Clinical Trials Logo
  1. Home
  2. Severe Sepsis
  3. NCT02777606
  4. Details
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
See also
  Status Clinical Trial Phase
Completed NCT04804306 - Sepsis Post Market Clinical Utility Simple Endpoint Study - HUMC
Completed NCT04227652 - Control of Fever in Septic Patients N/A
Recruiting NCT04005001 - Machine Learning Sepsis Alert Notification Using Clinical Data Phase 2
Recruiting NCT02899143 - Short-course Antimicrobial Therapy in Sepsis Phase 2
Completed NCT02539147 - Characterization of Non-canonical Way in Inflammasome Monocytes of Patients With Severe Sepsis N/A
Completed NCT01932814 - Acute Kidney Injury in Septic Critically Ill Patients : Are Aminoglycosides Really Harmful? N/A
Completed NCT01929772 - German Lactat Clearance in Severe Sepsis N/A
Completed NCT01449721 - Preemptive Resuscitation for Eradication of Septic Shock N/A
Active, not recruiting NCT01162109 - Zinc Therapy in Critical Illness Phase 1
Not yet recruiting NCT01211899 - 4G/5G Polymorphism of Plasminogen Activator Inhibitor-1 Gene and Disseminated Intravascular Coagulation in Severe Sepsis and Septic Shock N/A
Completed NCT00934011 - Use of Inflammatory Biomarkers to Guide Antibiotic Therapy in Patients With Severe Infections N/A
Recruiting NCT00335907 - Protocol-driven Hemodynamic Support for Patients With Septic Shock N/A
Completed NCT00463645 - Investigation of Correlation Between Interstitial and Arterial Blood Glucose Concentrations in Septic Patients N/A
Completed NCT02361528 - GM-CSF to Decrease ICU Acquired Infections Phase 3
Completed NCT02734550 - (1,3)-β-D-glucan Based Diagnosis of Invasive Candida Infection in Sepsis N/A
Completed NCT02973243 - The Vital Signs to Identify, Target, and Assess Level (VITAL) Care Study III N/A
Terminated NCT03895853 - Early Metabolic Resuscitation for Septic Shock Phase 2
Completed NCT01945983 - Early Use of Norepinephrine in Septic Shock Resuscitation N/A
Completed NCT01598831 - Phase 3 Safety and Efficacy Study of ART-123 in Subjects With Severe Sepsis and Coagulopathy Phase 3
Enrolling by invitation NCT02258984 - Can the Venus 1000 Help Clinicians Treat Patients With Severe Sepsis or Acute Heart Failure? The CVP Trial N/A