Si-ni-tang (a Chinese herbal formula) for improving immunofunction in sepsis: study protocol for a pilot randomized controlled trial

Autor: Shutao Mai, Jiongdong Du, Yanna Weng, Yun Han, Ruifeng Zeng, Dong-ping Xie, Yan Zhang, Yi Zheng, Gengbiao Zhou, Fang Lai, Rong-rong Fan
Jazyk: angličtina
Rok vydání: 2019
Předmět:
Adult
Male
medicine.medical_specialty
China
Surviving Sepsis Campaign
Time Factors
Adolescent
medicine.medical_treatment
Medicine (miscellaneous)
Pilot Projects
Procalcitonin
law.invention
Sepsis
03 medical and health sciences
Study Protocol
Young Adult
0302 clinical medicine
Randomized controlled trial
law
Internal medicine
medicine
Protocol
Humans
Immunologic Factors
Pharmacology (medical)
030212 general & internal medicine
Prospective Studies
immune function
Aged
Randomized Controlled Trials as Topic
Aged
80 and over
lcsh:R5-920
business.industry
Si-ni-tang (SNT)
Immunotherapy
Middle Aged
medicine.disease
Treatment Outcome
Health evaluation
Medical intensive care unit
Adjunctive treatment
Feasibility Studies
Female
Chinese herbal medicine
lcsh:Medicine (General)
business
030217 neurology & neurosurgery
Drugs
Chinese Herbal
Zdroj: Trials
Trials, Vol 20, Iss 1, Pp 1-8 (2019)
ISSN: 1745-6215
0277-7606
Popis: Background Immunologic derangement may be the critical pathophysiologic mechanism in sepsis, and immunotherapy might be a potential new treatment. Si-ni-tang (SNT), an ancient Chinese herbal formula documented in Shanghan Lun, has been used for treating severe sepsis for thousands of years. Research shows that it may have a therapeutic benefit for sepsis. This study will evaluate the feasibility of testing the effects of SNT on immune function in sepsis patients. Methods/design This is a pilot randomized controlled study. Eligible sepsis patients admitted to our medical intensive care unit will be randomly allocated to the control group or the SNT group. Both groups will receive standard therapy according to the recommendations of the Surviving Sepsis Campaign. In addition, the SNT group will receive SNT (150 mL per day for 3 days) orally or by gastric tube, while the control group will receive 150 mL of normal saline. The primary outcome is to assess the feasibility of this treatment. The secondary outcomes include: (1) immune function measured by monocyte human leukocyte antigen-DR (mHLA-DR) expression, procalcitonin, and the ratio of CD4+ to CD8+ T lymphocytes and (2) other clinical data, such as the 28-day all-cause mortality, Sequential Organ Failure Assessment (SOFA) scores, Acute Physiology and Chronic Health Evaluation (APACHE) II scores, both of the latter on days 0 and 3. Discussion This study aims to evaluate the feasibility of testing the efficacy of SNT for treating sepsis when used as an adjunctive treatment with the standard therapy recommended by the Surviving Sepsis Campaign. Trial registration ClinicalTrials.gov, NCT02777606. Registered on 22 June 2016. Retrospectively registered. https://clinicaltrials.gov/ Electronic supplementary material The online version of this article (10.1186/s13063-019-3646-3) contains supplementary material, which is available to authorized users.
Databáze: OpenAIRE
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