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| ID | Type | Description | Link |
|---|---|---|---|
| IRB2025-YX-643-01 | Other Grant/Funding Number | Tianjin Medical University General Hospital |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Xuanfei Jiangzhuo Decoction | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Defervescence | 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 | Defined as the time until individual symptom scores are ≤ 1 and maintained for 24 hours. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Caiyan Jia | Contact | 15532388243 | jcy19990506@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin Medical University General Hospital | Tianjin | Tianjin Municipality | 300052 | China |
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| 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 |
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| 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. | 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. | From baseline (Day 0) through Day 28 |
| Frequency of Rescue Medication Use | Frequency of additional antipyretic or analgesic use during the study period. | Up to Day 28 |
| Time to Next AECOPD Event | Time from enrollment to the next confirmed acute exacerbation of COPD. | Up to Day 28 |
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| D014777 | Virus Diseases |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C000607643 | yifei xuanfei jiangzhuo |
| D053139 | Oseltamivir |
| C000628402 | baloxavir |
| ID | Term |
|---|---|
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D053138 | Cyclohexenes |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
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