Effectiveness of Xuanfei Jiangzhuo Decoction for Influenza-Induced AECOPD
Effect of Xuanfei Jiangzhuo Decoction on Clinical Remission in Influenza-Induced AECOPD: Study Protocol for a Prospective, Real-World Cohort Study
1 other identifier
observational
300
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2026
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 31, 2026
CompletedFirst Posted
Study publicly available on registry
February 6, 2026
CompletedStudy Start
First participant enrolled
August 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2028
Study Completion
Last participant's last visit for all outcomes
May 31, 2028
March 12, 2026
March 1, 2026
1.7 years
January 31, 2026
March 9, 2026
Conditions
Keywords
Outcome Measures
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.
From baseline (Day 0) up to Day 28
Secondary Outcomes (6)
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
- +1 more secondary outcomes
Study Arms (2)
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.
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.
Interventions
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
Eligibility Criteria
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.
You may qualify if:
- 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..
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300052, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 28 Days
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Attending Physician
Study Record Dates
First Submitted
January 31, 2026
First Posted
February 6, 2026
Study Start (Estimated)
August 1, 2026
Primary Completion (Estimated)
March 31, 2028
Study Completion (Estimated)
May 31, 2028
Last Updated
March 12, 2026
Record last verified: 2026-03