Traditional Chinese Moxibustion for Primary Dysmenorrhea
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 152
- 试验地点
- 1
- 主要终点
- change from baseline in menstrual pain intensity measured by VAS at 6 months
研究概览
简要总结
Hypothesis: Moxibustion is effective for managing primary dysmenorrhea. Aim: To attest the effectiveness and safety of moxibustion for primary dysmenorrhea. Design: A randomized controlled trial. 152 participants will be included. Two arms: moxibustion treatment group and ibuprofen control group.
详细描述
There is no convincing evidence for the efficacy of moxibustion for primary dysmenorrhea, due to low methodologic quality and small sample size. The investigators designed the random clinical trial to investigates the effectiveness of moxibustion in treating primary dysmenorrhea, the purpose of this study is to provide the research base of moxibustion efficacy. The investigators also examined the acceptability and any adverse effects associated with the use of moxibustion.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 13 Years 至 35 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of Guidelines of Primary dysmenorrhea clinical by the Society of Obstetricians and Gynaecologists of Canada
- •Menstrual cycle is regular (28±7) days
- •Syndrome differentiation of Traditional Chinese Medicine: Congealing cold-damp and Qi-stagnation and blood stasis
- •Mean value of ≥40mm during last 3 months
- •Informed consent form must be signed by patient or lineal relative
排除标准
- •Patients with secondary dysmenorrhea, which is caused by endometriosis, pelvic inflammation, myoma of uterus and so on
- •Patients who are unconscious and psychotic
- •Patients with serious primary illness or diseases of cardiovascular, liver, renal, gastrointestinal, hematological systems and so on
- •Patients take prostaglandin synthetase inhibitors (PGSI) 2 weeks before inclusion
- •Pregnant women or women in lactation
研究组 & 干预措施
Moxibustion treatment group
Apply traditional acupuncture to prevent the dysmenorrhea according to traditional Chinese medicine theory
干预措施: moxibustion (Device)
Medicine control group
Ibuprofen Sustained Release Capsules will be penetrated for dysmenorrhea
干预措施: Ibuprofen Sustained Release Capsules (Drug)
结局指标
主要结局
change from baseline in menstrual pain intensity measured by VAS at 6 months
时间窗: at baseline, 1st, 2nd, 3rd, 4th, 5th, 6th menstrual cycle after inclusion
to assess the degree of dysmenorrhea
次要结局
- Laboratory index-1(at baseline, 4th menstrual cycle after inclusion)
- Laboratory Index-4(at baseline, 4 menstrual cycles after inclucion)
- Laboratory Index-2(at baseline, 4 menstrual cycles after inclusion)
- Laboratory Index-5(at baseline, 4 menstrual cycles after inclusion)
- Cox Menstrual Symptom Scale Cox Menstrual Symptom Scale(1st, 2nd, 3rd, 4th, 5th, 6th, 7th menstrual cycle after inclusion)
- Laboratory Index-6(at baseline, 4 menstrual cycles after inclusion)
- Laboratory Index-3(at baseline, 4 menstrual cycles after inclusion)