Actively Recruiting

Phase 3
Age: 18Years - 55Years
FEMALE
ID04574089

Treatment for Aerobic Vaginitis Using Baofukang Vaginal Suppository Comparing 7-Day and 14-Day Regimens

Led by Peking University Shenzhen Hospital · Updated on 2025-06-12

50

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to evaluate the treatment of aerobic vaginitis using Baofukang Suppository in two different durations. The study compares the effects of a 7-day treatment group versus a 14-day treatment group to assess both efficacy and safety. Participants are female and diagnosed with aerobic vaginitis based on specific clinical signs including vaginal discharge, elevated pH, and Donders score. Participants receive Baofukang Suppository vaginally at a dose of 1.74 grams, with two capsules administered each night. One group uses the suppository for 7 days, while the other group applies it for 14 days. Both groups are monitored after treatment at intervals of 7 to 14 days and again at 35 to 42 days to evaluate outcomes. During the study, participants will undergo assessments to determine the cure rate at one week and one month after treatment. Safety is also monitored by recording any side effects during the first week following treatment. The study involves random assignment to one of the two treatment groups, and participation includes follow-up visits for outcome evaluations. The total participant age range is from 18 to 55 years.

CONDITIONS

Brief Title

Treatment for Aerobic Vaginitis by Using Bofukang Vaginal Suppository

Who Can Participate

Age: 18Years - 55Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female participants aged 18 to 55 years
  • Diagnosed with aerobic vaginitis based on vaginal discharge, pH greater than 4.5, and Donders score of 3 or higher
  • Able to comply with study procedures and follow-up visits
Not Eligible

You will not qualify if you...

  • Having other types of vaginitis, cervical erosion, suspected gonorrhea, herpes simplex virus infection, or other vulvar diseases
  • Received systemic or vaginal antifungal or antibiotic treatment within two weeks before enrollment
  • Pregnant, breastfeeding, or planning pregnancy
  • Women with liver or kidney dysfunction, low immune function, diabetes, psychosis, or other serious diseases
  • Allergic to any ingredients in the study drug
  • Poor compliance or inability to follow study requirements

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 7 to 14 days

Participants receive Baofukang Suppository vaginal suppositories either for 7 days or 14 days depending on their assigned group.

Daily self-administration for 7 or 14 days

Follow-up

Duration - Up to 6 weeks after treatment

Participants are evaluated for efficacy and safety 7 to 14 days and again 35 to 42 days after completing treatment.

2 visits (in-person)

Trial Site Locations

Total: 1 location

1

Peking University Shenzhen Hosptal

Shenzhen, Guangdong, China, 518036

Actively Recruiting

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Research Team

P

Ping Liu, M.D.

Y

Yiheng Liang, M.D.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Frequently Asked Questions

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