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Evaluation of the efficacy and safety of Loudan Lifei Granule in the treatment of acute exacerbation of chronic obstructive pulmonary disease

Evaluation of the efficacy and safety of Loudan Lifei Granule in the treatment of acute exacerbation of chronic obstructive pulmonary disease

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400084543
Enrollment
Unknown
Registered
2024-05-20
Start date
2022-05-01
Completion date
Unknown
Last updated
2024-05-27

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

Conditions

Acute exacerbation of chronic obstructive pulmonary disease

Interventions

Test group:Loudan Lifei Granules
control group:Loudan Lifei Granule Placebo

Sponsors

The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Age: 40-75 years old; (2) COPD conforms to the diagnostic criteria of COPD formulated by the Branch of Respiratory Society of Chinese Medical Association; There were reports of pulmonary function diagnosis in the past year, that is, FEV1/FVC<70% after inhalation of bronchodilator, and FEV1 accounted for = 30% of the estimated value; (3) Outpatient visit due to upper respiratory tract infection; (4) URTI symptoms such as sore throat, stuffy nose, runny nose and sneeze or flu such as fever, headache and myalgia in recent 3 days At least two of the toxic symptoms; (5) There is no new wet rale in the lung; (6) No new exudation shadow is found on chest X-ray or lung CT; (7) Imaging examination: It is consistent with chronic bronchitis and emphysema, and no new pulmonary exudation shadow is found. Pulmonary tuberculosis, pulmonary tumor, pulmonary embolism, interstitial pulmonary disease and pulmonary edema were excluded. (Secondary mild bronchiectasis is not excluded); (8) Sign the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Bronchiectasis with hemoptysis, or obvious bronchiectasis on imaging; (2) Patients were complicated with other active lung diseases before enrollment, such as active tuberculosis, lung cancer, pulmonary embolism, sarcoidosis, interstitial lung disease, primary pulmonary hypertension and bronchial asthma; (3) Those who have severe liver and kidney insufficiency, cardiac insufficiency, etc. and need corresponding drug treatment; (4) Subjects with unstable ischemic heart disease, myocardial infarction and cerebrovascular accident within 6 months before enrollment, subjects with acute coronary syndrome or who have undergone percutaneous coronary intervention or coronary artery bypass grafting within 3 months (5) Subjects with psychosis, mental retardation, poor motivation, drug and alcohol abuse or other restrictions on participating in this study; (6) Participated in other clinical trials within 4 weeks before enrollment; (7) Women who are pregnant or breast-feeding or plan to be pregnant during the study period, or women who have fertility but do not use effective contraceptive methods (women of childbearing age should check urine HCG); (8) Those who are allergic to Lou Dan Li Fei granules.

Design outcomes

Primary

MeasureTime frame
EXACT-PRO scale;

Secondary

MeasureTime frame
Acute exacerbation admission rate;TCM syndrome integral;White blood cell count;EOS Count;CRP;Dyspnea score;Pulmonary function level;Th17/Treg related inflammatory factors;CAT score;

Countries

China

Contacts

Public ContactSUN ZENG TAO

The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine

zengtaosun2021@126.com+86 135 1201 8056

Outcome results

None listed

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