Effectiveness of Xuanfei Jiangzhuo Decoction for Influenza-Induced AECOPD: A Prospective Cohort Study

Tianjin Medical University

Status: Begins enrollment in 1 month

Conditions: Influenza, Human; Virus Diseases; Acute Exacerbation of Chronic Obstructive Pulmonary Disease

Treatments: Drug: Standard Antiviral Therapy (Oseltamivir or Baloxavir marboxil); Drug: Xuanfei Jiangzhuo Decoction

Study type: Observational

Funder types: Other

Identifiers

NCT07393685

IRB2025-YX-643-01 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosed with COPD and currently in an acute exacerbation phase according to the Guidelines for the Diagnosis and Treatment of COPD (2021 Revision).
• Confirmed influenza virus infection (Type A or B) via rapid antigen test or PCR within 48 hours of onset.
• Aged 60 years or older.
• Voluntarily participate and provide written informed consent.
• Eligible for pharmacotherapy (able to take TCM combined with Western medicine or Western medicine alone).

Exclusion criteria

• Known allergy or hypersensitivity to any component of the study medications (XFJZD or standard Western antiviral agents).
• 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).

Trial design

300 participants in 2 patient groups

Exposure Group: XFJZD + Western Medicine

Description:

Patients diagnosed with influenza-induced AECOPD who choose to receive Xuanfei Jiangzhuo Decoction (XFJZD) combined with standard Western medicine based on personal preference and physician recommendations. XFJZD is administered orally as a liquid decoction, 200 mL per dose, twice daily for 5 days. They also receive standard antiviral therapy (Oseltamivir or Baloxavir marboxil) and routine COPD maintenance therapy.

Treatment:

Drug: Xuanfei Jiangzhuo Decoction

Drug: Standard Antiviral Therapy (Oseltamivir or Baloxavir marboxil)

Non-Exposure Group: Standard Western Medicine

Description:

Patients diagnosed with influenza-induced AECOPD who choose to receive standard Western medicine alone based on personal preference. This includes standard antiviral therapy (Oseltamivir or Baloxavir marboxil) and routine maintenance therapy for COPD (e.g., ICS/LABA/LAMA, theophylline, roflumilast). This group does not receive the XFJZD intervention.

Treatment:

Drug: Standard Antiviral Therapy (Oseltamivir or Baloxavir marboxil)