Randomized Controlled Trial of Acupuncture on the Effect of Quality of Life and Clinical Efficacy for Dysmenorrhea Patients.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- visual analogue scale of pain
研究概览
简要总结
Since there is unsatisfactory effect by currently pharmacologic therapies and preventive strategies for dysmenorrhea, this study is designed to evaluate the efficacy and quality of life of acupuncture for patients with dysmenorrhea based on the theory of traditional Chinese Medicine.
详细描述
There were abundant clinical experiences and medical records for dysmenorrhea in traditional Chinese medicine. So we follow the worldly trend to do the research of integrative Chinese medicine and western medicine since WHO launched the first global strategy on traditional and complementary/alternative medicine (TM/CAM) to assist countries to create a stronger evidence base on the safety, efficacy and quality of the TM/CAM products and practices.
The purpose of our study is to create the evidence of effect on dysmenorrhea by acupuncture. The study will be performed under randomized, open, controlled design. The effect of acupuncture and control group will be compared including the following outcomes: pain score (Visual Analogue Scale), quality of life (SF-36, Taiwan version), overall improvement in dysmenorrhea, adverse effects from treatment, requirements for additional medication, restriction of daily life activities, absence from work or school.
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
- 13 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •non-pregnant women who are at least 13 years old
- •the one who meet any one of the following two criteria: 1.suffering from dysmenorrhea in recent 3 menstrual periods; 2.dysmenorrhea with poor response to non-steroid anti-inflammation drugs
排除标准
- •intrauterine device-related dysmenorrhea
- •history of alcohol or drug abuser
- •women who are pregnant, as determined by a urine pregnancy test
- •history of adverse reaction to acupuncture
- •received herb or acupuncture therapy within one month prior to enrollment
- •poor compliance to investigator's advice
结局指标
主要结局
visual analogue scale of pain
时间窗: every 2 months
次要结局
- score of questionnaire of quality of life (SF-36)(every 2 months)
- amount of additional medication(every 2 months)
- degree of restriction of daily life activities(every 2 months)
- degree of absence from work or school(every 2 months)
- overall improvement in dysmenorrhea(end of acupuncture treatment)
- safety evaluation (adverse events)(every week)
- score of questionnaire of dysmenorrhea-related symptoms(every 2 months)