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| ID | Type | Description | Link |
|---|---|---|---|
| Chinese PLA General Hospital | Other Identifier | Chinese PLA General Hospital |
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| Name | Class |
|---|---|
| First Hospitals affiliated to the China PLA General Hospital | OTHER_GOV |
| Navy General Hospital, Beijing | OTHER |
| Rocket Force General Hospital,Chinese People's Liberation Army | UNKNOWN |
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Objective: A prospective multicenter randomized controlled trial to assess the efficacy and safety of Xuebijing injection for acute exacerbation of chronic obstructive pulmonary disease(AECOPD).
Methods: 254 AECOPD inpatients will be recruited in 6 hospitals in China over 2 years. They will be randomly assigned to Experimental group and Placebo group,Experimental: Xuebijing injection 50ml in 100ml of Normal Saline IV, in 80mins, per 12 hours. administration of the agent for consecutive 5 days;Placebo Comparator: Normal Saline 150ml IV, in 80mins, per 12 hours. administration of the agent for consecutive 5 days. Compare the following index between the two groups: Invasive mechanical ventilation rate, length of hospital stay, Treg cell,Th1,Th2,HLA-DR,CRP,PCT,IL-4,IL-6,IL-10,TNF-α,IFN-γ, APACHEⅡ, CAPS score.
A prospective multicenter randomized controlled trial to assess the efficacy and safety of Xuebijing injection for acute exacerbation of chronic obstructive pulmonary disease(AECOPD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Xuebijing | Experimental | Xuebijing injection 50ml in 100ml of Normal Saline IV, in 80mins, per 12 hours. administration of the agent for consecutive 5 days |
|
| Placebo | Placebo Comparator | Normal Saline 150ml IV, in 80mins, per 12 hours. administration of the agent for consecutive 5 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Xuebijing | Drug | Xuebijing injection 50ml in 100ml of Normal Saline IV, in 80mins, per 12 hours. administration of the agent for consecutive 5 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Invasive mechanical ventilation rate | Invasive mechanical ventilation rate in % | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| length of Hospital stay | Invasive mechanical ventilation rate in days | 28 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lixin Xie, Professor | Chinese PLA General Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chinese PLA General Hospital | Beijing | 100853 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19729666 | Background | Freeman CM, Martinez FJ, Han MK, Ames TM, Chensue SW, Todt JC, Arenberg DA, Meldrum CA, Getty C, McCloskey L, Curtis JL. Lung dendritic cell expression of maturation molecules increases with worsening chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2009 Dec 15;180(12):1179-88. doi: 10.1164/rccm.200904-0552OC. Epub 2009 Sep 3. | |
| 30777117 |
| Label | URL |
|---|---|
| 19729666 | View source |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| C549376 | Xuebijing |
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| 307 Hospital of PLA | OTHER |
| Beijing Shijitan Hospital, Capital Medical University | OTHER |
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| Placebo | Drug | Normal Saline 150ml IV, in 80mins, per 12 hours. administration of the agent for consecutive 5 days |
|
| Xie S, Yan P, Yao C, Yan X, Huo Y, Zhang J, Liu S, Feng Z, Shang H, Xie L. Efficacy and safety of Xuebijing injection and its influence on immunomodulation in acute exacerbations of chronic obstructive pulmonary disease: study protocol for a randomized controlled trial. Trials. 2019 Feb 18;20(1):136. doi: 10.1186/s13063-019-3204-z. |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |