Treatment for Aerobic Vaginitis by Using Bofukang Vaginal Suppository
ConditionVaginitis
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18-55
SponsorPeking University Shenzhen Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Vaginal dischareg ;
pH > 4.5;
Donders score≥3;
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
Experimental: Baofukang Suppository 7 days
DrugExperimental: Baofukang Suppository 7 days
Experimental: Baofukang Suppository 14 days
DrugExperimental: Baofukang Suppository 14 days
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Baofukang Suppository 7 daysExperimental treatment 1 intervention
Group B: Baofukang Suppository 14 daysExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
First week after treatment2
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.
Time frame
First month after the treatmentSecondary outcomes
1
Side affect
Number of Participants Experiencing AEs Following the First Dose of the Study Product
Time frame
First week after treatmentSponsors and contacts
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Source ClinicalTrials.gov