Treatment of Climacteric Symptoms With Ovaria Comp - A Prospective Randomized Placebo Controlled Doubleblind Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Climacteric symptoms
研究概览
简要总结
The purpose of this study is to determine whether ovaria comp. is effective in relieving climacteric symptoms.
详细描述
Complementary treatments for climacteric symptoms are used by many women although their efficacy and safety is mostly unproven.
The use of the complex homeopathic remedy Ovaria comp. for the relief of climacteric symptoms will be examined in this three-armed intervention trial and measured with the menopause rating scale II before and after each study phase of 12 weeks. Participants will receive the verum during two treatment phases of 12 weeks and the placebo during one treatment phase of 12 weeks in different sequences and are stratified for post- and perimenopausal status.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Climacteric symptoms>=3 Points in Menopause Rating Scale (MRS) II
- •Communication possible
排除标准
- •Hormone replacement therapy within 2 weeks prior to study inclusion
- •Other complementary treatments 7 days before and during the study
- •Climacteric symptoms caused by operation, chemotherapy or hormonal therapy of cancer
- •Allergy to components of the remedy, especially bee poison
研究组 & 干预措施
Group I
ovaria comp 10 Globuli 3 times per day 24 weeks - Placebo 12 weeks
干预措施: ovaria comp 10 globuli 3 times per day 24 weeks (Drug)
Group II
Placebo 12 weeks - ovaria comp 10 globuli 3 times per day 24 weeks
干预措施: ovaria comp 10 globuli 3 times per day 24 weeks (Drug)
Group III
ovaria comp 10 globuli 3 times per day 12 weeks - Placebo 12 weeks - ovaria comp 10 globuli 3 times per day 12 weeks
干预措施: ovaria comp 10 globuli 3 times per day 24 weeks (Drug)
结局指标
主要结局
Climacteric symptoms
时间窗: 12 weeks
sum score of the menopause rating scale (MRS II) before and after 12 weeks of treatment
次要结局
- Climacteric symptoms (vegetative, psychological, urogenital subscales of the MRS II)(12 weeks)
- Follow-up for another 12 weeks of treatment or after cross-over to the placebo group(12+12 weeks)
- Follow-up for cross-over to placebo after 24 weeks of treatment(12+12+12 weeks)
- Diurnal profile of cortisol level before and after treatment phases(12+12+12 weeks)
- Anxiety and depression measured by Hospital Anxiety and Depression Scale (HADS-D) before and after treatment period(12+12+12 weeks)
研究者
Cornelia von Hagens
Principal Investigator
Heidelberg University