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

NCT ID: NCT02777606

Last Updated: 2023-09-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2019-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Severe Sepsis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Si-Ni-Tang

Intervention Type 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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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Sini decoction

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Guangdong Provincial Hospital of Traditional Chinese Medicine

OTHER

Sponsor Role lead

Responsible Party

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Lai Fang

Attending Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Fang Lai, Master

Role: PRINCIPAL_INVESTIGATOR

Guangdong Provincial Hospital of Traditional Chinese Medicine

Locations

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Guangdong Provincial Hospital of Chinese Medicine

Guangzhou, Guangdong, China

Site Status

Countries

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China

References

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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.

Reference Type DERIVED
PMID: 31462310 (View on PubMed)

Other Identifiers

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2014A020212280

Identifier Type: -

Identifier Source: org_study_id

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