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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01599416
• Other study ID #: CGMH-O&G-201101TF01
• Secondary ID: 99-0948A3
• Status: Completed
• Phase: N/A
• First received: May 7, 2012
• Last updated: January 4, 2018
• Start date: June 2011
• Est. completion date: December 2013

Study information

• Verified date: April 2012
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Human Papillomavirus
• Infection
• Vaginal Infection

Intervention

Dietary Supplement:
• U-relax
Oral U-relax Day 1-5: 2 capsuals before sleep Day 6-360: 1 capsual before sleep

Locations

Country	Name	City	State
Taiwan	Kaohsiung Chang Gung Memorial Hospital	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

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