NCT05448365招募中不适用
The Use of Vitamin D in Combination With Epigallocatechin Gallate, D-chiro-inositol and Vitamin B6 in the Treatment of Women With Uterine Fibroid
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Diameter
研究概览
简要总结
The study will evaluate the impact on uterine fibroids' volume of a combination of natural molecules including Epigallocatechin gallate, Vitamin D, D-chiro-inositol and Vitamin B6.
The patients will be evaluated at baseline and after three months of treatment with placebo or product.
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)
盲法说明
The study will be a double-clind, placebp-controlled trial
入排标准
- 年龄范围
- 30 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •uterine fibroid with diameter greater than or equal to 4cm or multiple fibroids
- •eligible for surgery
- •symptoms like menometrorrhagia or pelvic pain
排除标准
- •currently pregnant or breastfeeding
- •suspect of malignancy
- •diagnosis of cancer
研究组 & 干预措施
EGCG, Vit D, DCI, Vit B6
Active Comparator
Women with uterine fibroids randomized to treatment group
干预措施: Epigallocatechin gallate, Vitamin D, Vitamin B6, D-chiro-inositol (Dietary Supplement)
Placebo
Placebo Comparator
Women with uterine fibroids randomized to placebo group
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Diameter
时间窗: 3 months
Greater diameter of the diagnosed uterine fibroids
次要结局
- Volume(3 months)
- Need for surgery(3 months)
- pVEGF-R(3 months)
- Marker of cellular proliferation(3 months)
研究者
研究点 (2)
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