Clinical study to evaluate the efficacy of HUDC_VT in patients with bacterial vaginosis
- Conditions
- Certain infectious and parasitic diseases
- Registration Number
- KCT0002268
- Lead Sponsor
- Koera University Guro Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 150
1. Fertile women
2. Clinical diagnosis of bacterial vaginosis with criteria on below (3 out of 4 fulfilled criteria)
- light gray adherent vaginal discharge
- pH =4.5
- Presence of clue cells =20%
- Positive "10% Potassium Hydroxide Whiff test"
3. Nugent Score = 4
1. Pregnant or breast-feeding patient or planning pregnancy
2. Patient with candidiasis, Chlamydia trachomatis, Trichomonas vaginalis, Neisseria gonorrhoeae or Herpes simplex virus infection
3. Patient who received antifungal or antimicrobial therapy (systemic or intravaginal) within 30 days of randomization
4.Any condition or circumstance that would interfere with analysis of study results
5. Patient who have a plan to treat other disease (e.g cervical carcinoma) during clinical study period
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Therapeutic cure rate of bacterial vaginosis at at 2 weeks after last treatment
- Secondary Outcome Measures
Name Time Method Therapeutic cure rate of bacterial vaginosis at last treatment ;proportion of patients with Normal Nugent score ;proportion of patients with Normal Hay/Ison grade ;proportion of patients with Normal Vaginal Fluid pH