Human Papillomavirus Clinical Trial
Official title:
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
Verified date | April 2012 |
Source | Chang Gung Memorial Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 80 |
Est. completion date | December 2013 |
Est. primary completion date | June 2013 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 30 Years to 65 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Taiwan | Kaohsiung Chang Gung Memorial Hospital | Kaohsiung |
Lead Sponsor | Collaborator |
---|---|
Chang Gung Memorial Hospital |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Vaginal environment health check | PAP Test, general check and health condition questionnaire | up to Day 360 | |
Secondary | HPV DNA Index Test Change | HPV DNA Index Test, Health Condition Check | Day 1, Day 360 |
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