The Impact of RPh201 on CVS Patients: Clinical and fMRI Measurements
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 主要终点
- change in the awareness status of the patients.
研究概览
简要总结
The investigators are studying the impact of RPh201 on chronic vegetative patients. RPh201 has been reported to induce neuronal regeneration in animal models. Evaluation will be done by combining clinical /behavioral assessment with fMRI studies.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic vegetative patients
排除标准
- •Inability to go through an MRI scans (i.e. metal implants, neurotransmitters)and pregnancy
研究组 & 干预措施
placebo group
Patients will receive 400 microliter s.c., of saline twice a week for 3 months
干预措施: saline (Dietary Supplement)
RPh201 group
Patients will receive 400 microliter s.c., of RPh201 twice a week for 3 months
干预措施: RPh201 (Dietary Supplement)
结局指标
主要结局
change in the awareness status of the patients.
时间窗: 3-6 months
Clinical and laboratory assessment will be done every two weeks along the treatment period fMRI assessment will be performed 3 times: before the treatment, immediate afterwards and one month following treatment cessation.
次要结局
- change in the awareness status of the patients.(1 month following the end of the trial)