Evaluation of Topical Citrullus Colocynthis Fruit Oil Efficacy in Treatment of Painful Peripheral Diabetic Neuropathy
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Pain Scores on the Neuropathic Pain Scale (NPS)
研究概览
简要总结
This study is designed to evaluate the topical Citrullus colocynthis fruit oil efficacy in treatment of painful peripheral diabetic neuropathy (PDN) in a randomized double blind placebo-controlled clinical trial design. This study includes 60 patients from SUMS endocrinology and diabetes clinic. Patients with painful conditions other than PDN such as radiculopathies will be excluded. After giving the Informed consent the patients will be underwent NCS (Nerve Conduction Study) for confirming the diagnosis before recruitment. They will be followed for 12 weeks and after 12 weeks the outcome measures including Neuropathic Pain Scale (NPS), WHOQOL-BREF (World Health Organisation Quality of Life Brief) questionnaire and electrodiagnostic criteria will be evaluated.
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 70 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
Topical Citrullus colocynthis fruit oil
Topical Citrullus colocynthis fruit oil (1%) 1 cc twice daily
干预措施: Topical Citrullus colocynthis fruit oil (1%) (Drug)
Placebo (Vehicle)
Topical vehicle oil 1 cc twice daily
干预措施: Topical vehicle oil (Drug)
结局指标
主要结局
Pain Scores on the Neuropathic Pain Scale (NPS)
时间窗: 12 weeks
次要结局
- Motor amplitude (microvolt) of tibial nerve(12 weeks)
- Sensory amplitude (microvolt) of sural nerve(12 weeks)
- Sensory amplitude (microvolt) of SPN(12 weeks)
- Nerve Conduction Velocity (NCV) (m/sec) of common peroneal nerve (CPN)(12 weeks)
- Distal latency (millisecond) of sural nerve(12 weeks)
- WHOQOL-BREF Score(12 weeks)
- Number of Participants with Adverse Events(12 weeks)
- NCV (m/sec) of tibial nerve(12 weeks)
- Distal latency (millisecond) of superficial peroneal nerve (SPN)(12 weeks)
- Motor amplitude (microvolt) of CPN(12 weeks)
研究者
Mesbah Shams, MD
Dr. Mesbah Shams
Shiraz University of Medical Sciences