China Amyotrophic Lateral Sclerosis Registry of Patients With Traditional Chinese Medicine
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- Effective Survival
研究概览
简要总结
A multi-center registration study of clinical characteristics of amyotrophic lateral sclerosis (ALS) patients with traditional Chinese medicine (TCM).
详细描述
The CARE-TCM is a prospective, multi-center, patient registry study. Eligible ALS patients with TCM treatments will be enrolled in the registry. After enrollment, this research collects the individual characteristics of patients' status. Longitudinal follow-up data are collected from both patients (primary caregivers) and their treating neurologists every 3 months for 5 years. The aims of the CARE-TCM are to: 1) explore the general characteristics of ALS patients with TCM and; 2) assess the effectiveness and safety of various TCMs on ALS based on nationwide registry outcome collecting process.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18 years and older.
- •Patients with possible, laboratory supported probable, probable, or definite ALS according to the revised El Escorial criteria.
- •ALS patients treated with traditional Chinese medicine.
排除标准
- •Patients who refuse informed consent.
结局指标
主要结局
Effective Survival
时间窗: Through study completion, an average of 3 months
The time from disease onset to death, tracheostomy, or permanent assisted ventilation
次要结局
- Rate of Disease Progression(Through study completion, an average of 3 months)
- Rate of Forced Vital Capacity (FVC) Decline(through study completion, an average of 3 months)
- Overall Survival(Through study completion, an average of 3 months)
- Rate of Body Mass Index (BMI) Decline(Through study completion, an average of 3 months)
研究者
Ying Gao
MD, PhD, Professor
Dongzhimen Hospital, Beijing