A Triple-Blind Randomised Clinical Trial on the Effectiveness of CBD for Neuropathic Pain in Diabetic Foot Neuropathy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Assessment of neuropathic pain.
研究概览
简要总结
Evaluation of cannabidiol and urea 10%.
详细描述
This study evaluated the impact of cannabidiol on neuropathic pain and the action of urea 10% on skin quality in patients with diabetic foot syndrome and diabetic neuropathy.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients all biological sexes
- •Patients of legal age (18 years).
- •Patients without cognitive impairment
- •Patients Diagnosed with diabetic neuropathy,
- •Patients who were able to complete the neuropathic pain scale autonomously, cooperatively and independently.
排除标准
- •Patients who declined participation
- •Patients with critical ischaemia and
- •Patients with a history of allergy or hypersensitivity to any of the components of the cream were excluded from the study.
研究组 & 干预措施
Group 1. Complete formula.
Participants in this group received a cream with cannabidiol, urea 10%, arnica and menthol as active ingredients during 1 month.
干预措施: Group 1. Complete formula (Drug)
Group 2. Cannabidiol and Urea 10% formula.
Participants in this group received a cream with cannabidiol, urea 10% as active ingredients during 1 month.
干预措施: Group 2. Cannabidiol and Urea 10% formula. (Drug)
Group 3. Base formula.
Participants in this group received a base cream with no active ingredients.
干预措施: Group 3. Placebo formula. (Drug)
结局指标
主要结局
Assessment of neuropathic pain.
时间窗: From randomisation and delivery of the assigned formula until the end of the intervention after one month of application.
Neuropathic pain was assessed using the validated neuropathic pain assessment scale.
次要结局
- Skin quality assessment(From randomisation and delivery of the assigned formula until the end of the intervention after one month of application.)
研究者
María del Sol Tejeda Ramírez
Podiatrist. Specialist in diabetic foot.
Universidad Complutense de Madrid