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Treatment for Aerobic Vaginitis by Using Bofukang Vaginal Suppository

Medical Ethics Committee of Peking University Shenzhen Hospital

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04574089
Enrollment
50
Registered
2020-10-05
Start date
2020-05-01
Completion date
2026-12-30
Last updated
2025-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vaginitis

Keywords

Aerobic vaginitis, Treatment

Brief summary

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

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.

Interventions

DRUGExperimental: Baofukang Suppository 7 days

Experimental: Baofukang Suppository 7 days

DRUGExperimental: Baofukang Suppository 14 days

Experimental: Baofukang Suppository 14 days

Sponsors

Peking University Shenzhen Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Cure rateFirst week after treatmentA 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.

Secondary

MeasureTime frameDescription
Side affectFirst week after treatmentNumber of Participants Experiencing AEs Following the First Dose of the Study Product

Countries

China

Contacts

Primary ContactPing Liu, M.D.
253783006@qq.com86755-83923333
Backup ContactYiheng Liang, M.D.
13510331823@163.com86755-83923333

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026