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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Human Papillomavirus, Vaginal Infection

Intervention / Treatment
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* Dietary Supplement: U-relax


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: U-relax Group: U-relax capsules Day 1-5: take two capsuals of oral U-relax everyday before sleep Day 6-360: take one capsule of oral U-relax everyday before sleep Control Group: Placebo capsules Day 1-5: take two capsuals of oral placebo everyday before sleep Day 6-360: take one capsual of oral placebo everyday before sleep
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: U-relax Group<br>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 | Dietary Supplement: U-relax<br>* Oral U-relax Day 1-5: 2 capsuals before sleep Day 6-360: 1 capsual before sleep<br>* Other names: GR-1 and RC-14;|
| Placebo Comparator: Placebo Group<br>Day 1-5: take two capsuals of oral placebo everyday before sleep Day 6-360: take one capsual of oral placebo everyday before sleep | Dietary Supplement: U-relax<br>* Oral U-relax Day 1-5: 2 capsuals before sleep Day 6-360: 1 capsual before sleep<br>* Other names: GR-1 and RC-14;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vaginal environment health check | PAP Test, general check and health condition questionnaire | up to Day 360 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HPV DNA Index Test Change | HPV DNA Index Test, Health Condition Check | Day 1, Day 360 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oral Probiotics, HPV DNA Index Test, Vaginal infection