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A randomized, double-blind, placebo-controlled, multicenter clinical trial to evaluate the efficacy and safety of Bailing capsule in the treatment of stable chronic obstructive pulmonary disease with the frequency of AECOPD as the main efficacy index

A randomized, double-blind, placebo-controlled, multicenter clinical trial to evaluate the efficacy and safety of Bailing capsule in the treatment of stable chronic obstructive pulmonary disease with the frequency of AECOPD as the main efficacy index

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400081575
Enrollment
Unknown
Registered
2024-03-05
Start date
2024-03-13
Completion date
Unknown
Last updated
2024-03-11

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

Conditions

Stable chronic obstructive pulmonary disease

Interventions

Experimental group:Western medicine basic treatment + Bailing capsule
Control group:Western medicine basic treatment + Bailing capsule simulator

Sponsors

West China Hospital of Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Consistent with the Western medicine diagnosis of chronic obstructive pulmonary disease, and in the clinical stable stage of chronic obstructive pulmonary disease; (2) accompanied by wheezing, fatigue and waist and knee pain symptoms; (3) The severity of airflow restriction in chronic obstructive pulmonary disease was GOLD grade 2 to 4; (4) The GOLD ABE assessment was in group E (=2 moderate acute exacerbations or 1 acute exacerbation leading to hospital admission within the past 1 year); (5) Age 40-75 (inclusive) years old, gender is not limited; (6) Agree to participate in the study and sign the informed consent.

Exclusion criteria

Exclusion criteria: (1) Patients with asthma, active tuberculosis, lung cancer, bronchiectasis, pulmonary embolism, pulmonary heart disease, pulmonary interstitial disease, bronchiolitis obliterans, diffuse panbronchiolitis or other active pulmonary diseases; (2) There were patients with AECOPD or infection within 4 weeks prior to enrollment; (3) Patients who need long-term oxygen therapy (daily oxygen inhalation time =12h) or are receiving pulmonary rehabilitation treatment; (4) Patients who had previously undergone pulmonary resection or underwent lung volume reduction surgery within 12 months before screening; (5) Patients with serious primary diseases of the heart, brain, liver, kidney and blood system, such as malignant tumors, heart failure, severe arrhythmia, and poorly controlled diabetes; (6) Patients with abnormal renal function Scr exceeding 1.5 times the upper limit of the reference value, or abnormal hepatic function AST and ALT exceeding 2 times the upper limit of the reference value; (7) Known or suspected history of alcohol or drug abuse; (8) Pregnant or lactating women or those planning to become pregnant during the study period; (9) Allergic to the ingredients of the study drug; (10) Participants in other clinical trials within the last 3 months; (11) Participants determined by the investigator to be unsuitable for participation in this clinical trial.

Design outcomes

Primary

MeasureTime frame
Number of AECOPD episodes;Main symptoms of chronic obstructive pulmonary disease/TCM syndrome score;

Secondary

MeasureTime frame
First onset of AECOPD during the trial period (days);BCSS score;CAT score;mMRC score;Lung function indicators (FEV1, FVC, FEV1/FVC);The occurrence of clinically important indicators of deterioration (CID);

Countries

China

Contacts

Public ContactWen Fuqiang

West China Hospital of Sichuan University

wenfuqiang@126.com+86 189 8060 1258

Outcome results

None listed

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