A Randomized, Crossover, Double Blinded, Placebo Controlled Trial of Topical Capsaicin in Treatment of Painful Diabetic Neuropathy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Pain relief from pain score reduction, using visual analog scale (VAS)
研究概览
简要总结
Painful diabetic neuropathy is the most common cause of neuropathic pain. 0.075% topical capsaicin has been used to treat the pain, but there is no data in lower concentration. This is the efficacy and safety of 0.025% topical capsaicin in treatment of painful diabetic polyneuropathy.
详细描述
Patient is randomized to receive either 0.025% topical capsaicin or vehicle control (placebo) for 8 weeks. After one week wash-out period, patients will be switched to the other group for 8 weeks.
Outcome will be assessed by visual analog scale, neuropathic pain scale, SF-MPQ, SF-36. Safety and tolerability will be recorded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of type 2 Diabetes mellitus
- •Peripheral neuropathy
- •Stabilized on pain medication for at least one month
- •No previous invasive intervention for pain relief
排除标准
- •Local wound or skin abnormality in the applicable area
- •Allergic to capsaicin
- •Refuse to participate or give consent
- •Has other significant disease or receive medication that may worsen neuropathy
研究组 & 干预措施
Capsaicin
干预措施: Capsaicin (Drug)
placebo
干预措施: placebo (Drug)
结局指标
主要结局
Pain relief from pain score reduction, using visual analog scale (VAS)
时间窗: 8 weeks
次要结局
- Overall clinical improvement, measured by Clinician Global Impression of Change(CGIC)(8 weeks)
研究者
Kongkiat Kulkantrakorn
Associate Professor
Thammasat University