients with high fever (greater than 39 degrees) massive hemoptysis or severe respiratory failure requiring ventilator treatment (3)Combined with other serious internal diseases such as malignant tumors serious heart liver and kidney diseases serious metabolic diseases etc. (4)Long-term use of glucocorticoid or immunosuppressive therapy; (5)Gastrointestinal administration is not appropriate; (6)Women during pregnancy lactation and preparation for pregnancy; (7)Allergic to the ingredients of this product; (8)Persons with a mental state that is unable to cooperate with observers or cognitive impairment; (9)Participants who have participated in other drug trials within the past 3 months; (10)The researchers believe that there are any other circumstances that are not suitable for inclusion.

Design outcomes

Primary

MeasureTime frame
The proportion of subjects whose disease reached the effective standard on the 3rd 5th and 7th day of medication;

Secondary

MeasureTime frame
Modified version of the Medical Research Council (mMRC) Dyspnea Questionnaire on the 7th day of medication;Cough and Expectoration Assessment Questionnaire (CASA-Q) on the 7th day of medication;Quality of Life Questionnaire (QOL-B) Score for Bronchiectasis on the 7th day of medication;Antibiotic usage;Peripheral blood inflammatory indicators on the 7th day of medication: white blood cell count (WBC) neutrophil ratio (NEUT%) eosinophilic ratio (EOS%) C-reactive protein (CRP) procalcitonin (PCT);Pathogen detection and exhaled breath electronic nose detection during acute exacerbation of bronchiectasis;Pulmonary function on the 7th day of medication: Forced expiratory volume (FEV1) forced vital capacity (FVC) FEV1/FVC ratio and FEV1 accounted for the estimated value;Time of relief of single clinical symptoms (cough phlegm hemoptysis fever wheezing) after medication;Improvement rate of TCM syndrome points on the 3rd 5th and 7th day of medication;

Countries

China

Contacts

Public ContactQing Miao

Xiyuan Hospital of CACMS

miaoqing55@sina.com13910812309

Outcome results

None listed

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