A prospective, multi-center, randomized and comparative clinical study to evaluate the efficacy and safety of the plasma-activated water on vaginitis-causing bacteria, fungi, viruses and improving vaginal environment 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

KCT0009731

Enrollment

288

Registered

2024-08-28

Start date

2024-07-26

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 -

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Person over the age of 19 2. Patients with suspected vaginitis 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

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

Secondary

Measure	Time 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	—

Measure

Time 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 ContactHyejin Cho

Honest Women's Clinic

pamina73@hanmail.net+82-2-782-7005

Outcome results