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Recruiting NCT04574089

Treatment for Aerobic Vaginitis by Using Bofukang Vaginal Suppository

Phase III Interventional Vaginitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Experimental: Baofukang Suppository 7 days, Experimental: Baofukang Suppository 14 days.
Who it may be relevant to
Registry conditions: Vaginitis. Basic parameters: 18 years — 55 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Medical Ethics Committee of Peking University Shenzhen Hospital

Overview

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

  • Drug Experimental: Baofukang Suppository 7 days
    Experimental: Baofukang Suppository 7 days
  • Drug Experimental: Baofukang Suppository 14 days
    Experimental: Baofukang Suppository 14 days

Primary outcome measures

  • Cure rate [Time frame: First week after treatment]
  • Cure rate [Time frame: First month after the treatment]
Secondary outcome measures (1)
  • Side affect [Time frame: First week after treatment]

Eligibility criteria

Inclusion criteria

Aerobic vaginitis diagnosed based on present :

  • Vaginal dischareg ;
  • pH > 4.5;
  • Donders score≥3;

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Peking University Shenzhen Hosptal — Shenzhen

Identifiers

NCT: NCT04574089 · PUShenzhenH

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗