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

Guangdong Provincial Hospital of Traditional Chinese Medicine50 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Severe Sepsis

Interventions

Si-Ni-TangDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (1)

Guangdong Provincial Hospital of Chinese Medicine

Guangzhou, Guangdong, China

Outcomes

Primary Outcomes

28-day all-cause mortality rates

28 days all-cause mortality rates after enrollment

Time frame: 28 days after enrollment

Secondary Outcomes

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

Time frame: day 0 and 3after enrollment

CD 4+/ CD 8+ ratio

CD 4+/ CD 8+ ratio measured on day 0 and 3 after enrollment

Time frame: day 0 and 3after enrollment

procalcitonin (PCT)

PCT measured on day 0 and 3 after enrollment

Time frame: day 0 and 3 after enrollment

Sequential Organ Failure Assessment (SOFA) score

SOFA score measured on day 0 and 3 after enrollment

Time frame: day 0 and 3 after enrollment

Data from ClinicalTrials.gov

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