Treatment for Aerobic Vaginitis by Using Bofukang Vaginal Suppository

Peking University

Status and phase: Enrolling; Phase 3

Conditions: Vaginitis

Treatments: Drug: Experimental: Baofukang Suppository 7 days; Drug: Experimental: Baofukang Suppository 14 days

Study type: Interventional

Funder types: Other

Identifiers

NCT04574089

PUShenzhenH

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 50 estimated patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Aerobic vaginitis diagnosed based on present ：

1. Vaginal dischareg ;
2. pH > 4.5;
3. Donders score≥3;

Exclusion criteria

1. Patients with other vaginitis, cervical erosion, or suspected gonorrhea, herpes simplex virus infection and other vulvar diseases;
2. Patients received systemic or vaginal antifungal or antibiotic treatment within two weeks before admission.
3. Pregnancy, lactation and intentional pregnancy;
4. Women with liver and kidney dysfunction, low immune function, diabetes, psychosis or other serious diseases;
5. Allergic constitution and patients allergic to drug ingredients in this study;
6. Those with poor compliance.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Baofukang Suppository 7 days

Experimental group

Description:

Baofukang Suppository (1.74g), for vaginal external use, 2 capsules per night for 7 days

Treatment:

Drug: Experimental: Baofukang Suppository 7 days

Baofukang Suppository 14 days

Experimental group

Description:

Baofukang Suppository (1.74g), for vaginal external use, 2 capsules per night for 14days

Treatment:

Drug: Experimental: Baofukang Suppository 14 days