Treatment for Aerobic Vaginitis by Using Bofukang Vaginal Suppository

Study Overview
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Brief Summary
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Aerobic vaginitis was treated by using Baofukang Suppository 7 days group or Baofukang Suppository 14 days group.To evaluate the efficacy and safety after treatment.

Detailed Description
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Aerobic vaginitis was treated by using Baofukang Suppository 7 days group or Baofukang Suppository 14 days group. Group 1: Baofukang Suppository (1.74g), for vaginal use, 2 capsules per night for 7 days. Group 2: Baofukang Suppository (1.74g), for vaginal use, 2 capsules per night for 14 days. The efficacy and safety will be evaluated 7 14 days after treatment and 35 42 days after treatment.

Official Title
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Medical Ethics Committee of Peking University Shenzhen Hospital

Conditions
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Vaginitis

Intervention / Treatment
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* Drug: Experimental: Baofukang Suppository 7 days
* Drug: Experimental: Baofukang Suppository 14 days


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aerobic vaginitis diagnosed based on present ： Vaginal dischareg ; pH > 4.5; Donders score≥3; Exclusion Criteria: Patients with other vaginitis, cervical erosion, or suspected gonorrhea, herpes simplex virus infection and other vulvar diseases; Patients received systemic or vaginal antifungal or antibiotic treatment within two weeks before admission. Pregnancy, lactation and intentional pregnancy; Women with liver and kidney dysfunction, low immune function, diabetes, psychosis or other serious diseases; Allergic constitution and patients allergic to drug ingredients in this study; Those 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Baofukang Suppository 7 days<br>Baofukang Suppository (1.74g), for vaginal external use, 2 capsules per night for 7 days | Drug: Experimental: Baofukang Suppository 7 days<br>* Experimental: Baofukang Suppository 7 days<br>* Other names: Baofukang Suppository 7 days;|
| Experimental: Baofukang Suppository 14 days<br>Baofukang Suppository (1.74g), for vaginal external use, 2 capsules per night for 14days | Drug: Experimental: Baofukang Suppository 14 days<br>* Experimental: Baofukang Suppository 14 days<br>* Other names: Baofukang Suppository 14 days;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cure rate | A vaginal smear composite Donders score of 1 to 2 represents normality. A score of more than 2 is aerobic vaginitis. There are four variables(Lactobacillary; leucocytes; toxic leukocytes; parabasal cells; background flora). Detail see references Links. | First week after treatment | 
| Cure rate | A vaginal smear composite Donders score of 1 to 2 represents normality. A score of more than 2 is aerobic vaginitis. There are four variables(Lactobacillary; leucocytes; toxic leukocytes; parabasal cells; background flora).Detail see folowing references. | First month after the treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Side affect | Number of Participants Experiencing AEs Following the First Dose of the Study Product | First week after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aerobic vaginitis, Treatment