Ellagic Acid and Annona Muricata May Modulate the Immune Response to High Risk HPV Infection. A Randomized, Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 主要终点
- variation of onco suppressor protein expression from basal values. The expression variations are represented by the different percentage of positive cells
研究概览
简要总结
The purpose of this study is to evaluate whether a supplement in which ellagic acid plus annona muricata are combined, may modulate the immune response to high risk HPV infection. Sixty women will be enrolled in a randomized, controlled study, having a histological diagnosis of L-SIL correlated with high rish HPV types infection. Main outcome measure is the activation of onco suppressor protein by the supplement and secondary outcome is the clearance of HPV infection in the treated group.
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
- None
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women with high risk HPV infection
- •histological diagnosis of L-SIL
排除标准
- •women with no high risk HPV infection
- •women without histological diagnosis of L-SIL
研究组 & 干预措施
supplement
干预措施: ellagic acid + annona muricata (Drug)
not intervention
干预措施: ellagic acid + annona muricata (Drug)
结局指标
主要结局
variation of onco suppressor protein expression from basal values. The expression variations are represented by the different percentage of positive cells
时间窗: 6 months
次要结局
- clearance of the HPV infection(6 months)
研究者
Rosario D'anna
associate professor
University of Messina