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Effects of Xuanfei Baidu granules in patients with acute exacerbation of a progressive, long-term lung condition

Efficacy of Xuanfei Baidu granules in patients with acute exacerbation of COPD: a randomized, controlled trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN83930526
Enrollment
120
Registered
2026-07-13
Start date
2024-05-01
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Acute Exacerbation of COPD Respiratory

Interventions

The Control Group received standardized comprehensive Western medicine treatment, adhering strictly to GOLD 2026 and domestic AECOPD management standards. This protocol included oxygen therapy to main

Sponsors

Tianjin Binhai New Area Dagang Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Patients aged 40–85 years 2. Confirmed diagnosis of COPD according to GOLD 2026 guidelines, with an acute exacerbation necessitating hospitalization (defined by an acute onset of respiratory symptoms—dyspnea, increased sputum volume, or purulent sputum—exceeding daily variations) 3. GOLD classification 1–4 4. Willingness to provide written informed consent

Exclusion criteria

Exclusion criteria: 1. Respiratory failure requiring invasive mechanical ventilation 2. Concomitant diagnosis of asthma, bronchiectasis, or active pulmonary tuberculosis 3. Severe comorbidities, including unstable cardiovascular disease, malignancy, or end-stage renal/hepatic failure 4. History of severe allergic reaction to the study drug 5. Inability to comply with the 7-day treatment protocol

Design outcomes

Primary

MeasureTime frame
Time to clinical symptom recovery measured using an investigator-conducted clinical assessment (evaluating dyspnea relief, normalised sputum volume, and stable cough status) at randomisation (baseline) and day 14; participants who fail to meet recovery criteria by day 14 will be right-censored at day 14

Countries

China

Contacts

Public ContactShubin Lv
83730692@qq.com+8615022575601

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Aug 10, 2026