Evaluating Xuanfei Baidu Granule for treating acute COPD exacerbations

A Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Study on the Efficacy and Safety of Xuanfei Baidu Granule in the Treatment of Acute Exacerbation of Chronic Obstructive Pulmonary Disease

This study is testing if a new herbal treatment called Xuanfei Baidu granule can help people with COPD feel better during sudden flare-ups.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 375 (estimated)
• Ages: 40 Years to 80 Years
• Sex: All
• Sponsor: Peking University People's Hospital (other)
• Locations: 1 site (Beijing)
• Trial ID: NCT06134063 on ClinicalTrials.gov

What this trial studies

This clinical study is a prospective, multicenter, randomized, double-blind, placebo-controlled trial aimed at assessing the efficacy and safety of Xuanfei Baidu granule in patients experiencing acute exacerbations of chronic obstructive pulmonary disease (COPD). A total of 375 participants will be enrolled and randomly assigned to receive either the active treatment or a placebo for 7 days, alongside their standard care. Participants will be monitored through follow-up visits on days 7, 14, and 21, with additional data collected if hospitalization occurs due to exacerbation. The study aims to determine the impact of the granule on symptom relief and hospitalization rates.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 40 to 80 with a history of COPD and experiencing mild to moderate acute exacerbations.

Not a fit: Patients with severe respiratory diseases or those requiring hospitalization prior to the study will not benefit from this trial.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients suffering from acute exacerbations of COPD.

How similar studies have performed: While this approach is novel, similar studies have shown promise in evaluating herbal treatments for respiratory conditions.

Eligibility criteria

Inclusion Criteria:

* Aged between 40 and 80 years old, including 40 and 80 years old, regardless of gender;
* Clinical records of traceable of the chronic obstructive pulmonary disease history records, after bronchodilator FEV1 less than 80% of the expected value;
* Comply with the definition of COPD acute exacerbations and with mild and moderate severity assessment;
* Symptoms of AECOPD time less than 48 h;
* "Shiduyufei" diagnostic standard;
* Volunteered for the study, signed informed consent, is willing to cooperate with the visitor.

Exclusion Criteria:

* Patients showing signs of hospitalization;
* With respiratory system diseases other than the AECOPD (for example, pneumonia, bronchiectasis, active tuberculosis, pneumothorax, pleural effusion, pulmonary embolism, or affect the respiratory movement function of neuromuscular diseases, etc.);
* Patients with severe basic diseases (for example, uncontrolled hypertension diabetes and complicated with heart failure (NYHA class IV), severe arrhythmia, acute coronary syndrome, hemodynamic instability, long-term use of immunosuppressive agents, etc.);
* With primary disease such as tumor or blood system;
* With severe liver disease (cirrhosis, portal hypertension, varices bleeding) or renal insufficiency;
* Pregnant women and breastfeeding mothers, those suspected of being pregnant, or women of childbearing age at risk of pregnancy who have not taken effective contraceptive measures;
* Dementia, mental disorders, such as unable to read or understand the research content, the information collection;
* With drug allergy;
* 3 months prior to screening for other interventional clinical research and the research data information;
* Within 1 week before screening been oral Chinese medicine or other proprietary Chinese medicine treatment;
* Patient refused to sign a consent form, or estimate adherence is poor, or follow-up possibilities is poor.

Where this trial is running

Beijing

• Peking University People's Hospital — Beijing, China (RECRUITING)

Study contacts

• Study coordinator: Jingli Feng

Conditions: Acute Exacerbation of Chronic Obstructive Pulmonary Disease, Xuanfei Baidu granule