Ignite Creation Date:
2024-05-06 @ 9:15 AM
Last Modification Date:
2024-10-26 @ 12:12 PM
Study NCT ID:
NCT02937974
Status:
UNKNOWN
Last Update Posted:
2016-10-19
First Post:
2016-10-13
Brief Title:
Evaluate the Efficacy of Xuebijing Injection in Acute Exacerbations of COPD
Sponsor:
Chinese PLA General Hospital
Organization:
Chinese PLA General Hospital
Study Overview
Official Title:
Evaluate the Efficacy of Xuebijing Injection in Acute Exacerbations of COPDa Multicentre Randomised Controlled Trial
Status:
UNKNOWN
Status Verified Date:
2016-10
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Objective A prospective multicenter randomized controlled trial to assess the efficacy and safety of Xuebijing injection for acute exacerbation of chronic obstructive pulmonary diseaseAECOPD
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 groupExperimental Xuebijing injection 50ml in 100ml of Normal Saline IV in 80mins per 12 hours administration of the agent for consecutive 5 daysPlacebo 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 cellTh1Th2HLA-DRCRPPCTIL-4IL-6IL-10TNF-αIFN-γ APACHEⅡ CAPS score
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 groupExperimental Xuebijing injection 50ml in 100ml of Normal Saline IV in 80mins per 12 hours administration of the agent for consecutive 5 daysPlacebo 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 cellTh1Th2HLA-DRCRPPCTIL-4IL-6IL-10TNF-αIFN-γ APACHEⅡ CAPS score
Detailed Description:
A prospective multicenter randomized controlled trial to assess the efficacy and safety of Xuebijing injection for acute exacerbation of chronic obstructive pulmonary diseaseAECOPD
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Chinese PLA General Hospital | OTHER | Chinese PLA General Hospital | None |