Randomized, Double-blind, Placebo-controlled Study ,Oral U-relax in the Influence of the Vaginal Environment Health Promotion, and the HPV DNA Test Index Change From Positive to Negative on the HPV Infection Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Vaginal environment health check
研究概览
简要总结
The purpose of this study is to understand the effect of using oral U-relax on HPV infected women for vaginal environment health promotion, and the HPV DNA Test Index change from positive to negative. Long-term infection of HPV is associated with cervical cancer. U-relax contains Lactobacillus GR-1 and Lactobacillus RC-14 and has been approved of its benefits on treatment of BV, UTI, IBD and can improve vaginal environment health. Patients with positive result of HPV DNA test have no appropriate and aggressive treatment to reduce the risk of cervical cancer. This clinical trial tries to reveal the influence of oral U-relax and patients with HPV DNA test positive result.
详细描述
This study is a prospective, double blind, randomized clinical trial. Vaginal health screening and HPV DNA Test are carried out from 80 patients with positive HPV DNA Test after conization for 6 months. All these patients will participant this study during the 360-day trial period. All health related conditions will be monitored at the same time.
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
same capsule appearance and bottle without any marks for identification to participants, care providers and investigators except serial numbers
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •age over 30
- •PAP Test with NEGATIVE FOR INTRAEPITHELIAL LESION OR MALIGNANCY result
- •HPV DNA Index Test with POSITIVE result after conization for 6 months
- •not pregnant
排除标准
- •cervical intraepithelial neoplasia before conization
- •cervical cancer patient
- •with GI surgery
- •GI dysfunction
- •need for long-term antibiotics treatment
研究组 & 干预措施
U-relax Group
Day 1-5: take two capsuals of oral U-relax everyday before sleep Day 6-360: take one capsual of oral U-relax everyday before sleep
干预措施: U-relax (Dietary Supplement)
Placebo Group
Day 1-5: take two capsuals of oral placebo everyday before sleep Day 6-360: take one capsual of oral placebo everyday before sleep
干预措施: U-relax (Dietary Supplement)
结局指标
主要结局
Vaginal environment health check
时间窗: up to Day 360
PAP Test, general check and health condition questionnaire
次要结局
- HPV DNA Index Test Change(Day 1, Day 360)