Stable Chronic Obstructive Pulmonary Disease
Conditions
Interventions
Shenxiaoningqi therapy group:Conventional treatment + Shenxiao Ningqi Decoction: Conventional treatment is in accordance with the recommendations of the Guidelines for Diagnosis and Treatment of Chron
Control group:Conventional treatment + placebo: According to the recommendations of the Guidelines for Diagnosis and Treatment of Chronic Obstructive Pulmonary Disease (GOLD 2024), for the treatment o
patients in group E were given flutimavir inhalation powder spray (GSK Gram, national drug approval number H20190055, specifications: 100/62.5/25µg), one inhalation per day. Placebo Chinese medicine (
Shenxiaoningqi therapy group (after crossover):The group of Shenxiaoningqi treatment after a 1-week-washout will crossover into the treatment of conventional treatment + placebo for 1 week (According
Sponsors
China Academy of Chinese Medical Sciences, Guang’anmen Hospital
Eligibility
Sex/Gender
All
Age
40 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Those who meet the diagnostic criteria for chronic obstructive pulmonary disease; (2) Those who meet the TCM syndrome differentiation criteria of lung and kidney deficiency type; (3) Comply with the stable stage of chronic obstructive pulmonary disease, and the GOLD severity classification is 2-3, and the symptom level and acute exacerbation risk group belong to any group A, B, or E; (4) Those who meet the symptoms of chronic obstructive pulmonary disease accompanied by fatigue and whose FSS score is >36 points. (5) Aged between 40 and 75 years old, regardless of gender; (6) Those who voluntarily accept treatment and sign an informed consent form.
Exclusion criteria
Exclusion criteria: (1) Those suffering from serious cardiopulmonary disease, cerebrovascular disease, chronic wasting disease, high risk of sudden death and other diseases who need timely treatment; (2) Those with peptic ulcer or malabsorption; (3) Pregnant or lactating women and women who plan to become pregnant during the study period; (4) Those who are allergic to test drugs; (5) Patients with mental disorders who are unable to cooperate with this study, or patients with epilepsy whose condition is unstable; (6) Patients with serious diseases of other systems (circulatory, respiratory, urinary, hematopoietic system, etc.); (7) There are other people who are not suitable to be observers in drug trials, or who are unable to cooperate with treatment and have difficulty making an accurate evaluation of the effectiveness and safety of the drug; (8) Other situations that the researcher believes are not suitable for inclusion. Those who meet any of the above criteria will be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Manchester Chronic Obstructive Pulmonary Disease (COPD) Fatigue Scale, MCFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| 6 minute walking test, 6MWT;Blood testostorone;Blood Lactic Acid;Blood urea nitrogen; | — |
Countries
China
Contacts
Public ContactGuangxi Li
China Academy of Chinese Medical Sciences, Guang’anmen Hospital
Outcome results
None listed