The Effect of Huatuo Zaizao Pill on Neurological Function and Motor Recovery in Ischemic Stroke Patients During the Recovery Stage: a Open-labelled, Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Modified Ashworth Scale (MAS)
研究概览
简要总结
The purpose of this study was to evaluate the improvement of limb motor function and nerve function of patients with HTZZ during stroke rehabilitation. A total of 80 subjects will be randomly assigned to Huatuo Zaizao pill group or the control group.
详细描述
This is a prospective, randomized controlled clinical trial. Eighty patients with phlegm and blood stasis block syndrome of ischemic stroke were randomly assigned to Hua Hua reconstruction group or control group at a ratio of 1:1. The treatment period is 12 weeks. The purpose is to evaluate its efficacy and safety, provide an objective basis for precise treatment of traditional Chinese medicine, and improve clinical efficacy. The main result is the changes of MAS scores 12 weeks days after taking the drug. The secondary result is the change in NIHSS, Fugl-Meyer and BI.
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)
盲法说明
Participants are randomly and evenly assigned to 2 groups using block randomization.Random numbers are generated by the stratified random method using the Statistical Analysis Software （SAS） statistical software and assigned by an independent statistician at the Good Clinical Practice Institute of XiYuan Hospital.
入排标准
- 年龄范围
- 35 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1.Aged between 35 and 75 years old
- •2.With a disease course between 2 weeks- 24weeks
- •3.Meeting the diagnostic criteria of ischemic stroke
- •4.Signed and dated written informed consent.
- •5.4≤NIHSS score≤22
排除标准
- •1.Unstable vital signs, or serious heart, liver, lung, kidney and other organ diseases
- •2.Exclude Transient Ischemic Attack(TIA)
- •3.Patients who are participating in clinical trials of other drugs within the past 1 month
- •4.Pregnant or breastfeeding women
- •5.Athletes, Epileptics, Allergic to this product
研究组 & 干预措施
HuaTuo ZaiZao group
In this arm, patients take 8g of HuatuoZaizao pill three times a day. Besides，participants will receive basic treatment in accordance with the "Guidelines for diagnosis and treatment of ischemic stroke in China",and the drug and dosage will be formulated by the researchers according to the clinical situation.Treatment lasts for 12 weeks
干预措施: Huatuo Zaizao Pills (Drug)
HuaTuo ZaiZao group
In this arm, patients take 8g of HuatuoZaizao pill three times a day. Besides，participants will receive basic treatment in accordance with the "Guidelines for diagnosis and treatment of ischemic stroke in China",and the drug and dosage will be formulated by the researchers according to the clinical situation.Treatment lasts for 12 weeks
干预措施: Basic treatment (Other)
Control group
participants will receive basic treatment in accordance with the "Guidelines for diagnosis and treatment of ischemic stroke in China",and the drug and dosage will be formulated by the researchers according to the clinical situation.Treatment lasts for 12 weeks
干预措施: Basic treatment (Other)
结局指标
主要结局
Modified Ashworth Scale (MAS)
时间窗: The change from baseline in Modified Ashworth Scale (MAS) score at week 6 and 12 [Time Frame: Baseline,6th week±3 days, 12th week±3 days]
Modified Ashworth Scale (MAS) measure spasticity. During the administration of MAS , the examiner passively moves the joint being tested and rates the perceived level of resistance in the muscle groups opposing the movement.It is single-item measures ranging from 0 to 4, where 0 indicates no increase in muscle tone and 4 indicates that the affected part is rigid in flexion or extension.
次要结局
- National Institute of Health Stroke Scale (NIHSS )(The change from baseline in National institute of health stroke scale (NIHSS ) score at week 6 and 12 [Time Frame: Baseline,6th week±3 days, 12th week±3 days])
- Fugl-Meyer(The change from baseline in Fugl-Meye score at week 6 and 12 [Time Frame: Baseline,6th week±3 days, 12th week±3 days])
- Barthel Index（BI）(The change from baseline in BI total score at week 6 and 12 [Time Frame: Baseline,6th week±3 days, 12th week±3 days])