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RecruitingNCT04574089Updated Jun 12, 2025

Treatment for Aerobic Vaginitis by Using Bofukang Vaginal Suppository

A Phase 3 interventional study of Experimental: Baofukang Suppository 7 days and Experimental: Baofukang Suppository 14 days in Vaginitis, sponsored by Peking University Shenzhen Hospital. Recruiting at 1 site in China. Open to female participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2025-06-12.

Sponsored by Peking University Shenzhen Hospital · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Started May 2020; still recruiting 6 years 6 months later.
Phase
Phase 3
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Vaginitis

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Keywords

  • Aerobic vaginitis
  • Treatment
03

In context

Vaginitis

98 studies on the registry are indexed under Vaginitis; 12 are open to participants now.

This study's planned enrollment of 50 is below the median of 108 across 71 interventional studies indexed under Vaginitis.

Browse Vaginitis studies →

Lead sponsor

Peking University Shenzhen Hospital is the lead sponsor of 17 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Aerobic vaginitis diagnosed based on present :

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

Exclusion criteria

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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    Baofukang Suppository 7 days

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

    Drug: Experimental: Baofukang Suppository 7 days

  • Experimental
    Baofukang Suppository 14 days

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

    Drug: Experimental: Baofukang Suppository 14 days

Interventions

  • DrugExperimental: Baofukang Suppository 7 days

    Experimental: Baofukang Suppository 7 days

    Also known as: Baofukang Suppository 7 days

  • DrugExperimental: Baofukang Suppository 14 days

    Experimental: Baofukang Suppository 14 days

    Also known as: Baofukang Suppository 14 days

06

What researchers measure

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 treatment

  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 folowing references.

    Time frame: First month after the treatment

Secondary outcomes

  1. Side affect

    Number of Participants Experiencing AEs Following the First Dose of the Study Product

    Time frame: First week after treatment

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 12, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04574089
Lead sponsor
Peking University Shenzhen Hospital
Responsible party
Shangrong Fan (Principal Investigator, Peking University Shenzhen Hospital) — Principal investigator
First posted
Oct 5, 2020
Start date
May 1, 2020
Primary completion
Dec 30, 2026 (estimated)
Completion
Dec 30, 2026 (estimated)
Last update
Jun 12, 2025

Study contacts

Ping Liu, M.D.
Contact
253783006@qq.com
86755-83923333 ext. 5505
Yiheng Liang, M.D.
Contact
13510331823@163.com
86755-83923333 ext. 5518
Shangrong Fan, M.D.
principal investigator · Dept of Obstetrics and Gynecology,Peking University Shenzhen Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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