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

Chang Gung Medical Foundation

Status: Completed

Conditions: Vaginal Infection; Human Papillomavirus

Treatments: Dietary Supplement: U-relax

Study type: Interventional

Funder types: Other

Identifiers

NCT01599416

CGMH-O&G-201101TF01

99-0948A3 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: Female

Ages: 30 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• female
• 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

Exclusion criteria

• cervical intraepithelial neoplasia before conization
• cervical cancer patient
• with GI surgery
• GI dysfunction
• need for long-term antibiotics treatment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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80 participants in 2 patient groups, including a placebo group

U-relax Group

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: U-relax

Placebo Group

Placebo Comparator group

Description:

Day 1-5: take two capsuals of oral placebo everyday before sleep Day 6-360: take one capsual of oral placebo everyday before sleep

Treatment:

Dietary Supplement: U-relax