A randomized, comparative clinical trial to evaluate the safety and efficacy of the vaginal cleaning effect of plasma-activated water using a plasma vaginal irrigator(WOMEN CARE®) in female patients with suspected vaginitis
Not Applicable
Completed
- Conditions
- Diseases of the genitourinary system
- Registration Number
- KCT0007202
- Lead Sponsor
- Roen Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 94
Inclusion Criteria
1) Women over the age of 19 with sexual experience
2) Patient with suspected vaginitis
Exclusion Criteria
1) Those who have an intrauterine device
2) Those who need immediate drug prescription based on the examiner's judgment that the quality of life of the patient is significantly reduced due to vaginitis accompanied by
severe redness and itching
3) Patient with suspected uterine adnexitis or endometritis
4) Patient with suspected pelvic inflammatory disease
5) Those who took antibiotics or antifungals during the clinical trial period
6) Pregnant or lactating women
7) In case it is judged inappropriate to participate in this clinical study according to the judgment of other researchers
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cleaning efficacy of vaginitis causative bacteria (bacteria, fungus, virus)
- Secondary Outcome Measures
Name Time Method Proportion of patients whose detection amount of vaginitis causative bacteria (bacteria, fungus, virus) decreased as a result of PCR test, Gram stain test, and bacterial culture test;Medical device satisfaction;Adverse events / Serious adverse events