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

Guangdong Provincial Hospital of Traditional Chinese Medicine

Status: Completed

Conditions: Severe Sepsis

Treatments: Drug: Si-Ni-Tang

Study type: Interventional

Funder types: Other

Identifiers

NCT02777606

2014A020212280

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

50 participants in 2 patient groups

Si-Ni-Tang (a Chinese Herbal Formula)

Experimental group

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:

Drug: Si-Ni-Tang

Control

No Intervention group

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.