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Completed

NCT Number: NCT02777606

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

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.

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Key information

Conditions

Severe Sepsis Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Systemic Inflammatory Response Syndrome

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Guangdong Provincial Hospital of Chinese Medicine

Guangzhou, Guangdong, 510145, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Si-Ni-Tang

Drug

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

Primary outcomes

  1. 28-day all-cause mortality rates

    Time frame: 28 days after enrollment

    28 days all-cause mortality rates after enrollment

Secondary outcomes

  1. 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

  2. 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

  3. procalcitonin (PCT)

    Time frame: day 0 and 3 after enrollment

    PCT measured on day 0 and 3 after enrollment

  4. Sequential Organ Failure Assessment (SOFA) score

    Time frame: day 0 and 3 after enrollment

    SOFA score measured on day 0 and 3 after enrollment

Sponsors and collaborators

Lead sponsor

Guangdong Provincial Hospital of Traditional Chinese Medicine

Other

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
May 19, 2016
Registry last updated
Sep 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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