Efficacy and Safety of Chinese Medicine Angong Niuhuang Wan for the Treatment of the Stroke: A Randomized, Double-blind,Placebo Controlled Clinical Trial
试验速览
- 阶段
- 2 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Score of neurological deficit and adverse events
研究概览
简要总结
To evaluate the efficacy and safety of using Chinese Medicine Angong Niuhuang Wan in stroke patients, the modified Rankin Scale (mRS) score will be used as primary outcome, the National Institutes of Health Stroke Scale (NIHSS) score, The Modified Barthel Index (MBI) score and the Montreal Cognitive Assessment (MoCA) scores will be used as secondary outcome measures.
详细描述
This study is a randomized, double-blind, placebo-controlled trial which is used to further determine the effectiveness of Angong Niuhuang Wan in treating stroke patients on top of the standard conventional treatment, also to evaluate the improvement level on quality of life of post-stroke after using Angong Niuhuang Wan. The effect of Angong Niuhuang Wan on liver and kidney function will be focused and using NMR techniques to analysis metabolomics to further study the safety and effectiveness of Angong Niuhuang Wan on the prevention and treatment of stroke.
It is a 24-week trial, Double-blind treatment for 1 week, follow up visit for 23 weeks. All participant will have study blood taking for renal and liver function test and questionnaires assessment during study visits. Informed consent will be obtained before study enrollment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chinese adults aged 40 or above;
- •diagnosed as a stroke by a neurologist, with imaging of CT or MRI support;
- •Neurologist confirms the symptoms of stroke occur within 28 days and are clinically stable. In the past 48 hours, the condition of the nervous system has not deteriorated significantly;
- •TCM diagnosis is a stroke and belongs to a heat syndrome;
- •There is a movement defect caused by stroke;
- •The severity of stroke was scored 5-25 by the National Institutes of Health Brain Stroke Scale (NIHSS);
- •Informed consent will be given by participant or its representatives
排除标准
- •The movement defects are not associated with stroke. Before commencement of study treatment, patient has physical activity dysfunction caused by lameness , osteoarthritis, rheumatoid arthritis, gouty arthritis, etc. that may affect neurological function examination;
- •Subjects are unlikely to come back for follow-up visits during the 24-week study period;
- •The subject has a brain tumor on a computed tomography scan (CT);
- •The subject has thrombocytopenia (known platelet count <100,000 / mm3) or coagulopathy disease;
- •Taking warfarin or other anticoagulant;
- •Concomitant diseases such as severe hypertension or diabetes;
- •Comorbidities or complications associated with drug evaluation;
- •Pregnant or breast-feeding female.
- •The alanine aminotransferase (ALT) value is 1.5 times higher than the normal maximum value in liver function test and the estimated glomerular filtration rate (eGFR) <30 ml/min/1.73 m2 in the renal function test.
- •Present the sign of pure yin syndrome or yin / yang defecation in TCM diagnosis;
- •Subject has G6PD
- •Known swallowing problem
- •Dependent in all daily life activities
研究组 & 干预措施
Treatment Group
Chinese Medicine of Angong Niuhuang Wan
干预措施: Angong Niuhuang Wan (Drug)
Placebo Group
Placebo of Angong Niuhuang Wan
干预措施: Angong Niuhuang Wan Placebo (Drug)
结局指标
主要结局
Score of neurological deficit and adverse events
时间窗: 24 weeks
compare the therapeutic effects, the score of neurological deficit and adverse events between the two groups by using questionnaire of mRS, higher scores mean a worse outcome
次要结局
- Mortality and recurrence rates of stroke(24 weeks)
研究者
Alexander Lau
Assistant Professor
Chinese University of Hong Kong