ACTRN12621000499886已完成未知
A Phase II Randomised Double-Blind, placebo-controlled clinical trial evaluating the efficacy of Happy Hormones for menopausal-related symptoms in menopausal women.
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 131
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 40 Years 至 66 Years（—）
- 性别
- Female
入选标准
- •Females between 40 to 66 years of age
- •More than 3 vasomotor symptoms (hot flushes) within a 24-hour period.
- •BMI between 18-35 kg/m2
- •Normal liver and kidney function (within range of the pathology lab used)
- •Ability to speak and understand English sufficiently to comprehend the purpose and risks of the study and to provide consent
排除标准
- •Undiagnosed vaginal bleeding.
- •Use of HRT in the previous three months before baseline
- •Use of any herbal formula that affects hormonal levels in the previous three months before baseline
- •History of alcohol or drug abuse and currently still drinks more than 2 standard glasses of alcohol daily or uses recreational drugs
- •History of or current breast, endometrial or ovarian cancer.
- •Ovariectomy or complete hysterectomy
- •Uncontrolled and or untreated hypertension (defined as systolic blood pressure >160mm Hg and/ or diastolic blood pressure >100 mm Hg.)
- •Uncontrolled psychiatric disorders.
- •Uncontrolled and/or diagnosed medical conditions that may interfere with study medication e.g. Diabetes mellitus, hepatic or renal dysfunction.
研究者
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