An Open-label, Randomized, Multi-center Clinical Trial to Evaluate the Safety and Efficacy in Peripheral Neuropathies Patients Treated With Mecobalamin Injection
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 1,072
- 试验地点
- 23
- 主要终点
- Value of the Peripheral Neuropathy Total Symptom Score (TSS) Compared to Baseline
研究概览
简要总结
This is an open-label, randomized, multi-center clinical trial to evaluate the safety and efficacy in peripheral neuropathies patients treated with Mecobalamin Injection
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
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Group A: Diabetic Peripheral Neuropathy (IV)
干预措施: Mecobalamin IV Injection (Drug)
Group B: Diabetic Peripheral Neuropathy (IM)
干预措施: Mecobalamin IM injection (Drug)
Group C: Idiopathic Peripheral Neuropathy
干预措施: Mecobalamin IV or IM injection (Drug)
Group D: Nutritional & Metabolic Peripheral Neuropathy
干预措施: Mecobalamin IV or IM injection (Drug)
Group E: Compression Peripheral Neuropathy
干预措施: Mecobalamin IV or IM injection (Drug)
结局指标
主要结局
Value of the Peripheral Neuropathy Total Symptom Score (TSS) Compared to Baseline
时间窗: Baseline & End of Week 4
The TSS of peripheral neuropathy is used to score the intensity \& frequency of four symptoms in participants' feet/legs including: pain, burning sensation, numbness, and hypoesthesia. Frequency is ranked as asymptomatic, occasionally (2-3 times/ week), often (1-2 times/ day), \& continuous (nearly all day). Intensity is evaluated by visual analogue scale (VAS) score: 0 (zero intensity)- 10 (max. intensity). Participants described intensity by marking the number corresponding to severity of symptom they felt in a 10 cm long straight line and investigators distinguished whether it was mild (score: 1-3), moderate (score: 4-6), or severe (score: 7-10). The total score of four symptoms was considered the TSS. Total scores ranged from 0-14.64 points, where 0 was lowest symptom score and 14.64 was most severe level of symptoms. Baseline (before treatment) scores were compared to scores after 4 weeks of treatment.
Rate of the Peripheral Neuropathy Total Symptom Score (TSS) Compared to Baseline
时间窗: Baseline and End of Week 4
TSS of peripheral neuropathy is used to score the intensity \& frequency of 4 symptoms in participants' feet/legs including: pain, burning sensation, numbness, hypoesthesia. Frequency is ranked as asymptomatic, occasionally (2-3 times/ week), often (1-2 times/ day), \& continuous (nearly all day). Intensity is evaluated by visual analogue scale (VAS) score: 0 (zero intensity)- 10 (max. intensity). Participants described intensity by marking the number corresponding to severity of symptom they felt in a 10 cm long straight line and investigators distinguished whether it was mild (score: 1-3), moderate (score: 4-6), or severe (score: 7-10). The total score of four symptoms was considered the TSS. Total scores ranged from 0-14.64 points, where 0 was lowest symptom score and 14.64 was most severe level of symptoms. Baseline scores were compared to TSS decreasing rate after 4 weeks of treatment. Rate of TSS change = (TSS difference value/TSS before treatment)×100%.
次要结局
- Value of the Peripheral Neuropathy Total Symptom Score (TSS) Compared to Baseline(Baseline and End of Week 2)
- Rate of the Peripheral Neuropathy Total Symptom Score (TSS) Compared to Baseline(Baseline and End of Week 2)
- Value of the Neural Injury Score of the Lower Limbs (NIS-LL) Compared to Baseline(Baseline and End of Week 4)
- Rate of the Neural Injury Score of the Lower Limbs (NIS-LL) Compared to Baseline(Baseline and End of Week 4)