Effectiveness of Xuanfei Jiangzhuo Decoction for Influenza-Induced AECOPD
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Xuanfei Jiangzhuo Decoction, Standard Antiviral Therapy (Oseltamivir or Baloxavir marboxil).
- Who it may be relevant to
- Registry conditions: Acute Exacerbation of Chronic Obstructive Pulmonary Disease, Influenza, Human, Virus Diseases. Basic parameters: from 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effect of Xuanfei Jiangzhuo Decoction on Clinical Remission in Influenza-Induced AECOPD: Study Protocol for a Prospective, Real-World Cohort Study
Overview
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.
Interventions
- Drug Xuanfei Jiangzhuo Decoction
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. - Drug Standard Antiviral Therapy (Oseltamivir or Baloxavir marboxil)
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 outcome measures
- Time to Clinical Remission of AECOPD [Time frame: From baseline (Day 0) up to Day 28]
Secondary outcome measures (6)
- Time to Defervescence [Time frame: From baseline (Day 0) up to Day 14]
- Time to Alleviation of Individual Symptoms [Time frame: From baseline (Day 0) up to Day 28]
- Change in COPD Assessment Test (CAT) Score [Time frame: Baseline (Day 0), Day 5, Day 14, and Day 28]
- Rate of Secondary Bacterial Infection [Time frame: From baseline (Day 0) through Day 28]
- Frequency of Rescue Medication Use [Time frame: Up to Day 28]
- Time to Next AECOPD Event [Time frame: Up to Day 28]
Eligibility criteria
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Tianjin Medical University General Hospital — Tianjin
Identifiers
NCT: NCT07393685 · IRB2025-YX-643-01 · IRB2025-YX-643-01