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NCT02777606 Clinical Trial

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

Severe Sepsis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02777606
Other study ID # 2014A020212280
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 2016
Est. completion date April 2019

Study information
Verified date September 2023
Source Guangdong Provincial Hospital of Traditional Chinese Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date April 2019
Est. primary completion date December 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Si-Ni-Tang
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.

Locations
Country Name City State
China Guangdong Provincial Hospital of Chinese Medicine Guangzhou Guangdong

Sponsors (1)
Lead Sponsor Collaborator
Guangdong Provincial Hospital of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary 28-day all-cause mortality rates 28 days all-cause mortality rates after enrollment 28 days after enrollment
Secondary 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
Secondary CD 4+/ CD 8+ ratio CD 4+/ CD 8+ ratio measured on day 0 and 3 after enrollment day 0 and 3after enrollment
Secondary procalcitonin (PCT) PCT measured on day 0 and 3 after enrollment day 0 and 3 after enrollment
Secondary Sequential Organ Failure Assessment (SOFA) score SOFA score measured on day 0 and 3 after enrollment day 0 and 3 after enrollment
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