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Treatment for Aerobic Vaginitis by Using Bofukang Vaginal Suppository

Primary Purpose

Vaginitis

Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Experimental: Baofukang Suppository 7 days
Experimental: Baofukang Suppository 14 days
Sponsored by
Peking University Shenzhen Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vaginitis focused on measuring Aerobic vaginitis, Treatment

Eligibility Criteria

18 Years - 55 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Peking University Shenzhen HosptalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Baofukang Suppository 7 days

Baofukang Suppository 14 days

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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

Full Information

First Posted
February 20, 2020
Last Updated
May 4, 2023
Sponsor
Peking University Shenzhen Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04574089
Brief Title
Treatment for Aerobic Vaginitis by Using Bofukang Vaginal Suppository
Official Title
Medical Ethics Committee of Peking University Shenzhen Hospital
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2020 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University Shenzhen Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vaginitis
Keywords
Aerobic vaginitis, Treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Baofukang Suppository 7 days
Arm Type
Experimental
Arm Description
Baofukang Suppository (1.74g), for vaginal external use, 2 capsules per night for 7 days
Arm Title
Baofukang Suppository 14 days
Arm Type
Experimental
Arm Description
Baofukang Suppository (1.74g), for vaginal external use, 2 capsules per night for 14days
Intervention Type
Drug
Intervention Name(s)
Experimental: Baofukang Suppository 7 days
Other Intervention Name(s)
Baofukang Suppository 7 days
Intervention Description
Experimental: Baofukang Suppository 7 days
Intervention Type
Drug
Intervention Name(s)
Experimental: Baofukang Suppository 14 days
Other Intervention Name(s)
Baofukang Suppository 14 days
Intervention Description
Experimental: Baofukang Suppository 14 days
Primary Outcome Measure Information:
Title
Cure rate
Description
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
Title
Cure rate
Description
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 Outcome Measure Information:
Title
Side affect
Description
Number of Participants Experiencing AEs Following the First Dose of the Study Product
Time Frame
First week after treatment

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Women with sexual activity
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ping Liu, M.D.
Phone
86755-83923333
Ext
5505
Email
253783006@qq.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yiheng Liang, M.D.
Phone
86755-83923333
Ext
5518
Email
13510331823@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shangrong Fan, M.D.
Organizational Affiliation
Dept of Obstetrics and Gynecology,Peking University Shenzhen Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking University Shenzhen Hosptal
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518036
Country
China
Individual Site Status
Recruiting

12. IPD Sharing Statement

Links:
URL
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8775230/pdf/diagnostics-12-00185.pdf
Description
AV diagnosis and outcome Measure

Learn more about this trial

Treatment for Aerobic Vaginitis by Using Bofukang Vaginal Suppository

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