exacerbations of chronic obstructive pulmonary disease(ECOPD)
Conditions
Interventions
Control group:Standard background therapy (SBT) (oxygen therapy, antibiotics, bronchodilators, expectorants, hormones, noninvasive ventilation, etc.)
Test group (MJFF+FSN group):MJFF combined with FSN therapy+Standard background therapy (oxygen therapy, antibiotics, bronchodilators, expectorants, hormones, noninvasive ventilation, etc.)
Sponsors
GuiZhou University of traditiongal Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 88 Years
Inclusion criteria
Inclusion criteria: Protocol waivers or exemptions for recruitment and enrolment criteria are not allowed.The investigator keeps a screening log to document participant details and confirm eligibility or note reasons for screening failure. Participants with COPD are eligible for enrolment only if they meet all of the following criteria during screening: [1] have given written informed consent that was approved by the Ethical Review Board (ERB) responsible for overseeing the research site. [2] are male or female individuals aged between 18 and 88 years at the time of initial screening. [3] have had a diagnosis of COPD established at least 1 months prior to enrolment confirmed by clinical and spirometric criteria. Note: The clinical characteristics of COPD include dyspnea; recurrent wheezing; chronic cough; frequent lower respiratory tract infections and a history of tobacco smoking among other factors. The spirometric criterion for confirming the presence of non-fully reversible airflow obstruction is a post-bronchodilator FEV1/FVC ratio of less than 0.7. Abbreviations: FEV1=forced expiratory volume in first second; FVC=forced vital capacity. [4] have exacerbations of COPD (ECOPD) as defined by increased dyspnea and/or cough and sputum that worsens in 8.0 g/dL (>80 g/L) for females [7b] Chemistry: serum creatinine=1.5×ULN alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =2×ULN
Exclusion criteria
Exclusion criteria: Participants will be excluded from study enrolment if they meet any of the following criteria within the screening period: [1] Who have extremely severe conditions of ECOPD necessitating invasive mechanical ventilation and/or admission to a medical intensive care unit. [2] exhibit an unstable or uncontrolled medical condition encompassing but not limited to cerebrocardiovascular respiratory (excluding ECOPD e.g. pulmonary embolism) gastrointestinal (e.g. upper gastrointestinal hemorrhage) hepatic renal endocrine or neurological disorders which could potentially compromise participant safety within the study or confound the assessment of efficacy. [3] hematologic disorders characterized by hemorrhagic manifestations including hemophilia leukemia lymphoma and thrombocytopenia among others. [4] have a history of or current evidence for lung cancer or other serious malignancies. [5] have evidence of active pulmonary tuberculosis. [6] have human immunodeficiency virus/acquired immune deficiency syndrome (HIV/AIDS). [7] exhibit a significant uncontrolled neuropsychiatric disorder or are deemed to be at risk of suicide as assessed by the investigator. [8] have a current or past history of alcohol dependence and/or illicit drug abuse within the past year. [9] exhibit an abnormal 12-lead electrocardiogram (ECG) which according to the assessment of the investigator or sponsor heightens the risks associated with study participation. [10] have a known hypersensitivity to any component of MJFF. [11] have been treated with other traditional Chinese herbal medicinal products and/or acupuncture during the screening period. [12] are currently enrolled in any other clinical trial involving an investigational product or any other type of medical research assessed not to be scientifically or medically compatible with this study. [13] are unwilling or unable to complete the study procedures (e.g. severe intellectual or cognitive impairment). [14] are deemed unsuitable for inclusion in the study by the investigator or sponsor due to any factors that may compromise participant safety or confound the interpretation of data.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Auscultatory response-composite; | — |
Secondary
| Measure | Time frame |
|---|---|
| mMRC clinical remission;Dyspnea remission;Auscultation remission;Auscultation response;Crackles remission;SpO2 improvement (response);Corticosteroid-free mMRC clinical remission;Crackles response;Dyspnea response;Clinical PRO remission;Clinical Patient-Reported Outcome (PRO) response;Wheezing remission;Cough-sputum response;Cough-sputum remission;Wheezing response; | — |
Countries
China
Contacts
Public ContactZhenghuan Li
GuiZhou University of traditiongal Chinese Medicine
Outcome results
None listed