Effectiveness of Xuanfei Jiangzhuo Decoction for Influenza-Induced AECOPD

NCT07393685 · tracked via the Priya Life Science China tracker

Sponsor

Tianjin Medical University

Phase

Observational

Started

2026-08-01

Last updated

2026-03-12

Condition(s) studied

Acute Exacerbation of Chronic Obstructive Pulmonary DiseaseInfluenza, HumanVirus Diseases

Investigational drug(s) / intervention(s)

Xuanfei Jiangzhuo DecoctionStandard Antiviral Therapy (Oseltamivir or Baloxavir marboxil) →

Xuanfei Jiangzhuo Decoction: A traditional Chinese medicine composite formula derived from Maxing Shigan Tang and Shengjiang San. It is administered orally as a liquid decoction, 200 mL per dose, twice daily (morning and evening, 30 minutes after meals) for 5 days.

Standard Antiviral Therapy (Oseltamivir or Baloxavir marboxil): Patients receive standard antiviral treatment according to clinical guidelines and physician judgment. Medications include Oseltamivir (e.g., 75 mg twice daily for 5 days) or Baloxavir marboxil (singl

Study summary

The goal of this observational study is to learn if a traditional Chinese herbal medicine (Xuanfei Jiangzhuo Decoction) works to help older adults recover from a COPD flare-up caused by the flu (influenza virus). The main questions it aims to answer are:

Does the herbal medicine help participants feel better and recover faster? Does it lower the chance of getting a second infection from bacteria? Is the herbal medicine safe to use? Researchers will compare participants who choose to take the herbal medicine along with their standard flu treatment (Oseltamivir or Baloxavir) to participants who only take the standard flu treatment (Oseltamivir or Baloxavir).

Participants will:

Take the herbal medicine (a liquid drink) twice a day for 5 days, or just take their standard flu medicine for 5 days.

Visit the clinic 4 times over 28 days for checkups and tests. Provide blood and stool samples to help researchers understand how the medicine affects the body and gut health.

Answer simple questions about their cough, breathing, and energy levels.

Eligibility

Sex

ALL

Min age

60 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Diagnosed with Influenza-induced AECOPD according to the Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease (GOLD 2025) and the Expert Consensus on the Diagnosis and Treatment of AECOPD in China (Updated 2023), confirmed by spirometry and viral testing (antigen or PCR), and excluding pneumonia and heart failure via chest CT and NT-proBNP. * Aged 60 years or older. * Voluntarily participate and provide written informed consent.. Exclusion Criteria: * Known allergy or hypersensitivity to any component of the study medications. * Presence of severe bacterial co-infection at enrollment requiring systemic antibiotic therapy. * Severe dysfunction of major organs that may interfere with efficacy or safety assessment (e.g., severe cardiac insufficiency, hepatic impairment, or renal failure). * Participation in other interventional clinical trials within the past 3 months. * Inability to be contacted for follow-up (e.g., lack of permanent address or valid contact information). * Any other condition that, in the opinion of the investigator, would make the patient unsuitable for study participation (e.g., severe cognitive impairment or psychiatric disorders).

Primary outcome measure(s)

Time to Clinical Remission of AECOPD — From baseline (Day 0) up to Day 28
Defined as the duration from treatment initiation (Day 0) to the point where the mMRC dyspnea scale score returns to pre-exacerbation baseline, and both cough and dyspnea symptom scores (0-3 Likert scale) decrease by at least 1 point from the peak and remain at that reduced level for ≥ 48 hours.

Trial sites (1)

Facility	City	Region	Status
Tianjin Medical University General Hospital	Tianjin	Tianjin Municipality

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07393685 on ClinicalTrials.gov ↗ ← All trials in China