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

NCT02777606 | Completed

• 1 other identifier: 2014A020212280
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Severe Sepsis

Keywords

Severe Sepsis; Sini Decoction; Immune Function; Mortality

Outcome Measures

Primary Outcomes (1)

• 28-day all-cause mortality rates

  28 days all-cause mortality rates after enrollment

  28 days after enrollment

Secondary Outcomes (4)

• Human leukocyte antigen DR (HLA-DR) expression on cluster of differentiation (CD) 14 T lymphocytes

  day 0 and 3after enrollment

• CD 4+/ CD 8+ ratio

  day 0 and 3after enrollment

• procalcitonin (PCT)

  day 0 and 3 after enrollment

• Sequential Organ Failure Assessment (SOFA) score

  day 0 and 3 after enrollment

Study Arms (2)

Si-Ni-Tang (a Chinese Herbal Formula)

EXPERIMENTAL

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

Control

NO INTERVENTION

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.

Interventions

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.

Also known as: Sini decoction

Si-Ni-Tang (a Chinese Herbal Formula)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Guangdong Provincial Hospital of Traditional Chinese Medicine: lead

Study Sites (1)

Guangdong Provincial Hospital of Chinese Medicine

Guangzhou, Guangdong, 510145, China

Location

Related Publications (1)

• 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.

  PMID: 31462310 DERIVED

MeSH Terms

Conditions

Sepsis

Interventions

sini tang

Condition Hierarchy (Ancestors)

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

Study Officials

• Fang Lai, Master

  Guangdong Provincial Hospital of Traditional Chinese Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Doctor

Study Record Dates

• First Submitted: May 14, 2016
• First Posted: May 19, 2016
• Study Start: June 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: April 1, 2019
• Last Updated: September 13, 2023

Record last verified: 2023-09

Locations

CN (1)