The Combination of Phospholipids and Medical Herbs for the Treatment of Patients With Amyotrophic Lateral Sclerosis (ALS); A Pilot Study
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Tolerability and safety based on the number and severity of adverse events (AE)
研究概览
简要总结
The purpose of the study is to evaluate the safety of combining phospholipids with medicinal plants for treatment of patients with amyotrophic lateral sclerosis (ALS)
详细描述
This is an open label pilot study, where patients (n=10) with ALS will take a daily nutritional supplement for 8 months. After documenting the ALS symptom history at baseline, the disease severity, and the motor muscles functions will be assessed at baseline and every two months (0, 2 , 4, 6, 8 months of the treatment). Adverse events and side effect will be assessed on every visit and throughout the experiment. In addition, the level of renal function, liver function and electrolytes will be evaluated from blood samples taken at baseline, 4, and 8 months visits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males aged 18 to 75 years, Females>50 years
- •Diagnosis of "probable" or "definite" ALS according to the El Escorial revised criteria
- •A documented history of ALS symptoms for more than 6 month prior to study enrolment, and no more than 40 month.
- •Patients capable of understanding and signing Informed Consent.
排除标准
- •Patients allergic to seafood
- •Patients with forced vital capacity < 75%
- •Patients who are respiratory dependent, underwent tracheostomy, or cannot swallow.
- •Patients with cardiovascular diseases
- •Patients with diabetes
- •Patients with active peptic ulcers
- •Diagnosis of other neurodegenerative diseases (Parkinson disease, Alzheimer disease, etc).
- •Patients suffering from other chronic significant disease, malignant diseases or any other disease that may risk the patient or interfere with the ability to interpret the results.
- •Patients that can not sign/understand the Informed Consent Form.
- •Female patients who are pregnant or lactating
- •Patients who have received and experimental drug or have participated in a clinical trial within 1 month prior to screening
研究组 & 干预措施
Spirit1
Patients will take a daily nutritional supplement for 8 months
干预措施: Spirit1 (Drug)
结局指标
主要结局
Tolerability and safety based on the number and severity of adverse events (AE)
时间窗: 8 months
Tolerability and safety evaluations will be based on the documentation of the incidence and severity of short term, and long term side effects, and adverse events (AEs) as well as changes in results of blood tests (increase in levels of liver enzymes, decrease in renal function, changes in complete blood count and electrolytes).
次要结局
- Change from baseline in score on the ALS Functional Rating Scale Revised (ALS-FRSr)(4, 8 months)
- Change from baseline in Forced vital capacity (FVC)(2, 4, 6, 8 months)
- Change from baseline in hand grip power using a dynamometer(2, 4, 6, 8 months)
- Change from baseline in walking speed for 10 meters(2, 4, 6, 8 months)