Black Cohosh Therapy for Menopause-Related Anxiety
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Score on Hamilton Anxiety Rating Scale
研究概览
简要总结
This study will determine the effectiveness of the herb black cohosh for treating menopause-related anxiety symptoms in women.
Study hypotheses: 1) Black cohosh will have a superior anti-anxiety effect compared to placebo. 2) Black cohosh will have a comparable safety profile to that of placebo.
详细描述
During menopause, up to 90% of women will experience symptoms of anxiety, such as nervousness, irritability, fatigue, muscle aches, depression, and low libido. Concern over the safety and effectiveness of hormone replacement therapy for relieving these symptoms has caused many women to seek alternative medical treatments. Data suggest that black cohosh has a direct effect on the neurotransmitters and receptors involved in anxiety. This study will determine whether black cohosh can effectively treat anxiety symptoms in menopausal women.
This study will last 12 weeks. Participants will be randomly assigned to receive either black cohosh or placebo daily for the duration of the study. Self-report scales will be used to assess participants' anxiety symptoms and quality of life at the beginning and end of the study.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Currently experiencing menopause or postmenopausal
- •Have symptoms of menopause-related anxiety
排除标准
- •Any form of generalized anxiety disorder (GAD) unrelated to menopause
- •Onset of GAD at least 3 years prior to menopause or at least 5 years after menstruation has stopped
- •Alcohol or drug dependence within 3 months prior to study entry
- •Allergy to black cohosh
- •History of hormone replacement therapy
- •Current use of vaginal estrogen cream or phytoestrogens
- •Current use of tranquilizers, antidepressants, or antianxiety therapies
- •Abnormal uterine bleeding
- •History of estrogen-dependent cancer
- •History of endometrial hyperplasia (abnormal increase in cells) or endometrial cancer
- •Rapidly growing uterine fibroids
- •Abnormal finding upon gynecological examination that would interfere with the study
- •Abnormal breast examination or mammogram
- •Any unstable medical condition
结局指标
主要结局
Score on Hamilton Anxiety Rating Scale
时间窗: 12 Weeks
次要结局
- Quality of life and functional outcome ratings(12 Weeks)