The Efficacy of Si-Ni-Tang (a Chinese Herbal Formula) for Severe Sepsis
NCT ID: NCT02777606
Last Updated: 2023-09-13
Study Results
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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COMPLETED
NA
50 participants
INTERVENTIONAL
2016-06-30
2019-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
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.
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.
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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion 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
* 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
18 Years
85 Years
ALL
No
Sponsors
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Guangdong Provincial Hospital of Traditional Chinese Medicine
OTHER
Responsible Party
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Lai Fang
Attending Doctor
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
Countries
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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.
Other Identifiers
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2014A020212280
Identifier Type: -
Identifier Source: org_study_id
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