Safety and Efficacy of the Tong-Fu-Xing-Shen Herbal Formula for Stroke-Associated Pneumonia (TFXSHF)
试验速览
- 阶段
- 4 期
- 入组人数
- 218
- 试验地点
- 1
- 主要终点
- the all-cause mortality rate
研究概览
简要总结
Stroke-associated pneumonia (SAP) is the major complication of acute intracerebral haemorrhage (AICH), leads to poor clinical outcomes and increases the financial burden on the medical system. Prophylactic antibiotics do not reduce the mortality rate of SAP. The Tong-Fu-Xing-Shen herbal formula (TFXS) was shown to be effective for the prevention and treatment SAP in a previous clinical trial. To clarify whether TFXS is effective and safe for the treatment of SAP and affects the immunological mechanism of the "brain-gut-lung" pathway of SAP, the investigators designed this study.
详细描述
This is a multicentre, randomized, double-blind, placebo-controlled clinical trial. A total of 218 patients will be recruited and randomly assigned to the experimental group (EG) or the control group (CG) in a 1:1 ratio. The treatment course will be 10-12 consecutive days, with a 90±7-day follow-up. The primary outcome is the all-cause mortality rate and the mortality of pneumonia at the 90±7-day follow-up. Secondary outcomes include changes in the gut microbiota; changes in the NIHSS score, BI index, mRS score, and Stroke-Specific Quality of Life scale (SS-QOL) score; and so on.
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
- Quadruple (Participant, Care Provider, Investigator, 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Tong-Fu-Xing-Shen herbal formula
Tong-Fu-Xing-Shen herbal formula prescription (0.4g*36 capsules/bottle，1-4 capsules each time, three times a day.) for 10-12days.
干预措施: Tongfu capsules (Drug)
The Placebo of Tong-Fu-Xing-Shen herbal formula
The Placebo of Tong-Fu-Xing-Shen herbal formula prescription (0.4g*36 capsules/bottle，1-4 capsules each time, three times a day.) for 10-12 days.
干预措施: The Placebo of Tongfu capsules (Drug)
结局指标
主要结局
the all-cause mortality rate
时间窗: 90±7 days
Any cause of death
the mortality of stroke associated pneumonia
时间窗: 90±7 days
the death of stroke associated pneumonia
次要结局
- Modified rankin scale (mRS)(after drug 10-12 days, 90±7 days)
- changes in the gut microbiota between the experiment group and the control group(Baseline (before drug), after drug 10-12 days)
- National Institute of Health of stroke scale （NIHSS）(Baseline (before drug), after drug 10-12 days, 90±7 days)
- Stroke Specific Quality Of Life scale (SS-QOL) (SS-QOL) score(90±7 days)
- Barthel index(Baseline (before drug), after drug 10-12 days, 90±7 days)