Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| CTS-CO-2417 | Registry Identifier | ClinicalTrials.gov |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vaginal Lactobacillus Dual Probiotic Capsules | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vaginal Lactobacillus Dual Probiotic Capsules | Drug | Vaginal Lactobacillus Dual Probiotic Capsules, at the prescribed dose and course of treatment, for regulating vaginal microecology. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Day 21 to Day 30 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Day 15 to Day 18 |
| Bacteriological Cure Rate |
| Measure | Description | Time Frame |
|---|---|---|
| Vaginal Lactobacillus Colonization Rate | Day 21 to Day 30 |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangdong Longchuangji Pharmaceutical Co., Ltd. | Chaozhou | Guangdong | 521000 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D016585 | Vaginosis, Bacterial |
| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D014627 | Vaginitis |
Not provided
Not provided
This study is a multicenter, randomized, double-blind, placebo-controlled phase IIb clinical trial designed to evaluate the efficacy and safety of Vaginal Lactobacillus Dual Probiotic Capsules in the treatment of bacterial vaginosis. A total of 66 subjects are planned to be enrolled and randomized in a 2:1 ratio into either the treatment group or the placebo group. Specifically, 44 subjects in the treatment group will receive Vaginal Lactobacillus Dual Probiotic Capsules (containing 1×10⁸ CFU per capsule), while 22 subjects in the placebo group will receive a placebo.
Not provided
Not provided
This trial employs a double-blind method, meaning that neither the investigator nor the subject knows which treatment the subject is receiving. Both the Vaginal Lactobacillus Dual Probiotic Capsules used in the treatment group and the placebo used in the placebo group are provided by Guangdong Longchuangji Pharmaceutical Co., Ltd. The investigational drug and the control drug are nearly identical in appearance, shape, specification, and dosage.
| Placebo | Drug | Placebo capsule with the same appearance as the study drug, at the same dose and course of treatment as the experimental group. |
|
Bacteriological cure is defined as a Nugent score of less than 4 |
| Day 15 to Day 18 |
| Composite Cure Rate | Comprehensive cure is defined as meeting both clinical cure and bacteriological cure. | Day 15 to Day 18 |
| Bacteriological Cure Rate | Bacteriological cure is defined as a Nugent score of less than 4 | Day 21 to Day 30 |
| Composite Cure Rate | Comprehensive cure is defined as meeting both clinical cure and bacteriological cure. | 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. | 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. | Through study completion, an average of 30 days |
| D014623 |
| Vaginal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |