NCT06098456已完成2 期
Treatment With Epigallcoatechin Gallate, Hyaluronic Acid, Folic Acid and Vitamin B12 in Women HPV Positive With Abnormal Cytology Tests
Centro di Ricerca Clinica Salentino1 个研究点 分布在 1 个国家目标入组 178 人开始时间: 2023年11月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 178
- 试验地点
- 1
- 主要终点
- Positivity to HPV infection
研究概览
简要总结
The investigators enroll patients with a PAP-test cytology reporting LSIL or ASCUS.
Pateitns undergo HPV-DNA test for screening. Patients are treated with Epigallocatechin galalte, hyaluronic acid, folic acid and Vitamin B12 by oral route.
After three months of treatment PAP-test and HPV-DNA test will be repeated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Positivity to HPV-DNA test
- •PAP-test reporting LSIL or ASCUS
排除标准
- •HPV-related pathologies or complicances apart from LSIL or ASCUS
- •Diagnosis of cancer
研究组 & 干预措施
Treatment
Experimental
The patients in this group undergo treatment with Epigallocatechin gallate 200mg, Hyaluronic acid 50mg, Vitamin B12 1mg and Folic acid 400mcg by oral route once per day.
干预措施: EGCG, FA, HA, B12 (Drug)
结局指标
主要结局
Positivity to HPV infection
时间窗: 3 and 6 months
The outcome consists of the number of negative DNA-test obtained in patients previously positive.
次要结局
- Occurrence of lesions(3 and 6 months)
- Lesions-related symptmos(3 and 6 months)
研究者
ANDREA TINELLI
Professor
Centro di Ricerca Clinica Salentino
研究点 (1)
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