Treatment for Aerobic Vaginitis by Using Bofukang Vaginal Suppository

Vaginitis Clinical Trial

Official title:

Medical Ethics Committee of Peking University Shenzhen Hospital

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04574089
• Other study ID #: PUShenzhenH
• Status: Recruiting
• Phase: Phase 3
• Start date: May 1, 2020
• Est. completion date: December 30, 2023

Study information

• Verified date: May 2023
• Source: Peking University Shenzhen Hospital
• Contact: Ping Liu, M.D.
• Phone: 86755-83923333
• Email: 253783006[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 30, 2023
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Vaginitis

Intervention

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

Locations

Country	Name	City	State
China	Peking University Shenzhen Hosptal	Shenzhen	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Shenzhen Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Side affect	Number of Participants Experiencing AEs Following the First Dose of the Study Product	First week after treatment

External Links

•   AV diagnosis and outcome Measure