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A multicenter, randomized, controlled clinical trial of efficacy and safety of xinan Guben Peiyuan formula series in the treatment of COPD

A multicenter, randomized, controlled clinical trial of efficacy and safety of xinan Guben Peiyuan formula series in the treatment of COPD

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2200005834
Enrollment
Unknown
Registered
2022-04-09
Start date
2022-04-01
Completion date
Unknown
Last updated
2023-02-20

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

Conditions

Chronic obstructive pulmonary disease

Interventions

Treatment group 2:Tiotropium Bromide Powder for Inhalation+Shen Qi Bu Zhong prescription
Control group 1:Tiotropium Bromide Powder for Inhalation
Treatment group 3:Tiotropium Bromide Powder for Inhalation+Shen Qi Tiao Shen prescription
Control group 3: Tiotropium Bromide Powder for Inhalation
Treatment group 1:Tiotropium Bromide Powder for Inhalation+Shen Qi Wen Fei prescription
Control group 2:Tiotropium Bromide Powder for Inhalation

Sponsors

The First Affiliated Hospital of Anhui University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 75 Years

Inclusion criteria

Inclusion criteria: ? Patients who meet the diagnostic criteria for COPD; ? It belongs to stable period; ? It conforms to the TCM syndrome differentiation standard of lung qi deficiency/Lung spleen qi deficiency/lung kidney qi deficiency; ?40 years = age =75 years; ? Did not participate in other clinical studies 3 month before enrollment; ? No antibiotics were used 3 month before enrollment; ? Voluntarily accept treatment, sign informed consent before the test, and fully understand the content, process and possible adverse reactions of the test.

Exclusion criteria

Exclusion criteria: If the answer to any of the following questions is "yes", the patient will not be admitted to the study: ? Allergic constitution or allergic to the known ingredients of the test drug or control drug; ? Extremely severe COPD patients and acute stage patients; ? Pregnant and lactation women; ? Delirious, dementia, all kinds of mental patients; ? Functional grade ? and hemodynamic instability; ? With bronchiectasis, bronchial asthma, active pulmonary tuberculosis, pulmonary embolism, pneumothorax, pleural effusion, malignant tumor and other neuromuscular diseases affecting respiratory motor function;? Severe liver and kidney disease (severe liver disease refers to cirrhosis, portal hypertension and varicose bleeding, serious kidney disease including dialysis, kidney transplantation); ? all kinds of reasons for long-term bed. ? Persons who have participated in other interventional clinical trials within the last 3 months; ? Participants considered unsuitable for the clinical trial by the investigator.

Design outcomes

Primary

MeasureTime frame
Lung function;Acute aggravation severity;Number of acute exacerbations;TCM syndrome integral;Number of colds;

Secondary

MeasureTime frame
Dyspnea classification;SF-36 scale;COPD - PRO scale;Self-rating Depression Scale;Self-rating Anxiety Scale;The CAT score;Six minutes' walk;

Countries

China

Contacts

Public ContactLi Zegeng

Anhui University of Chinese Medicine

li6609@126.com13805516609

Outcome results

None listed

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