Phase 3 Study Efficacy and Tolerance: The Use of 2 Phytomedicines in Association GAMALINE® 900mg + HIPERICIN® 300mg for the Treatment of Pre-Menstrual Syndrome (PMS) and Vasomotor Symptoms
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- PMS calendar
研究概览
简要总结
2 phytomedicines already in the market: GAMALINE® for premenstrual syndrome and HIPERICIN® as antidepressant will be prescribed together for treating women with Premenstrual Syndrome (PMS) symptoms and vasomotor problems for checking the advantage compared to the GAMALINE® prescription alone.
详细描述
Test with 2 female groups: 25-44 years old (reproductive age) and 45-55 years old (climacteric premenopausal age) complaining about all symptoms related with premenstrual syndrome.
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
- Double (Participant, Care Provider)
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
- •fertile women between 25-44 years old
- •climacteric women between 45-55 years old
排除标准
- •inferior age to 25 years old
- •superior age to 55 years old
- •post-menopausal
- •under hormone therapy
- •thyroid disease
- •under psychiatric therapy or medication
- •history for allergies and/or hypersensitivity to any component
- •breast feeding or pregnancy
- •no knowledge for writing and/or reading
研究组 & 干预措施
GAMALINE® 45-55 years old
Climacteric women with PMS symptoms
干预措施: GAMALINE® (Drug)
GAMALINE® + HIPERICIN® 25-44 years old
Fertile women 24-44 years old with PMS symptoms
干预措施: GAMALINE® + HIPERICIN® (Drug)
GAMALINE® 25-44 years old
Fertile women 24-44 years old with PMS symptoms
干预措施: GAMALINE® (Drug)
GAMALINE® + HIPERICIN® 45-55 years old
Climacteric women with PMS symptoms
干预措施: GAMALINE® + HIPERICIN® (Drug)
结局指标
主要结局
PMS calendar
时间窗: 240 days
Evaluation will run daily during the 240 days, comparing the results before treatment \[60 days (T-2) and 30 days (T-1)\]. Starting point (T0) treatment/under prescription, till 180 days treatment (T6).
LAB Tests
时间窗: T0 T1 and T6
Blood sample tests before T0 (all arms), after T1 (30 days only for experimental group) and end of T6 (after 180 days of prescription for all arms)
次要结局
- WHOQOL(06 months)