Research on Effectiveness of Nanoone Woman Underwear Using in the Management of Dysmenorrhea
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- The Mean Change in Maximum Pain Level at Each Menstrual Cycle From Baseline
研究概览
简要总结
To evaluate the mean change in menstrual pain intensity during menstrual cycles from baseline after wearing Nanoone Woman Underwear in women with primary dysmenorrhea
详细描述
The severity of dysmenorrhea pain experienced by subjects will be evaluated on a VAS, ranging from zero (no pain) to ten (very severe pain). Subjects will be asked to use the VAS scoring system to record, on a provided sheet, their experienced menstrual pain level daily during menstrual bleeding for a total of three consecutive menstrual cycles.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 40 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Females aged below 40 years old.
- •Screened by inquiry and diagnosed as primary dysmenorrhea by gynaecologist with pelvic ultrasonography.
- •Female subject who is:
- •using adequate contraception since last menstruation and no plan for conception during the study.
- •non-lactating.
- •has negative pregnancy test (urine) within 14 days prior to the study.
- •Informed consent form signed.
排除标准
- •Sensitivity to study product.
- •Patient has been diagnosed with secondary dysmenorrhea (defined as identifiable pelvic pathology).
- •Patient has clinically significant physical disability or abnormal findings on physical examination or laboratory testing judged by the investigator or co-investigator.
- •Participation of any clinical investigation during the last 30 days.
结局指标
主要结局
The Mean Change in Maximum Pain Level at Each Menstrual Cycle From Baseline
时间窗: baseline, first menstrual cycle, second menstrual cycle and third menstrual cycle
The severity of dysmenorrhea pain experienced by subjects will be evaluated on a VAS, ranging from zero (no pain) to ten (very severe pain).
次要结局
未报告次要终点