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| Name | Class |
|---|---|
| Linfen Central Hospital | UNKNOWN |
| Zhuhai Hospital of Integrated Traditional Chinese and Western Medicine | OTHER |
| Qingyang hospital of traditional Chinese medicine, Gansu Province | UNKNOWN |
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This study adopted a multi-center, randomized, controlled trial design. Patients with acute exacerbation of chronic obstructive pulmonary disease who met the inclusion criteria were randomly assigned to the experimental group and the control group. Both groups were treated under the guidance of the "Expert consensus on the acute exacerbation of chronic obstructive pulmonary disease in China (revision in 2023)" and the GOLD guidelines. The experimental group was treated with modified Maxing Shigan Decoction. The modified Ma Xing Shi Gan Decoction was administered twice a day for 14 days. Taking the length of hospital stay (days) of the patients as the primary efficacy indicator, and the TCM syndrome score, dyspnea score (mMRC), 6-minute walk test and mechanical ventilation demand rate as the secondary efficacy indicators, the clinical efficacy of modified Maxing Shigan Decoction in the treatment of acute exacerbation of chronic obstructive pulmonary disease was evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| test group | Experimental | The patient was given basic Western medical treatment combined with modified Ma Xing Shi Gan Decoction, orally twice a day for 14 days of intervention. |
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| control group | Active Comparator | Under the guidance of the "Expert consensus on the acute exacerbation of chronic obstructive pulmonary disease in China (revision in 2023)" and the GOLD guidelines, basic Western medical treatment was given |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| modified Ma Xing Shi Gan Decoction | Drug | The patient was given basic Western medical treatment combined with modified Ma Xing Shi Gan Decoction, orally twice a day for 14 days of intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| Length of Hospital Stay (days) | Number of days the patient remains hospitalized during the study period. | collected at baseline, 7 days, and 14 days post-treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Traditional Chinese Medicine symptom score | The Traditional Chinese Medicine Syndrome Rating Scale is divided into four severity levels: absent, mild, moderate, and severe. Primary symptoms include cough, sputum volume, sputum characteristics, chest fullness and oppression, and dyspnea. Scores range from 0 (least severe) to 6 (most severe). Secondary symptoms include fever, restlessness, thirst with desire to drink, and urinary and bowel status. Scores range from 0 to 3 based on severity. The sum of these scores constitutes the total score. A higher total score indicates greater severity. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cuiling Feng | Contact | 010-88325882 | fengcuiling@sina.com |
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have not decided
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| Traditional Chinese Medicine Hospital of Changji Hui Autonomous Prefecture, Xinjiang | UNKNOWN |
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| The specific drug comes from "Chinese Expert Consensus on the Diagnosis and Treatment of Acute Exacerbation of Chronic Obstructive Pulmonary Disease (Revised Edition 2023)" and the GOLD guidelines | Drug | Under the guidance of the "Expert consensus on the acute exacerbation of chronic obstructive pulmonary disease in China (revision in 2023)" and the GOLD guidelines, basic Western medical treatment was given. The main types include third-generation cephalosporins, expectorants, short-acting anticholinergic drugs, and short-acting β2 receptor agonists, etc. |
|
| collected at baseline, 7 days, and 14 days post-treatment |
| Dyspnea assessment | mMRC questionnaire | collected at baseline, 7 days, and 14 days post-treatment. |
| Mechanical Ventilation Requirement Rate | Data is collected in real-time via the hospital's Electronic Medical Record (EMR) system and the ICU ventilator recording system to calculate Total Mechanical Ventilation Time (TMVT). This is further analyzed to distinguish Invasive Mechanical Ventilation Time (IMVT) and Non-Invasive Mechanical Ventilation Time (NIMVT). | collected at baseline, 7 days, and 14 days post-treatment. |
| 6-Minute Walk Test Distance | Measured at baseline, 7 days, and 14 days. |
| Complete blood count (CBC) | Collected at baseline, 7 days, and 14 days. |
| C-reactive protein (CRP) | collected at baseline, 7 days, and 14 days post-treatment. |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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