The objective of the study is to confirm the pharmacological mechanism and evaluate the efficacy and safety after HUDC-VT administration compared to placebo in patients with bacterial vaginosis. Vaginitis in adult women is extremely common and it often results in marked suffering. Epidemiologic studies indicate the high prevalence of vaginitis and the large number of causes in US. The broad-spectrum antibiotics such as metronidazole have been used as a treatment of vaginitis.However, it is not desirable using of these antibiotics caused appearance of resistant bacterium and killing normal bacterium including lactobacillus. In addition, it has been reported that long term treatment of antibiotics can be caused body toxicity through absolution by vagina. The product, HUDC\_VT, is a effective and safe vaginal tablet composed glucose and sodium chloride for treatment of vaginitis by preserving healthy condition in vagina.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
150
Vaginal administration, two tablets once a day for 7 days
Vaginal administration, two tablets once a day for 7 days
Vaginal administration, two tablets once a day for 7 days
Vaginal administration, two tablets once a day for 7 days
Vaginal administration, two tablets once a day for 7 days
Korea University Guro Hospital
Seoul, Guro-gu, South Korea
RECRUITINGTherapeutic cure rate of bacterial vaginosis at 2 weeks after last treatment
Time frame: at 2 weeks after last treatment
Therapeutic cure rate of bacterial vaginosis at last treatment
Time frame: at 7 days
proportion of patients with Normal Nugent score
Time frame: at 2 weeks after last treatment
proportion of patients with Normal Hay/Ison grade
Time frame: at 2 weeks after last treatment
proportion of patients with Normal Vaginal Fluid pH
Time frame: at 2 weeks after last treatment
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