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NCT Number: NCT07393685

Effectiveness of Xuanfei Jiangzhuo Decoction for Influenza-Induced AECOPD

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.

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Key information

Conditions

Acute Exacerbation of Chronic Obstructive Pulmonary Disease Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

60 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Xuanfei Jiangzhuo Decoction

Drug

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)

Drug

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

Primary outcomes

  1. Time to Clinical Remission of AECOPD

    Time frame: 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.

Secondary outcomes

  1. Time to Defervescence

    Time frame: From baseline (Day 0) up to Day 14

    Defined as the time until axillary temperature is ≤ 37.4°C and maintained for 24 hours.

  2. Time to Alleviation of Individual Symptoms

    Time frame: From baseline (Day 0) up to Day 28

    Defined as the time until individual symptom scores are ≤ 1 and maintained for 24 hours.

  3. Change in COPD Assessment Test (CAT) Score

    Time frame: Baseline (Day 0), Day 5, Day 14, and Day 28

    The CAT measures the impact of COPD on a person's life. Scores range from 0-40, with higher scores indicating a more severe impact of the disease.

  4. Rate of Secondary Bacterial Infection

    Time frame: From baseline (Day 0) through Day 28

    Defined as clinical worsening (recurrence of fever, increased purulent sputum) accompanied by at least one of: (1) positive sputum culture for a pathogenic bacterium, (2) procalcitonin (PCT) > 0.25 ng/mL, or (3) radiographic evidence of new infiltrates.

  5. Frequency of Rescue Medication Use

    Time frame: Up to Day 28

    Frequency of additional antipyretic or analgesic use during the study period.

  6. Time to Next AECOPD Event

    Time frame: Up to Day 28

    Time from enrollment to the next confirmed acute exacerbation of COPD.

Study contacts

Contact information is provided by the study sponsor or research team.

Caiyan Jia

CONTACT

[email protected]

15532388243

Sponsors and collaborators

Lead sponsor

Tianjin Medical University

Other

Registry information

Official study title

Effect of Xuanfei Jiangzhuo Decoction on Clinical Remission in Influenza-Induced AECOPD: Study Protocol for a Prospective, Real-World Cohort Study

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Feb 6, 2026
Registry last updated
Mar 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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