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

Primary Purpose

Severe Sepsis

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Si-Ni-Tang
Sponsored by
Guangdong Provincial Hospital of Traditional Chinese Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Severe Sepsis focused on measuring Severe Sepsis, Sini Decoction, Immune Function, Mortality

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Guangdong Provincial Hospital of Chinese Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Si-Ni-Tang (a Chinese Herbal Formula)

Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

28-day all-cause mortality rates
28 days all-cause mortality rates after enrollment

Secondary Outcome Measures

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
CD 4+/ CD 8+ ratio
CD 4+/ CD 8+ ratio measured on day 0 and 3 after enrollment
procalcitonin (PCT)
PCT measured on day 0 and 3 after enrollment
Sequential Organ Failure Assessment (SOFA) score
SOFA score measured on day 0 and 3 after enrollment

Full Information

First Posted
May 14, 2016
Last Updated
September 11, 2023
Sponsor
Guangdong Provincial Hospital of Traditional Chinese Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT02777606
Brief Title
The Efficacy of Si-Ni-Tang (a Chinese Herbal Formula) for Severe Sepsis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
June 2016 (Actual)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
April 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guangdong Provincial Hospital of Traditional Chinese Medicine

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Sepsis
Keywords
Severe Sepsis, Sini Decoction, Immune Function, Mortality

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Si-Ni-Tang (a Chinese Herbal Formula)
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Si-Ni-Tang
Other Intervention Name(s)
Sini decoction
Intervention Description
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.
Primary Outcome Measure Information:
Title
28-day all-cause mortality rates
Description
28 days all-cause mortality rates after enrollment
Time Frame
28 days after enrollment
Secondary Outcome Measure Information:
Title
Human leukocyte antigen DR (HLA-DR) expression on cluster of differentiation (CD) 14 T lymphocytes
Description
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
Title
CD 4+/ CD 8+ ratio
Description
CD 4+/ CD 8+ ratio measured on day 0 and 3 after enrollment
Time Frame
day 0 and 3after enrollment
Title
procalcitonin (PCT)
Description
PCT measured on day 0 and 3 after enrollment
Time Frame
day 0 and 3 after enrollment
Title
Sequential Organ Failure Assessment (SOFA) score
Description
SOFA score measured on day 0 and 3 after enrollment
Time Frame
day 0 and 3 after enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fang Lai, Master
Organizational Affiliation
Guangdong Provincial Hospital of Traditional Chinese Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Guangdong Provincial Hospital of Chinese Medicine
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510145
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
31462310
Citation
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.
Results Reference
derived

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

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