Acupuncture for Vasomotor Symptoms
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 209
- 试验地点
- 3
- 主要终点
- Subjective Hot Flashes
研究概览
简要总结
The primary purpose of this study is to determine the effectiveness of acupuncture for treating vasomotor and other symptoms associated with menopause as acupuncture is generally practiced in the "real world" setting and to obtain a comprehensive assessment of use patterns and symptom relief over time. This study will allow us to determine treatment patterns recommended by practicing acupuncturists, adherence to these treatments, and the effectiveness of different treatment patterns for reducing hot flashes. Results of this study will provide meaningful information to women in terms of number and frequency of acupuncture treatments likely to be needed to reduce hot flashes.
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
- 45 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women experiencing on average 4 Hot Flashes a day
- •Women aged 45-60
- •Peri or Post menopausal Women (No periods for at least 3 months)
排除标准
- •Women who have initiated CAM or non-CAM treatments for hot flashes in the last 4 weeks
- •Women who have changed their dose of a CAM or non-CAM treatments for hot flashes in the last 4 weeks
- •Women who have initiated antidepressants in the last 3 months
- •Women who have changed their dose of an antidepressant in the last 3 months
- •Women who have had acupuncture in the last 4 weeks
- •Women who have received acupuncture from one of the study acupuncturists in the last 6 months will be excluded from the study
- •Women who describe their health as fair or poor are excluded from the study
- •Women who have a diagnosis of Hemophilia
- •Relatives and Co-Workers of the treating acupuncturists
研究组 & 干预措施
Acupuncture
This group will start acupuncture treatments within 3 weeks of consent and continue to receive up to 20 treatments over a six month period. The number of treatments will be jointly determined by the participant and the acupuncturist.
干预措施: Acupuncture (Procedure)
Waitlist
This group of participants will be asked to wait 6 months and will then be allowed to receive acupuncture.
干预措施: Acupuncture (Procedure)
结局指标
主要结局
Subjective Hot Flashes
时间窗: Up to 14 months
Hot Flashes will be monitored via daily diary. This diary will be filled out daily for the first six months (post randomization) of the study and then 1 week per month for the remaining 6 months of the study.
次要结局
- Objective Hot Flashes(3 days)
- Other Symptoms(Up to 14 months)
- Quality of Life(Up to 58 weeks)