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A prospective, single-center, randomized, third-party blinded(evaluator), 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 Ureaplasma, Mycoplasma

A prospective, single-center, randomized, third-party blinded(evaluator), 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 Ureaplasma, Mycoplasma

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0009949
Enrollment
114
Registered
2024-11-26
Start date
2024-11-11
Completion date
Unknown
Last updated
2024-12-09

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 - Bacterial culture test - Vaginal pH test 2

Sponsors

Kim’s OB&GY 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 - Positive Ureaplasma in STD PCR test - Positive Mycoplasma 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 are pregnant 3. Those with intellectual or mental problems that make it difficult to decide on their own whether or not to participate in the study 4. Those without sexual experience 5. Those who have taken antibiotics or antifungal medications within a week 6. 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 level of vaginitis-causing pathogens (Ureaplasma spp., Mycoplasma spp.) as a result of culture test in each group

Secondary

MeasureTime frame
Percentage of participants with reduced detection of STI pathogens as a result of PCR testing 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;Participant satisfaction in each group;Overall symptom improvement (evaluated by participants) in each group;Culture test results 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 ContactMikyung Kim

Kim’s OB&GY Clinic

sambul8279@naver.com+82-2-402-2700

Outcome results

None listed

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