A Multicentered RCT Study of the Efficacy and Safety of an Extract of Cimicifuga Foetida L. for the Treatment of Climacteric Symptoms of Chinese Women
试验速览
- 阶段
- 4 期
- 入组人数
- 288
- 试验地点
- 13
- 主要终点
- Change of scores of Kupperman Index before and after the treatment
研究概览
简要总结
This study is designed to determine whether an extract of Cimicifuga Foetida L. is safe and efficacious to relieve the climacteric symptoms of Chinese women
详细描述
Extracts of Cimicifuga Racemosa (black cohosh) have been widely used in North America and Europe for decades for the treatment of menopause related problems, either as nutritional supplements or as pharmaceutical products. Previous clinical trials had shown that an extract of Cimicifuga Foetida L.(Ximingting, Luyepharm), which was standardized to have similar components of an extract of Cimicifuga Racemosa, was safe and efficacious to relieve the climacteric symptoms and signs in Chinese women who were recruited according to criteria categorized by theory of Traditional Chinese Medicine.We are interested to know whether it may have the same efficacy and safety profiles when judged with method and standard commonly accepted in western medicine.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Having climacteric symptoms with hot flushes >= 3 time per day
- •Score of Kupperman Index at baseline >= 20
- •In addition to these criteria, women who had menopause longer than 2 months but less than 12 months, with FSH > 15U/L were enrolled into the perimenopausal group. Women having menopause longer than 12 months but less than 5 years, with FSH >= 40U/L and E2 <= 30pg/ml, were assigned into early staged postmenopausal group.
排除标准
- •Having history of hysterectomy
- •Having HRT within 6 weeks
- •Having other drugs or nutritional supplements of relieving climacteric symptoms within one week
- •Having psychological counseling within one week
- •Having medical history of estrogen-dependent tumors
- •The result of pap smear exam at stage III and above
- •Having an uterine leiomyoma lager than 4 cm
- •The endometrial thickness lager than 0.5 cm
- •Having abnormal cardiac, liver or kidney functions
- •Having abnormal thyroid function
- •Having hypertension, diabetes and coronary heart diseases that were not under control
- •Pregnant or suspected pregnant woman
- •Having severe mental disorders that inhibit to understand the research purpose
- •Other conditions the investigators believed not suitable for enrollment
研究组 & 干预措施
A1
perimenopausal women
干预措施: an extract of Cimicifuga Foetida L. (Drug)
A2
perimenopausal women
干预措施: placebo (Drug)
B1
early staged postmenopausal women
干预措施: an extract of Cimicifuga Foetida L. (Drug)
B2
early staged postmenopausal women
干预措施: placebo (Drug)
结局指标
主要结局
Change of scores of Kupperman Index before and after the treatment
时间窗: 3 months
次要结局
- Change of scores of Menopause Rating Scale before and after the treatment(3 months)