The Evaluation of Safety and Efficacy of JWHGWT on Diabetic Neuropathy
试验速览
- 阶段
- 3 期
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Short-form (sf)- McGill pain questionnaire (SF-MPQ)
研究概览
简要总结
In order to provide a alternative treatment for relieving the pain and numbness of Diabetes Mellitus patients,Traditional Chinese Medicine powder was tested by subjective questionnaire and objective nerve conduction velocity study. Liver and kidney functions were tested to provided safety profiles.
详细描述
120 participants with diabetic neuropathy were screened in endocrine and metabolism clinics of Taichung Veterans General Hospital and Chinese Medical University Hospital . Subjects were randomly distributed into a double-blind, 12 weeks, placebo-controlled procedure. Subjects were measured by MNSI, SF-BPI, SF-36, SF -MCQ, NCV, AC sugar, HbA1c, lipid profiles, liver and kidney functions.
Safety evaluations including GPT and creatinine revealed no deterioration after treatment. Several domains in MNSI, SF-BPI, SF-36, SF -MPQ questionnaires revealed significant improvements. F-wave in peroneal, tibial nerves and distal latency in tibial nerve in objective nerve conduction studies revealed significant improvements.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of DM
- •Must have the symptoms of pain or numbness
排除标准
- •Patient with pregnancy (or child bearing potential),or in lactation
- •Patient currently taking concomitant TCM medications.
- •Patient with Drug or alcohol addiction
- •Patient with medical history of myocardial infarction, cerebro-vascular disease, major trauma, operation 6 months prior to enrollment
- •Patient with liver dysfunction (SGOT or SGPT>2x ULN)
- •Patient with renal insufficiency (serum creatinine>1.3mg/dL)
研究组 & 干预措施
JWHGWT
干预措施: JWHGWT (Drug)
Placebo
干预措施: placebo (Drug)
结局指标
主要结局
Short-form (sf)- McGill pain questionnaire (SF-MPQ)
时间窗: 0, 4, 8,12 weeks
次要结局
- Nerve conduction study(0,12 weeks)