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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
Treatment group: Clindamycin palmitate hydrochloride dispersible tablet . Control group: Metronidazole Tablet.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clindamycin palmitate hydrochloride | Active Comparator | Clindamycin palmitate hydrochloride dispersible tablet 300mg, oral after meal, twice daily, a total of 7days |
|
| Metronidazole | Active Comparator | Metronidazole Tablet 400mg, oral after meal , twice daily, a total of 7days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clindamycin palmitate hydrochloride dispersible tablet | Drug | 300mg, oral after meal, twice daily, a total of 7days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Nugent score | score of Vaginal secretions for Gram stain | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The pH of vaginal secretions; | pH value | 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. |
| Leucorrhea routine examination |
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Inclusion Criteria:
Exclusion Criteria:
Patients with vulvovaginitis caused by other infectional reasons such as vaginitis vulvovaginal candidiasis, trichomoniasis vaginitis.
Patients received systemic or vaginal antimicrobial therapy in a week before enrolled.
Patients with other vaginal or vulvar disorders which could effect the evaluation of efficacy.
Pregnant or lactating patients.
Menopausal women.
Menopause definition: perimenopausal women stop menstruations for a year.
Women with diabetes.
Dependent on alcohol and could not prohibit during the study period.
Women with liver and kidney disfunction, blood disorders, mental illness or other serious diseases.
Women allergic to metronidazole, clindamycin.
With poor compliance.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhaohui Liu, MD | Contact | +86-10-66174284 | 23662161@qq.com | |
| Dai Zhang, MD | Contact | +86-10-66174284 |
| Name | Affiliation | Role |
|---|---|---|
| Zhaohui Liu, MD | Peking University First Hospital | Study Chair |
| Shangrong Fan, MD | Peking University Shenzhen Hospital | Principal Investigator |
| Long Sui, MD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University first hospital | Recruiting | Beijing | 100034 | China |
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| Metronidazole Tablet | Drug | 400mg, oral after meal , twice daily, a total of 7days |
|
|
Vaginal cleanliness
| 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. |
| Itching score | The severity of vulvar itching | 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 secretions | The amount of 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. |
| Affiliated Gynecology and Obstetrics Hospital of Fudan University |
| Principal Investigator |
| Ruifang An, MD | First Affiliated Hospital Xi'an Jiaotong University | Principal Investigator |
| ID | Term |
|---|---|
| D016585 | Vaginosis, Bacterial |
| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D014627 | Vaginitis |
| D014623 | Vaginal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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| ID | Term |
|---|---|
| C000489 | clindamycin palmitate |
| D008795 | Metronidazole |
| ID | Term |
|---|---|
| D009593 | Nitroimidazoles |
| D009574 | Nitro Compounds |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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