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
30 Years
65 Years
Female
Human Papillomavirus, Vaginal Infection
Trial Information
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
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.
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Outcome Measure:
Vaginal environment health check
Outcome Description:
PAP Test, general check and health condition questionnaire
Outcome Time Frame:
up to Day 360
Safety Issue:
Yes
Principal Investigator
Yu-Che Ou, MD
Investigator Role:
Study Director
Investigator Affiliation:
CGMH
Authority:
Taiwan: Institutional Review Board
Study ID:
CGMH-O&G-201101TF01
NCT ID:
NCT01599416
Start Date:
June 2011
Completion Date:
December 2013
Related Keywords:
- Human Papillomavirus
- Vaginal Infection
- Oral Probiotics
- HPV DNA Index Test
- Vaginal infection
Name | Location |
|---|
