NCT02777606已完成不适用
The Efficacy of Si-Ni-Tang (a Chinese Herbal Formula) for Severe Sepsis
Guangdong Provincial Hospital of Traditional Chinese Medicine1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2016年6月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- 28-day all-cause mortality rates
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
Si-Ni-Tang (a Chinese Herbal Formula)
Experimental
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.
干预措施: Si-Ni-Tang (Drug)
结局指标
主要结局
28-day all-cause mortality rates
时间窗: 28 days after enrollment
28 days all-cause mortality rates after enrollment
次要结局
- procalcitonin (PCT)(day 0 and 3 after enrollment)
- Human leukocyte antigen DR (HLA-DR) expression on cluster of differentiation (CD) 14 T lymphocytes(day 0 and 3after enrollment)
- CD 4+/ CD 8+ ratio(day 0 and 3after enrollment)
- Sequential Organ Failure Assessment (SOFA) score(day 0 and 3 after enrollment)
研究者
Lai Fang
Attending Doctor
Guangdong Provincial Hospital of Traditional Chinese Medicine
研究点 (1)
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