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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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0007202
Enrollment
94
Registered
2022-04-15
Start date
2021-09-25
Completion date
Unknown
Last updated
2022-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Medical Device, Procedure/Surgery : Participants in the study will perform the following tests before and after cleaning. - PCR test: 12 types of STDs - Gram staining test - Bacterial culture te

Sponsors

Roen Medical Center
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1) Women over the age of 19 with sexual experience 2) Patient with suspected vaginitis

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Cleaning efficacy of vaginitis causative bacteria (bacteria, fungus, virus)

Secondary

MeasureTime frame
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

Countries

Korea, Republic of

Contacts

Public ContactSungwook Song

Roen Medical Center

sambul8279@naver.com+82-32-205-9755

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026