The Efficacy and Safety Study of Clindamycin Palmitate Hydrochloride Dispersible Tablet Treatment of Bacterial Vaginosis

Study Overview
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Brief Summary
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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

Detailed Description
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Treatment group: Clindamycin palmitate hydrochloride dispersible tablet . Control group: Metronidazole Tablet.

Official Title
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The Efficacy and Safety Study of Clindamycin Palmitate Hydrochloride Dispersible Tablet for the Treatment of Bacterial Vaginosis

Conditions
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Bacterial Vaginosis

Intervention / Treatment
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* Drug: Clindamycin palmitate hydrochloride dispersible tablet
* Drug: Metronidazole Tablet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients clinically diagnosed with bacterial vaginosis, should meet the following criteria: vaginal Gram stain integration score (Nugent score) ≥7 points Female patients aged 18 to 55 years old. Patients signed the Informed Consent Form(ICF). 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Clindamycin palmitate hydrochloride<br>Clindamycin palmitate hydrochloride dispersible tablet 300mg, oral after meal, twice daily, a total of 7days | Drug: Clindamycin palmitate hydrochloride dispersible tablet<br>* 300mg, oral after meal, twice daily, a total of 7days<br>* Other names: No other Names;|
| Active Comparator: Metronidazole<br>Metronidazole Tablet 400mg, oral after meal , twice daily, a total of 7days | Drug: Metronidazole Tablet<br>* 400mg, oral after meal , twice daily, a total of 7days<br>* Other names: No other Names;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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. |