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A prospective, single-center, randomized, third-party blinded, comparative clinical study to evaluate the efficacy and safety of the plasma-activated water on improving vaginal environment using a plasma vaginal irrigator (WOMEN CARE) in patients with Gardnerella, Ureaplasma

A prospective, single-center, randomized, third-party blinded, comparative clinical study to evaluate the efficacy and safety of the plasma-activated water on improving vaginal environment using a plasma vaginal irrigator (WOMEN CARE) in patients with Gardnerella, Ureaplasma

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0009800
Enrollment
114
Registered
2024-09-26
Start date
2024-10-10
Completion date
Unknown
Last updated
2025-11-17

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 : 1. Screening, assignment, and testing ? Participants in the study will undergo the tests below. - PCR test - Gram staining and bacterial culture test -

Sponsors

Ahn Ladies Clinic
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Patients with vaginitis aged 19 years or older 2. Those who meet at least one of the following criteria - Those with clinical symptoms of bacterial vaginosis - Positive Gardnerella vaginalis in STD PCR test - Positive Ureaplasma in STD PCR test 3. Those who voluntarily decide to participate in this clinical study and are willing to comply with the clinical research protocol

Exclusion criteria

Exclusion criteria: 1. Those who have a history of adverse reactions to standard treatment drugs 2. Those who have an intrauterine device 3. Those who are pregnant 4. Those with intellectual or mental problems that make it difficult to decide on their own whether or not to participate in the study 5. Those without sexual experience 6. Those who have taken antibiotics or antifungal medications within a week 7. Other cases where participation in this clinical study is deemed unsuitable at the discretion of the researcher

Design outcomes

Primary

MeasureTime frame
Percentage of participants with reduced Nugent score in each group—

Secondary

MeasureTime frame
Percentage of participants with reduced detection of STI pathogens as a result of PCR testing in each group;Change in Nugent score in each group;Percentage of participants with reduced Nugent score in each group;Percentage of participants with improved vaginal pH in each group;Percentage of participants with improved vaginal pH in each group;Rate of change in symptom questionnaire scores (individual items and 10 cm VAS) in each group;Rate of change in symptom questionnaire scores (individual items and 10 cm VAS) in each group;Participant satisfaction in each group;Overall symptom improvement (evaluated by participants) in each group;Nugent score in study group;Vaginal pH in study group;Symptom questionnaire scores in study group;Adverse events / Serious adverse events—

Countries

Korea, Republic of

Contacts

Public ContactChanghoon Ahn

Ahn Ladies Clinic

sambul8279@naver.com+82-41-553-7533

Outcome results

None listed

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