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Treatment for Aerobic Vaginitis by Using Bofukang Vaginal Suppository

Sponsor
Peking University Shenzhen Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04574089
Collaborator
(none)
50
Enrollment
1
Location
2
Arms
32
Anticipated Duration (Months)
1.6
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Experimental: Baofukang Suppository 7 days
  • Drug: Experimental: Baofukang Suppository 14 days
 Phase 3

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 714 days after treatment and 3542 days after treatment.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Medical Ethics Committee of Peking University Shenzhen Hospital
Actual Study Start Date :
May 1, 2020
Anticipated Primary Completion Date :
Dec 30, 2022
Anticipated Study Completion Date :
Dec 30, 2022

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Cure rate [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 [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 Outcome Measures

    1. Side affect [First week after treatment]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Peking University Shenzhen Hosptal Shenzhen Guangdong China 518036

    Sponsors and Collaborators

    • Peking University Shenzhen Hospital

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Shangrong Fan, Principal Investigator, Peking University Shenzhen Hospital
    ClinicalTrials.gov Identifier:
    NCT04574089
    Other Study ID Numbers:
    • PUShenzhenH
    First Posted:
    Oct 5, 2020
    Last Update Posted:
    Mar 7, 2022
    Last Verified:
    Mar 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Shangrong Fan, Principal Investigator, Peking University Shenzhen Hospital
    Aerobic vaginitis
    Treatment
    Additional relevant MeSH terms:
    Vaginitis

    Study Results

    No Results Posted as of Mar 7, 2022