Effect of Xuanfei Jiangzhuo Decoction on Clinical Remission in Influenza-Induced AECOPD: Study Protocol for a Prospective, Real-World Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Time to Clinical Remission of AECOPD
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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..
排除标准
- •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).
研究组 & 干预措施
Exposure Group: XFJZD + Western Medicine
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.
干预措施: Standard Antiviral Therapy (Oseltamivir or Baloxavir marboxil) (Drug)
Exposure Group: XFJZD + Western Medicine
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.
干预措施: Xuanfei Jiangzhuo Decoction (Drug)
Non-Exposure Group: Standard Western Medicine
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.
干预措施: Standard Antiviral Therapy (Oseltamivir or Baloxavir marboxil) (Drug)
结局指标
主要结局
Time to Clinical Remission of AECOPD
时间窗: 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.
次要结局
- Time to Defervescence(From baseline (Day 0) up to Day 14)
- Time to Alleviation of Individual Symptoms(From baseline (Day 0) up to Day 28)
- Change in COPD Assessment Test (CAT) Score(Baseline (Day 0), Day 5, Day 14, and Day 28)
- Rate of Secondary Bacterial Infection(From baseline (Day 0) through Day 28)
- Frequency of Rescue Medication Use(Up to Day 28)
- Time to Next AECOPD Event(Up to Day 28)
研究者
Yanqi Song
Attending Physician
Tianjin Medical University