NCT00842881Unknown3 期
Clinical Efficacy and Safety of Healing Stone Navel Belt in Patients With Primary Dysmenorrhea
Healingstone Co., Ltd.0 个研究点目标入组 102 人开始时间: 2008年8月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 102
- 主要终点
- 10cm VAS of pain(Dysmenorrhea)
研究概览
简要总结
The purpose of this study is to determine whether Healing stone navel belt is safe and effective in the treatment of Primary Dysmenorrhea.
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, Care Provider, Investigator)
入排标准
- 年龄范围
- 15 Years 至 45 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age : female adults aged 15~45 years
- •Subjects should diagnosed as primary dysmenorrhea, should have a primary dysmenorrhea at least a 1-day during menstrual.
- •Subjects should have 21~42 days menstrual cycle.
- •menstrual pain : primary dysmenorrhea at least a 1-day during menstruation is over 5 VAS(Visual Analogue Scale) without drug.
- •Subjects must have no Serious internal medicine.
- •Subjects must provide signed informed consent prior to participation in any study-related procedures
排除标准
- •Subject that oral contraceptive taken within 3 months
- •Pregnancy or lactation.
- •Subject have contraceptive that secrete hormone.
- •Secondary dysmenorrhea
- •pelvis inflammatory disease patient
- •Other diseases or characteristics judged by the investigator to be incompatible with the assessments needed in this study or with reliable instillation of the study.
结局指标
主要结局
10cm VAS of pain(Dysmenorrhea)
时间窗: 5months
次要结局
- quality of life (SF-36)(7months)
研究者
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