Effectiveness of Xuanfei Jiangzhuo Decoction for Influenza-Induced AECOPD
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age60+
SponsorTianjin Medical University
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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..
Disqualifiers
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.
Trial population
Patients aged 60 years or older presenting with influenza-induced Acute Exacerbation of Chronic Obstructive Pulmonary Disease (AECOPD) at the Department of Traditional Chinese Medicine and the Department of Infectious Diseases at Tianjin Medical University General Hospital.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Xuanfei Jiangzhuo Decoction
DrugA 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)
DrugPatients 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
Treatment groups
300 Participants
are divided into 2 treatment groupsGroup A: Exposure Group: XFJZD + Western Medicine2 interventions
Group B: Non-Exposure Group: Standard Western Medicine1 intervention
Trial outcomes
Primary outcomes
1
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 28Secondary outcomes
1
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 142
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 283
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 284
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 28Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: