NCT04504305已完成不适用
A Double-blind, Randomized, Placebo-controlled Study to Assess the Efficacy of Investigational Product Nerve Support Formula on the Neuropathic Pain in Individuals Suffering From Type II Diabetes Mellitus.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 4
- 主要终点
- effect of investigational product on diabetic individual suffering from diabetic neuropathy assessed by 11 point numeric rating scale.
研究概览
简要总结
this study is to be carried out to examine the effect of Investigation product on diabetic individuals suffering from diabetic neuropathic pain.
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
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and Females aged ≥ 40 and ≤ 65 years of age.
- •Participants with primary complaints of lower limb pain.
- •History of Diabetes mellitus for more than one year.
- •Participants with HbA1c ≥ 7.1 and ≤ 9.5%
排除标准
- •Diagnosed with severe cardiac disease
- •Uncontrolled hypertension defined as systolic blood pressure ≥ 139 and diastolic blood pressure ≥
- •Type II DM with history of foot ulcers in the last six months prior to the study
- •History of nerve damage not due to Painful Diabetic Neuropathy.
结局指标
主要结局
effect of investigational product on diabetic individual suffering from diabetic neuropathy assessed by 11 point numeric rating scale.
时间窗: 42 days
pain intensity will be assessed by 11 point numeric rating scale where 0 indicates no pain and 10 indicates worst possible pain
次要结局
- effect of investigational product on diabetic individual suffering from diabetic neuropathy assessed by Brief pain inventory.(42 days)
- effect of investigational product on diabetic individual suffering from diabetic neuropathy assessed by Neuropathy total symptom score - 6 .(42 Days)
- effect of investigational product on diabetic individual suffering from diabetic neuropathy assessed by insomnia Severity index.(42 Days)
研究者
研究点 (4)
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