NCT01283568Unknown不适用
Phase IV Study of Combined GAMALINE and HIPERICIN for Treating Pre-Menstrual Syndrome and Vasomotor Symptoms
Phytopharm Consulting Brazil1 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2011年1月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 240
- 试验地点
- 1
研究概览
简要总结
GAMALINE is already register for PMS and HIPERICIN as antidepressive drug. Both plant extracts. The investigators will try the mixture and see if the vasomotor symptoms will disappear. The investigators expect that together all symptoms will be covered better than Gamaline alone. The investigators will run for 180 days measuring at T0, T1 and T6 (starting point, 30 days and 180 days).
详细描述
This protocol wants to show the advantages for the mixture GAMALINE 900mg+HIPERICIN 300mg - 2 herbal extracts for PMS treatment against the individual use of GAMALINE
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 25 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •climacteric pre-menopausal women between 45 e 55 anos
- •women between 25 e 44 anos
排除标准
- •Age inferior 25 anos or superior 55 anos and/or decline invitation.
- •Patients pos-menopause
- •Under hormone therapy
- •Thyroid disease
- •Under psychiatric therapy or medication
- •History for allergies and hypersensitivity to one or both extracts
- •Breast feeding or pregnancy
- •No knowledge for writing and/or reading
研究者
研究点 (1)
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