NCT02098928已完成不适用
Multicenter Randomized Controlled Trial on Comparison of Efficacy Between Hand Acupuncture and Electro-acupuncture in Treatment of Menopausal Hot Flashes Symptoms
The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine1 个研究点 分布在 1 个国家目标入组 242 人开始时间: 2014年4月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 242
- 试验地点
- 1
- 主要终点
- Change from Baseline in average scores of 24-hour hot flashes symptoms at 32 weeks
研究概览
简要总结
Main objective: to compare the effects of hand-acupuncture and electro-acupuncture stimulation on the baking heat symptoms of menopause Secondary objective: to evaluate the safety and acceptability of hand acupuncture and electroacupuncture stimulation
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •in past of 12 months in, menstrual cycle not rules, menstrual ahead of or wrong Hou ≥ 7 days (menopause transition period early); in past of 12 months in, at least shedding had 2 a menstrual cycle, or amenorrhea over 60 days, but ≤ November (menopause transition period late); last once menstrual to stopped by Hou 3 years within (menopause 3 years within patients)
- •Menopause-related symptoms: baking heat, sweating, insomnia, migraines,irritability, sore vagina, sexual intercourse and so on
- •40-55 years
- •Baseline scorch score ≥ 6 points
- •without hormone therapy indications for mandatory, such as during menopause, osteoporosis mobility
- •volunteered for this study, and sign the consent form
排除标准
- •test within 3 months before the menstrual cycle rules
- •nearly 4 weeks applied estrogen, SSRIs, soy isoflavones, progesterone, vitamin e, or Black Cohosh
- •diameter greater than 4cm fibroid ovarian cyst, ovarian or after hysterectomy
- •disease history of chemotherapy or who are undergoing chemotherapy
- •unexplained vaginal bleeding
- •coagulation disorders or taking anticoagulant drugs such as warfarin, heparin
- •suffered from skin diseases like eczema, psoriasis, etc
- •severe hepatic and renal insufficiency
- •yet controlled high blood pressure, diabetes, or thyroid disease
- •diabetic nerve damage, cancer and mental illnesses (including depression)
- •wishes are in pregnancy or pregnancy or breastfeeding
- •long-term use of sedatives or antidepressants
- •long-term smoking and alcoholism
- •installed pacemaker or artificial joints
结局指标
主要结局
Change from Baseline in average scores of 24-hour hot flashes symptoms at 32 weeks
时间窗: into the group, into the group after the 4th, 8, 20 and 32 weeks.
The average scores of 24 hours hot flashes integration consists of integrating the hot flashes times and hot flashes extent, hot flashes degree of mild, moderate and severe hot flashes three categories. Recorded by diary cards of hot flashes symptoms diary cards.
次要结局
- the serum levels of sex hormones(into the group, into the group after the 8th week; secondary evaluation points: into the group after the 20th week.)
- Scores of the Self-Rating Anxiety Scale（SAS）(into the group, into the group after the 4th, 8, 20 and 32 weeks.)
- Scores of the Self-rating depression scale（SDS）(into the group, into the group after the 4th, 8, 20 and 32 weeks.)
- Scores of menopause rating scale（MRS）(into the group, into the group after the 4th, 8, 20 and 32 weeks.)
- Scores of Menopause-Specific Quality of Life Questionnaire （MENQOL）(into the group, into the group after the 4th, 8, 20 and 32 weeks.)
研究者
研究点 (1)
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