| Статус: | Recruiting |
| Фаза: | Phase 4 |
| Начало: | 1 июня 2024 г. |
| Окончание: | 1 июня 2026 г. |
| Описание: | The purpose of this clinical trial is to study the efficacy of bovgialuronidase azoximere in the treatment and duration of recurrence-free course of bacterial vaginosis in women of reproductive age. The main questions it aims to answer are: - Is bovgialuronidase azoximer able to destroy G. vaginalis associated biofilms of the vaginal epithelium - use of bovgialuronidase azoximer together with Metronidazole increases the effectiveness of treatment of bacterial vaginosis. - use of azoximers bovgialuronidase together with Metronidazole increases the duration of relapse-free course of bacterial vaginosis. Participants in the experimental and control group will be: - Amsel criteria assessment - Colpotest-PH (vaginal acidity) - aminotest with 10% KOH solution ("fish odor") - microscopic examination of vaginal discharge - Bacteriologic culture of vaginal discharge - Polymerase chain reaction of epithelial cell scrapings from the vagina - electron microscopy of vaginal epithelial cell scrapings Participants in the main group will be given the drug Bovgialuronidase azoximer and Metronidazole. Participants in the control group: Metronidazole. Researchers will compare the experimental and control groups to see if there are differences after treatment in biofilm structure, treatment efficacy, and duration of recurrence-free survival. |
| смотреть на ClinicalTrials.gov |
| Статус: | Recruiting |
| Фаза: | Phase 4 |
| Начало: | 1 июня 2024 г. |
| Окончание: | 1 июня 2026 г. |
| Описание: | The purpose of this clinical trial is to study the efficacy of bovgialuronidase azoximere in the treatment and duration of recurrence-free course of bacterial vaginosis in women of reproductive age. The main questions it aims to answer are: - Is bovgialuronidase azoximer able to destroy G. vaginalis associated biofilms of the vaginal epithelium - use of bovgialuronidase azoximer together with Metronidazole increases the effectiveness of treatment of bacterial vaginosis. - use of azoximers bovgialuronidase together with Metronidazole increases the duration of relapse-free course of bacterial vaginosis. Participants in the experimental and control group will be: - Amsel criteria assessment - Colpotest-PH (vaginal acidity) - aminotest with 10% KOH solution ("fish odor") - microscopic examination of vaginal discharge - Bacteriologic culture of vaginal discharge - Polymerase chain reaction of epithelial cell scrapings from the vagina - electron microscopy of vaginal epithelial cell scrapings Participants in the main group will be given the drug Bovgialuronidase azoximer and Metronidazole. Participants in the control group: Metronidazole. Researchers will compare the experimental and control groups to see if there are differences after treatment in biofilm structure, treatment efficacy, and duration of recurrence-free survival. |
| смотреть на ClinicalTrials.gov |
| Статус: | Recruiting |
| Фаза: | Phase 4 |
| Начало: | 1 июня 2024 г. |
| Окончание: | 1 июня 2026 г. |
| Описание: | The purpose of this clinical trial is to study the efficacy of bovgialuronidase azoximere in the treatment and duration of recurrence-free course of bacterial vaginosis in women of reproductive age. The main questions it aims to answer are: - Is bovgialuronidase azoximer able to destroy G. vaginalis associated biofilms of the vaginal epithelium - use of bovgialuronidase azoximer together with Metronidazole increases the effectiveness of treatment of bacterial vaginosis. - use of azoximers bovgialuronidase together with Metronidazole increases the duration of relapse-free course of bacterial vaginosis. Participants in the experimental and control group will be: - Amsel criteria assessment - Colpotest-PH (vaginal acidity) - aminotest with 10% KOH solution ("fish odor") - microscopic examination of vaginal discharge - Bacteriologic culture of vaginal discharge - Polymerase chain reaction of epithelial cell scrapings from the vagina - electron microscopy of vaginal epithelial cell scrapings Participants in the main group will be given the drug Bovgialuronidase azoximer and Metronidazole. Participants in the control group: Metronidazole. Researchers will compare the experimental and control groups to see if there are differences after treatment in biofilm structure, treatment efficacy, and duration of recurrence-free survival. |
| смотреть на ClinicalTrials.gov |