Treatment for Aerobic Vaginitis by Using Bofukang Vaginal Suppository
Medical Ethics Committee of Peking University Shenzhen Hospital
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started May 2020
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 20, 2020
CompletedStudy Start
First participant enrolled
May 1, 2020
CompletedFirst Posted
Study publicly available on registry
October 5, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 30, 2026
June 12, 2025
June 1, 2025
6.7 years
February 20, 2020
June 9, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (1)
Side affect
First week after treatment
Study Arms (2)
Baofukang Suppository 7 days
EXPERIMENTALBaofukang Suppository (1.74g), for vaginal external use, 2 capsules per night for 7 days
Baofukang Suppository 14 days
EXPERIMENTALBaofukang Suppository (1.74g), for vaginal external use, 2 capsules per night for 14days
Interventions
Experimental: Baofukang Suppository 7 days
Experimental: Baofukang Suppository 14 days
Eligibility Criteria
You may qualify if:
- Aerobic vaginitis diagnosed based on present ：
- Vaginal dischareg ;
- pH \> 4.5;
- Donders score≥3;
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Peking University Shenzhen Hosptal
Shenzhen, Guangdong, 518036, China
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shangrong Fan, M.D.
Dept of Obstetrics and Gynecology,Peking University Shenzhen Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 20, 2020
First Posted
October 5, 2020
Study Start
May 1, 2020
Primary Completion (Estimated)
December 30, 2026
Study Completion (Estimated)
December 30, 2026
Last Updated
June 12, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will not share