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

Not Applicable

Completed

• Conditions: Severe Sepsis
• Interventions: Drug: Si-Ni-Tang

• Registration Number: NCT02777606
• Lead Sponsor: Guangdong Provincial Hospital of Traditional Chinese Medicine

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-05-14
• Study First Submitted QC: 2016-05-18
• Study First Posted: 2016-05-19
• Study Start: 2016-06
• Primary Completion: 2018-12
• Study Completion: 2019-04
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-11
• Last Update Posted: 2023-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Si-Ni-Tang (a Chinese Herbal Formula)	Si-Ni-Tang	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.

Primary Outcome Measures

Name	Time	Method
28-day all-cause mortality rates	28 days after enrollment	28 days all-cause mortality rates after enrollment

Secondary Outcome Measures

Name	Time	Method
procalcitonin (PCT)	day 0 and 3 after enrollment	PCT measured on day 0 and 3 after enrollment
Human leukocyte antigen DR (HLA-DR) expression on cluster of differentiation (CD) 14 T lymphocytes	day 0 and 3after enrollment	HLA-DR expression on cluster of differentiation (CD) 14 T lymphocytes measured on day 0 and 3 after enrollment
CD 4+/ CD 8+ ratio	day 0 and 3after enrollment	CD 4+/ CD 8+ ratio measured on day 0 and 3 after enrollment
Sequential Organ Failure Assessment (SOFA) score	day 0 and 3 after enrollment	SOFA score measured on day 0 and 3 after enrollment

Trial Locations

Locations (1)

Guangdong Provincial Hospital of Chinese Medicine; 🇨🇳 Guangzhou, Guangdong, China