Bacterial Vaginosis
Conditions
Brief summary
Randomized, double blind, positive drug parallel comparison, multi-centre clinical trial to assess the Efficacy and Safety of Clindamycin palmitate hydrochloride dispersible tablet for the treatment of bacterial vaginosis
Detailed description
Treatment group: Clindamycin palmitate hydrochloride dispersible tablet . Control group: Metronidazole Tablet.
Interventions
DRUGClindamycin palmitate hydrochloride dispersible tablet
300mg, oral after meal, twice daily, a total of 7days
400mg, oral after meal , twice daily, a total of 7days
Sponsors
Guangzhou Yipinhong Pharmaceutical CO.,LTD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
1. Patients clinically diagnosed with bacterial vaginosis, should meet the following criteria: vaginal Gram stain integration score (Nugent score) ≥7 points 2. Female patients aged 18 to 55 years old. 3. Patients signed the Informed Consent Form(ICF).
Exclusion criteria
1. Patients with vulvovaginitis caused by other infectional reasons such as vaginitis vulvovaginal candidiasis, trichomoniasis vaginitis. 2. Patients received systemic or vaginal antimicrobial therapy in a week before enrolled. 3. Patients with other vaginal or vulvar disorders which could effect the evaluation of efficacy. 4. Pregnant or lactating patients. 5. Menopausal women. Menopause definition: perimenopausal women stop menstruations for a year. 6. Women with diabetes. 7. Dependent on alcohol and could not prohibit during the study period. 8. Women with liver and kidney disfunction, blood disorders, mental illness or other serious diseases. 9. Women allergic to metronidazole, clindamycin. 10. With poor compliance.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Nugent score | From the first day of randomization to 4-10 and 23-33 days after the end,expected to be up to 33 days.Evaluate changes from baseline to the end of the study. | score of Vaginal secretions for Gram stain |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The pH of vaginal secretions; | From the first day of randomization to 4-10 and 23-33 days after the end,expected to be up to 33 days.Evaluate changes from baseline to the end of the study. | pH value |
| Leucorrhea routine examination | From the first day of randomization to 4-10 and 23-33 days after the end,expected to be up to 33 days.Evaluate changes from baseline to the end of the study. | Vaginal cleanliness |
| Itching score | From the first day of randomization to 4-10 and 23-33 days after the end,expected to be up to 33 days.Evaluate changes from baseline to the end of the study. | The severity of vulvar itching |
| Vaginal secretions | From the first day of randomization to 4-10 and 23-33 days after the end,expected to be up to 33 days.Evaluate changes from baseline to the end of the study. | The amount of secretions |
Countries
China
Contacts
Primary ContactZhaohui Liu, MD
Backup ContactDai Zhang, MD
Outcome results
None listed