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The purpose of this study is to evaluate the efficacy of Si-Ni-Tang (a Chinese Herbal Formula documented in Shang Han Lun) in treating severe sepsis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Si-Ni-Tang (a Chinese Herbal Formula) | Experimental | Treatment for severe sepsis adheres to the International guidelines for management of sepsis and septic shock 2012 and the Surviving Sepsis Campaign updated bundles in response to new evidence in 2015. Besides, 150ml of Si-Ni-Tang will be given by p.o. or a nasogastric tube once per day for 3 days in the treatment group. |
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| Control | No Intervention | Treatment for severe sepsis adheres to the International guidelines for management of sepsis and septic shock 2012 and the Surviving Sepsis Campaign updated bundles in response to new evidence in 2015. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Si-Ni-Tang | Drug | Treatment adheres to the International guidelines for management of severe sepsis and septic shock( 2012) and the Surviving Sepsis Campaign updated bundles in response to new evidence in 2015 for both the treatment group and the control group. In addition, 150ml of Si-Ni-Tang will be given by p.o. or by a nasogastric tube once a day for 3 days in the treatment group. |
| Measure | Description | Time Frame |
|---|---|---|
| 28-day all-cause mortality rates | 28 days all-cause mortality rates after enrollment | 28 days after enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Human leukocyte antigen DR (HLA-DR) expression on cluster of differentiation (CD) 14 T lymphocytes | HLA-DR expression on cluster of differentiation (CD) 14 T lymphocytes measured on day 0 and 3 after enrollment | day 0 and 3after enrollment |
| CD 4+/ CD 8+ ratio |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fang Lai, Master | Guangdong Provincial Hospital of Traditional Chinese Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangdong Provincial Hospital of Chinese Medicine | Guangzhou | Guangdong | 510145 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31462310 | Derived | Zeng R, Zheng Y, Fan R, Zhou G, Zhang Y, Mai S, Xie D, Weng Y, Du J, Han Y, Lai F. Si-ni-tang (a Chinese herbal formula) for improving immunofunction in sepsis: study protocol for a pilot randomized controlled trial. Trials. 2019 Aug 28;20(1):537. doi: 10.1186/s13063-019-3646-3. |
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| ID | Term |
|---|---|
| D018805 | Sepsis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| C478756 | sini tang |
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CD 4+/ CD 8+ ratio measured on day 0 and 3 after enrollment |
| day 0 and 3after enrollment |
| procalcitonin (PCT) | PCT measured on day 0 and 3 after enrollment | day 0 and 3 after enrollment |
| Sequential Organ Failure Assessment (SOFA) score | SOFA score measured on day 0 and 3 after enrollment | day 0 and 3 after enrollment |
| D013568 |
| Pathological Conditions, Signs and Symptoms |