Treatment for Aerobic Vaginitis by Using Bofukang Vaginal Suppository

Medical Ethics Committee of Peking University Shenzhen Hospital

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.

Study Overview

• Status: Recruiting
• Conditions: Vaginitis
• Intervention / Treatment: Drug: Experimental: Baofukang Suppository 7 days; Drug: Experimental: Baofukang Suppository 14 days

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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Ping Liu, M.D.; Phone Number: 5505 86755-83923333; Email: 253783006@qq.com
• Study Contact Backup: Name: Yiheng Liang, M.D.; Phone Number: 5518 86755-83923333; Email: 13510331823@163.com

Study Locations

• China
  • Guangdong
    • Shenzhen, Guangdong, China, 518036
      • Recruiting
      • Peking University Shenzhen Hosptal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Aerobic vaginitis diagnosed based on present ：

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

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 7 days; Other Names: 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; Experimental: Baofukang Suppository 14 days; Other Names: Baofukang Suppository 14 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Side affect	Number of Participants Experiencing AEs Following the First Dose of the Study Product	First week after treatment

Collaborators and Investigators

• Sponsor: Peking University Shenzhen Hospital
• Investigators: Principal Investigator: Shangrong Fan, M.D., Dept of Obstetrics and Gynecology,Peking University Shenzhen Hospital

Publications and helpful links

Helpful Links

• AV diagnosis and outcome Measure

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2020
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: February 20, 2020
• First Submitted That Met QC Criteria: September 28, 2020
• First Posted (Actual): October 5, 2020

Study Record Updates

• Last Update Posted (Actual): June 12, 2025
• Last Update Submitted That Met QC Criteria: June 9, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Treatment; Aerobic vaginitis
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases, Female; Vaginal Diseases; Vaginitis
• Other Study ID Numbers: PUShenzhenH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No