Effectiveness of Xuanfei Jiangzhuo Decoction for Influenza-Induced AECOPD

March 9, 2026 updated by: Yanqi Song, Tianjin Medical University

Effect of Xuanfei Jiangzhuo Decoction on Clinical Remission in Influenza-Induced AECOPD: Study Protocol for a Prospective, Real-World Cohort Study

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300052

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study 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.

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
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
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.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Clinical Remission of AECOPD
Time Frame: 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.
From baseline (Day 0) up to Day 28

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Defervescence
Time Frame: From baseline (Day 0) up to Day 14
Defined as the time until axillary temperature is ≤ 37.4°C and maintained for 24 hours.
From baseline (Day 0) up to Day 14
Time to Alleviation of Individual Symptoms
Time Frame: From baseline (Day 0) up to Day 28
Defined as the time until individual symptom scores are ≤ 1 and maintained for 24 hours.
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
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.
Baseline (Day 0), Day 5, Day 14, and Day 28
Rate of Secondary Bacterial Infection
Time Frame: From baseline (Day 0) through Day 28
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.
From baseline (Day 0) through Day 28
Frequency of Rescue Medication Use
Time Frame: Up to Day 28
Frequency of additional antipyretic or analgesic use during the study period.
Up to Day 28
Time to Next AECOPD Event
Time Frame: Up to Day 28
Time from enrollment to the next confirmed acute exacerbation of COPD.
Up to Day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tianjin Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2026

Primary Completion (Estimated)

March 31, 2028

Study Completion (Estimated)

May 31, 2028

Study Registration Dates

First Submitted

January 31, 2026

First Submitted That Met QC Criteria

January 31, 2026

First Posted (Actual)

February 6, 2026

Study Record Updates

Last Update Posted (Actual)

March 12, 2026

Last Update Submitted That Met QC Criteria

March 9, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB2025-YX-643-01 (Other Grant/Funding Number: Tianjin Medical University General Hospital)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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