Effect of Minocicline Use in Less Neurologic Sequels in Patients With Stroke
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 134
- 试验地点
- 1
- 主要终点
- To determine the efficacy of minocycline in reducing neurological sequelae in patients with stroke
研究概览
简要总结
The investigators will evaluate the National Institute of Health Stroke Scale/Score (NIHSS)in patients with stroke, and then give Minocycline 100mg po every 12 hours or placebo for five days, then perform periodic evaluations to determine the status and degree of neurological sequelae developed.
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
- Triple (Participant, Care Provider, Investigator)
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
- •NIHSS scale greater than 5
- •Onset of symptoms less than 24 hours
- •normal Cranial Tomography(CT)
- •CT evidence of cerebral ischemia
- •Acceptance of study entry
排除标准
- •Hemorrhagic cerebrovascular disease
- •Other neurological diseases
- •Concomitant structural damage
- •History of neurosurgery
- •Known allergy to tetracyclines
- •Concomitant infectious diseases requiring antibiotic treatment.
- •History of Stroke
- •Women pregnant or breast-feeding
研究组 & 干预措施
Minocicline
minocicline 100mg oral twice a day for 5 days
干预措施: Minocicline (Drug)
Placebo
Pills filled with vegetal fiber with similar presentation of the drug. Given one pill oral twice a day for five days
干预措施: Placebo (Drug)
结局指标
主要结局
To determine the efficacy of minocycline in reducing neurological sequelae in patients with stroke
时间窗: one year
The researchers evaluated the neurological condition of paralysis, aphasia,and level of consciousness by NIHSS score for each patient with stroke and proceeded to give minocycline or placebo. Then, the assessment was repeated after five and thirty days post treatment to determine whether their neurological sequelae had diminushed.
次要结局
- Identify the side effects of the intervention administered during the treatment time and 30 days later.(one year)
研究者
Nataly Bedoya
Internist
Hospital Universitario Hernando Moncaleano Perdomo