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A prospective, randomized and comparative clinical study to evaluate the efficacy and safety of the plasma-activated water on vaginitis and improving vaginal environment using a plasma vaginal irrigator (WOMEN CARE) in female patients with (suspected) vaginitis

A prospective, randomized and comparative clinical study to evaluate the efficacy and safety of the plasma-activated water on vaginitis and improving vaginal environment using a plasma vaginal irrigator (WOMEN CARE) in female patients with (suspected) vaginitis

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0009616
Enrollment
114
Registered
2024-07-10
Start date
2024-08-12
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

None listed

Interventions

Sponsors

Hanyang University Guri Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Person from 19 to 80 years old 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 are suspected of uterine adnexitis, endometritis, or pelvic inflammatory disease 3. Those who have an intrauterine device 4. Those who are pregnant 5. Other cases where participation in this clinical study is deemed unsuitable at the discretion of the researcher

Design outcomes

Primary

MeasureTime frame
Change in Nugent score

Secondary

MeasureTime frame
The percentage of participants with reduced detection of STI pathogens as a result of PCR testing in each group;The percentage of participants with reduced Nugent score in each group;The percentage of participants with reduced Nugent score in each group;The percentage of participants with improved vaginal pH;The percentage of participants with improved vaginal pH;Rate of change in symptom questionnaire scores in each group (individual items and 10 cm Visual Analog Scale);Rate of change in symptom questionnaire scores in each group (individual items and 10 cm Visual Analog Scale);Participant satisfaction in each group;Overall symptom improvement in each group (evaluated by participants);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 ContactKi-Young Ryu

Hanyang University

drryuky@hanmail.net+82-31-560-2344

Outcome results

None listed

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