The efficacy of combined oral formulation of acetyl-L carnitine, palmitoyl ethanolamide and vitamin B12 in alleviating pain in diabetic neuropathy- A randomised control trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Reduction in neuropathic pain measured by Visual Analogue Score(VAS) and improvement in nerve conduction velocity
研究概览
简要总结
This study is a randomized, double blinded, parallel group, single center trial comparing the efficacy of combined oral formulation of Acetyl-L carnitine(500mg),Palmitoyl Ethanolamide(300mg ) and Vitamin-B12(1500mcg) for 3 months with placebo for 3months in patients with diabetic peripheral neuropathy. A total of 68 patients are to be included in the trial. The primary outcome is reduction in neuropathic pain by assessing Visual Analogue Score(VAS) and improvement in nerve conduction velocity. The secondary outcomes are improvement in quality of life and assessing the rate of clinical adverse reactions at 3 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patient diagnosed with Type-2 diabetes mellitus for more than a year 2.HbA1c of more than 5.9% 3.Patients experiencing moderate to severe neuropathic pain assessed by Visual Analogue Score(VAS) for pain 4.Abnormal nerve conduction velocity and amplitude in at least one of the nerve extremities.
排除标准
- •1.Patients with neuropathy due to other causes other than diabetes mellitus 2.History of alcohol or use of any other illicit drugs 3.Pregnant and lactating women 4.Participation in another clinical trial that might interfere with this study’s result.
结局指标
主要结局
Reduction in neuropathic pain measured by Visual Analogue Score(VAS) and improvement in nerve conduction velocity
时间窗: 3 months
次要结局
- Improvement in quality of life and assessing the rate of clinical adverse reactions(3 months)
研究者
Dr Yohidha Balamurugan
Saveetha Medical College and Hospital