This is a multicenter, randomized, double-blind, placebo-controlled phase IIb clinical study, to evaluate the efficacy and safety of the dual - live Lactobacilli-containing vaginal capsule for the treatment of bacterial vaginosis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
66
Vaginal Lactobacillus Dual Probiotic Capsules, at the prescribed dose and course of treatment, for regulating vaginal microecology.
Placebo capsule with the same appearance as the study drug, at the same dose and course of treatment as the experimental group.
Guangdong Longchuangji Pharmaceutical Co., Ltd.
Chaozhou, Guangdong, China
Clinical Cure Rate
Clinical cure is defined as follows: vaginal secretions return to normal physiological secretions; whiff test is negative; clue cells are negative (i.e., the number of clue cells is less than 20% of the total number of vaginal epithelial cells)
Time frame: Day 21 to Day 30
Clinical Cure Rate
Clinical cure is defined as follows: vaginal secretions return to normal physiological secretions; whiff test is negative; clue cells are negative (i.e., the number of clue cells is less than 20% of the total number of vaginal epithelial cells).
Time frame: Day 15 to Day 18
Bacteriological Cure Rate
Bacteriological cure is defined as a Nugent score of less than 4
Time frame: Day 15 to Day 18
Composite Cure Rate
Comprehensive cure is defined as meeting both clinical cure and bacteriological cure.
Time frame: Day 15 to Day 18
Bacteriological Cure Rate
Bacteriological cure is defined as a Nugent score of less than 4
Time frame: Day 21 to Day 30
Composite Cure Rate
Comprehensive cure is defined as meeting both clinical cure and bacteriological cure.
Time frame: Day 21 to Day 30
Incidence of treatment-emergent adverse events (Safety Evaluation)
A treatment-emergent adverse event was defined as any adverse event occurring on or after the first use of the investigational product, regardless of causality.
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Time frame: Through study completion, an average of 30 days
Incidence of treatment-related adverse events (Safety Evaluation)
A treatment-related adverse events referred to any treatment-emergent adverse events with causal association to the treatment.
Time frame: Through study completion, an average of 30 days