The Efficacy of Si-Ni-Tang (a Chinese Herbal Formula) for Severe Sepsis

Study Overview
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Brief Summary
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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.

Conditions
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Severe Sepsis

Intervention / Treatment
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* Drug: Si-Ni-Tang


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Severe sepsis (according to American college of chest Physicians/ Society of Critical Care Medicine (ACCP/SCCM) criteria) Informed consent provided by patients or legally authorized representative Yin syndrome in syndrome differentiation (according to principles of traditional Chinese medicine (TCM) syndrome differentiation) Exclusion Criteria: Pregnant or nursing female Subject receiving immunosuppressive or immunoenhancement therapy in the past 3 months Patients with known or suspicious autoimmune diseases Patients not expected to survive 28 days due to end-stage disease or other uncorrectable medical condition Fasting subjects Known or suspicious allergy to any ingredient of Si-Ni-Tang Patients not expected to survive 5 days for various reasons

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Si-Ni-Tang (a Chinese Herbal Formula)<br>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. | Drug: Si-Ni-Tang<br>* 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.<br>* Other names: Sini decoction;|
| No Intervention: Control<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 28-day all-cause mortality rates | 28 days all-cause mortality rates after enrollment | 28 days after enrollment | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Severe Sepsis, Sini Decoction, Immune Function, Mortality