NCT01599416

Influence of U-relax on Vaginal Health Promotion and HPV DNA Test Change From Positive to Negative

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Chang Gung Memorial Hospital · Academic / Other
• Sex: Female
• Age: 30 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Human Papillomavirus
• Vaginal Infection

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	U-relax	Oral U-relax Day 1-5: 2 capsuals before sleep Day 6-360: 1 capsual before sleep

Timeline

• Start date: 2011-06-01
• Primary completion: 2013-06-01
• Completion: 2013-12-01
• First posted: 2012-05-16
• Last updated: 2018-01-05

Locations

1 site across 1 country: Taiwan