Acute Exacerbation of Chronic Obstructive Pulmonary DiseaseNCT07393685
Effectiveness of Xuanfei Jiangzhuo Decoction for Influenza-Induced AECOPD
An observational study of Acute Exacerbation of Chronic Obstructive Pulmonary Disease and Influenza, Human, run by Tianjin Medical University at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Acute Exacerbation of Chronic Obstructive Pulmonary Disease, Influenza, Human, Virus Diseases
- What is being tested?
- Xuanfei Jiangzhuo Decoction and Standard Antiviral Therapy (Oseltamivir or Baloxavir marboxil)
- Type of treatment
- Pill or oral medicine
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2026to 31 May 2028
- How long will I take part?
- 28 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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..
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300052
Baoshan Liu, PhD, +86 15532388243, jiacy0605@tmu.edu.cn
Caiyan Jia, jcy19990506@163.com
About this study
Official title: 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).
Read more
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.
- Conditions
- Acute Exacerbation of Chronic Obstructive Pulmonary Disease, Influenza, Human, Virus Diseases
- Being tested
- Xuanfei Jiangzhuo Decoction, Standard Antiviral Therapy (Oseltamivir or Baloxavir marboxil)
- Keywords
- COPD Exacerbation, Real-World Study, Traditional Chinese Medicine
- Medical subject headings
- Influenza, Human, Virus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xuanfei Jiangzhuo DecoctionDrug
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.
Standard Antiviral Therapy (Oseltamivir or Baloxavir marboxil)Drug
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Xuanfei Jiangzhuo Decoction; Drug: Standard Antiviral Therapy (Oseltamivir or Baloxavir marboxil) | |
| 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. Receives: Drug: Standard Antiviral Therapy (Oseltamivir or Baloxavir marboxil) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From baseline (Day 0) up to Day 28
Secondary outcomes (6)
Time to Defervescence
Defined as the time until axillary temperature is ≤ 37.4°C and maintained for 24 hours.
Measured: From baseline (Day 0) up to Day 14
Time to Alleviation of Individual Symptoms
Defined as the time until individual symptom scores are ≤ 1 and maintained for 24 hours.
Measured: From baseline (Day 0) up to Day 28
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.
Measured: Baseline (Day 0), Day 5, Day 14, and Day 28
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.
Measured: From baseline (Day 0) through Day 28
Frequency of Rescue Medication Use
Frequency of additional antipyretic or analgesic use during the study period.
Measured: Up to Day 28
Time to Next AECOPD Event
Time from enrollment to the next confirmed acute exacerbation of COPD.
Measured: Up to Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2026
- Study start1 Aug 2026 (estimated)
- Primary completion31 Mar 2028 (estimated)
- Study completion31 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Exacerbation of Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 28 Days
Sponsor and investigators
- Lead sponsor
- Tianjin Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanqi Song, Tianjin Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07393685
- Sponsor's protocol ID
- IRB2025-YX-643-01
- Other IDs
- IRB2025-YX-643-01
- Status last verified
- Mar 2026
- First submitted
- 31 Jan 2026
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Xuanfei Jiangzhuo Decoction on Clinical Remission in Influenza-Induced AECOPD: Study Protocol for a Prospective, Real-World Cohort Study
- ClinicalTrials.gov ID
- NCT07393685
- Acronym / sponsor ID
- IRB2025-YX-643-01
- Conditions
- Acute Exacerbation of Chronic Obstructive Pulmonary Disease, Influenza, Human, Virus Diseases
- Keywords
- COPD Exacerbation, Real-World Study, Traditional Chinese Medicine
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Tianjin Medical UniversityUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 6 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 28 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exposure Group: XFJZD + Western Medicine | – | Drug: Xuanfei Jiangzhuo Decoction, Drug: Standard Antiviral Therapy (Oseltamivir or Baloxavir marboxil)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 | – | Drug: Standard Antiviral Therapy (Oseltamivir or Baloxavir marboxil)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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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..
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Xuanfei Jiangzhuo DecoctionA 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 | Exposure Group: XFJZD + Western Medicine |
| 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 | Drug | Exposure Group: XFJZD + Western Medicine, Non-Exposure Group: Standard Western Medicine |
Primary outcome
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.
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Exacerbation of Chronic Obstructive Pulmonary Disease and Influenza, Human, run by Tianjin Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Caiyan Jia (15532388243, jcy19990506@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Clinical Remission of AECOPD (time frame: From baseline (Day 0) up to Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2026.