Influence of Black Cohosh (Cimicifuga Racemosa) Use by Postmenopausal Women on Total Hepatic Perfusion and Liver Functions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Effect on hepatic perfusion and liver functions
研究概览
简要总结
Black Cohosh extract is a form of phytoestrogen (estrogen of plant origin) that is effective in controlling bothersome hot flushes, while avoiding the dangers of using hormones. Recent case reports pointed to potential toxicity of black cohosh on the liver. The investigators are trying to verify or refute such allegations.
详细描述
The aim of this prospective longitudinal clinical trial is to evaluate changes in total hepatic blood flow and liver functions among postmenopausal women using black cohosh (cimicifuga racemosa) extract for twelve consecutive months for relief of vasomotor symptoms.
Prior to using a daily dose of 40 mg of a dry extract preparation of cimicifuga racemosa (Klimadynon®) and twelve months after, total hepatic blood flow will be assessed by color Doppler ultrasound. Moreover, prothrombin time & concentration, serum albumin, bilirubin, gamma-glutamyl transferase (GGT), alkaline phosphatase (ALP), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) will also be measured.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •an age over 40 years
- •with a lapse of one year after the last menstruation
- •symptomatic women without gynecological illness
- •after naturally occurring menopause
- •had never used hormonal therapy or had stopped using them for >6 months
- •accepting to participate after receiving adequate description of the study
- •accessible for regular follow-up.
排除标准
- •vaginal bleeding
- •active or chronic liver disease and /or abnormal liver functions
- •present or past thromboembolic disease
- •present or past neoplasia of the breast or uterus
- •an endometrial thickness >5 mm by TVS
- •use of alternative or complementary medicines or herbs for menopausal symptoms within the previous three months
研究组 & 干预措施
black cohosh extract, liver
100 postmenopausal women
干预措施: Cimicifuga racemosa extract for the group (Drug)
结局指标
主要结局
Effect on hepatic perfusion and liver functions
时间窗: 12 months
次要结局
- Efficacy and tolerability(12 months)