NCT04694027Unknown4 期
Omega-3 Fatty Acids Plus Vitamin E Cosupplementation Versus Vitamin E in Fibrocystic Breast Patient
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- improvement of pain severity
研究概览
简要总结
to identify the effect of omega-3 plus vitamin E cosupplementation on mastalgia in patients with FCC and to compare its effect with that of vitamin E only.
详细描述
120 patients will be enrolled in the study and divided into three groups each group consisted 40 patient then the severity of mastalgia in the three groups before, through and after intervention. Radiological assessment was done before and after the intervention.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •all females with mastalgia aged 18 to 55
排除标准
- •Pregnant and lactating women, patient who had a recent breast abscess or breast drainage, patient used omega-3 and vitamin E supplementation before the trial and postmenopausal women.
研究组 & 干预措施
group a
Active Comparator
will receive omega 3 plus vitamin E
干预措施: Omega 3 fatty acid (Drug)
group a
Active Comparator
will receive omega 3 plus vitamin E
干预措施: VitaE (Drug)
Group b
Active Comparator
will receive vitamin E
干预措施: VitaE (Drug)
结局指标
主要结局
improvement of pain severity
时间窗: 3 months
improvement of pain on visual analogue scale
次要结局
- improvement of radiological finding(3 months)
研究者
Rehab Sabry
assistant lecturer
Cairo University
研究点 (1)
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