NCT02032862终止4 期
Multicentric, Randomized, Double Blind Study for Assessment of Efficacy and Tolerability of Sage Tablets Compared to Placebo in Menopausal Patients With Hot Flushes and Sweating
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- A. Vogel AG
- 入组人数
- 107
- 试验地点
- 2
- 主要终点
- Change from Baseline Hyperhidrosis Disease Severity Scale
研究概览
简要总结
Sage tablets ( 3400 mg extract from fresh sage leaves, DER 1:17) in a once daily application over 12 treatment weeks are compared against placebo in 200 menopausal patients with ≥ 5 hot flushes daily and a Hyperhidrosis Scale score ≥ 2
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
- 50 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Menopausal since ≥ 1 year
- •≥ 5 hot flushes /24 hours
- •Hyperhidrosis Scale score ≥ 2
排除标准
- •Affections like asthma, COPD, depression, diabetes, epilepsy, hyper- and hypothyreosis, malign tumours
结局指标
主要结局
Change from Baseline Hyperhidrosis Disease Severity Scale
时间窗: Week 12
次要结局
- Change from Baseline Modified Dem Tect(Week 12)
- Change from Baseline Menopause Rating Scale / MRS(Week 12)
研究者
研究点 (2)
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