NCT07257770招募中不适用
Evaluating the Effect of a Medical Device Based on Inositol in Improving Breast Pain
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Reduction of breast pain
研究概览
简要总结
The trial aims to investigate the effect of a topical application of a medical device based on inositol in recovering breast pain
详细描述
The present study enrolled patients with breast pain (measured through the VAS) aiming to evaluate the improvement of the pain after the local treatment
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
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged between 18 and 70 years
- •Women who underwent breast surgery at least 15 days prior
- •Women experiencing breast pain associated with the surgical wound
排除标准
- •Women under the age of 18
- •Ongoing systemic and/or local pain therapy
- •Pregnant women
研究组 & 干预措施
Control
No Intervention
No treatment, clinical follow up
treatment inositol
Experimental
daily administration of the gel
干预措施: inositol (Device)
结局指标
主要结局
Reduction of breast pain
时间窗: 3 months
Breast pain is evaluated by using VAS (Visual Analogue Scale)
次要结局
- Follow up breast pain(6 months)
研究者
研究点 (1)
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