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NCT Number: NCT04574089

Treatment for Aerobic Vaginitis by Using Bofukang Vaginal Suppository

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.

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Key information

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Peking University Shenzhen Hosptal

Shenzhen, Guangdong, 518036, China

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Experimental: Baofukang Suppository 7 days

Drug

Experimental: Baofukang Suppository 7 days

Other names: Baofukang Suppository 7 days

Experimental: Baofukang Suppository 14 days

Drug

Experimental: Baofukang Suppository 14 days

Other names: Baofukang Suppository 14 days

Primary outcomes

  1. Cure rate

    Time frame: First week after treatment

    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.

  2. Cure rate

    Time frame: First month after the treatment

    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.

Secondary outcomes

  1. Side affect

    Time frame: First week after treatment

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

Study contacts

Contact information is provided by the study sponsor or research team.

Ping Liu, M.D.

CONTACT

[email protected]

86755-83923333 ext. 5505

Yiheng Liang, M.D.

CONTACT

[email protected]

86755-83923333 ext. 5518

Sponsors and collaborators

Lead sponsor

Peking University Shenzhen Hospital

Other

Registry information

Official study title

Medical Ethics Committee of Peking University Shenzhen Hospital

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Oct 5, 2020
Registry last updated
Jun 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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