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.
Study Type
OBSERVATIONAL
Enrollment
300
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.
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
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China
Time to Clinical Remission of AECOPD
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.
Time frame: From baseline (Day 0) up to Day 28
Time to Defervescence
Defined as the time until axillary temperature is ≤ 37.4°C and maintained for 24 hours.
Time frame: From baseline (Day 0) up to Day 14
Time to Alleviation of Individual Symptoms
Defined as the time until individual symptom scores are ≤ 1 and maintained for 24 hours.
Time frame: From baseline (Day 0) up to Day 28
Change in COPD Assessment Test (CAT) Score
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.
Time frame: Baseline (Day 0), Day 5, Day 14, and Day 28
Rate of Secondary Bacterial Infection
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.
Time frame: From baseline (Day 0) through Day 28
Frequency of Rescue Medication Use
Frequency of additional antipyretic or analgesic use during the study period.
Time frame: Up to Day 28
Time to Next AECOPD Event
Time from enrollment to the next confirmed acute exacerbation of COPD.
Time frame: Up to Day 28
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