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

Ruifeng Zeng, Yi Zheng, Rongrong Fan, Gengbiao Zhou, Yan Zhang, Shutao Mai, Dongping Xie, Yanna Weng, Jiongdong Du, Yun Han, Fang Lai, Ruifeng Zeng, Yi Zheng, Rongrong Fan, Gengbiao Zhou, Yan Zhang, Shutao Mai, Dongping Xie, Yanna Weng, Jiongdong Du, Yun Han, Fang Lai

Abstract

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/.

Keywords: Chinese herbal medicine; Protocol; Sepsis; Si-ni-tang (SNT); immune function.

Conflict of interest statement

The authors declare that they have no competing interests. None of the authors have received funding or research grants from the manufacturers of the drug used in this research.

Figures

Fig. 1
Fig. 1
Study flow chart. mHLA-DR monocyte human leukocyte antigen-DR, SOFA Sequential Organ Failure Assessment, APACHE Acute Physiology and Chronic Health Evaluation, PCT procalcitonin, SSC Surviving Sepsis Campaign
Fig. 2
Fig. 2
Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) timeline of measurements. Laboratory examination includes the immune function data (mHLA-DR expression, ratio of CD4+ to CD8+ T lymphocytes), inflammation data (C-reactive protein, interleukin-6, interleukin-10, PCT and TNF-α), complete blood count (CBC), general urine analysis, liver function tests (ALT, AST, ALP, TBIL, and GGT), renal function test (BUN and Scr). ALT alanine transaminase, ALP alkaline phosphatase, AST aspartate transaminase, BUN blood urea nitrogen, CBC complete blood count, GGT gamma-glutamyltransferase, mHLA-DR monocyte human leukocyte antigen-DR, PCT procalcitonin, TBIL total bilirubin, TNF-α Tumor necrosis factor α, Scr serum creatinine,SNT Si-Ni-Tang,SPIRIT Standard Protocol Items: Recommendations for Interventional Trials

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