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

September 11, 2023 updated by: Lai Fang, Guangdong Provincial Hospital of Traditional Chinese Medicine
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510145
        • Guangdong Provincial Hospital of Chinese Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Si-Ni-Tang (a Chinese Herbal Formula)
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
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.
Other Names:
  • Sini decoction
No Intervention: Control
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?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangdong Provincial Hospital of Traditional Chinese Medicine

Investigators

  • Principal Investigator: Fang Lai, Master, Guangdong Provincial Hospital of Traditional Chinese Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2016

Primary Completion (Actual)

December 1, 2018

Study Completion (Actual)

April 1, 2019

Study Registration Dates

First Submitted

May 14, 2016

First Submitted That Met QC Criteria

May 18, 2016

First Posted (Estimated)

May 19, 2016

Study Record Updates

Last Update Posted (Actual)

September 13, 2023

Last Update Submitted That Met QC Criteria

September 11, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014A020212280

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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