The Clinical Study of Botulinum Toxin Type A Injection in the Treatment of Wilson Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Unified Dystonia Rating Scale(UDRS)
研究概览
简要总结
In order to expand the treatment of Wilson disease and improve the quality of life of patients with Wilson's disease, the clinical effect of botulinum toxin type A injection on Wilson's disease was discussed.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 15 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Non-Wilson's disease
研究组 & 干预措施
botulinum toxin type A
Enrolled patients were given basic copper discharge treatment, including sodium dimercaptopropyl sulfonate injection, dimercaptosuccinic acid capsules, zinc gluconate tablets, benzoxol hydrochloride tablets, etc. Local injection of botulinum toxin type A was given at the time of enrollment.
Placebo Comparator: Control group Arm Description: Enrolled patients were treated with DMPS basic copper expulsion therapy, including sodium dithioglycolate injection, dithioglycolic acid capsules, zinc gluconate tablets, benzoxol hydrochloride tablets, etc.
干预措施: Botulinum toxin type A (Drug)
结局指标
主要结局
Unified Dystonia Rating Scale(UDRS)
时间窗: 4 weeks
Unified Dystonia Rating Scale(UDRS),Higher scores mean a worse outcome.
Unified Wilson's Disease Rating Scale(UWDRS)
时间窗: 4 weeks
Unified Wilson's Disease Rating Scale(UWDRS).Higher scores mean a worse outcome
Numeric Rating Scales(NRS)
时间窗: 4 weeks
Numeric Rating Scales(NRS),Higher scores mean a worse outcome
Activity of Daily Living Scale(ADL)
时间窗: 4 weeks
Activity of Daily Living Scale,Higher scores mean a better outcome.
次要结局
未报告次要终点
研究者
Jun Li
Chief physician
The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine