Treatment for Aerobic Vaginitis by Using Bofukang Vaginal Suppository

NCT ID: NCT04574089

Last Updated: 2025-06-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-01

Study Completion Date

2026-12-30

Brief Summary

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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

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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.

Conditions

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Vaginitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Baofukang Suppository 7 days

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

Group Type EXPERIMENTAL

Experimental: Baofukang Suppository 7 days

Intervention Type DRUG

Experimental: Baofukang Suppository 7 days

Baofukang Suppository 14 days

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

Group Type EXPERIMENTAL

Experimental: Baofukang Suppository 14 days

Intervention Type DRUG

Experimental: Baofukang Suppository 14 days

Interventions

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Experimental: Baofukang Suppository 7 days

Experimental: Baofukang Suppository 7 days

Intervention Type DRUG

Experimental: Baofukang Suppository 14 days

Experimental: Baofukang Suppository 14 days

Intervention Type DRUG

Other Intervention Names

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Baofukang Suppository 7 days Baofukang Suppository 14 days

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Peking University Shenzhen Hospital

OTHER

Sponsor Role lead

Responsible Party

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Shangrong Fan

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shangrong Fan, M.D.

Role: PRINCIPAL_INVESTIGATOR

Dept of Obstetrics and Gynecology,Peking University Shenzhen Hospital

Locations

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Peking University Shenzhen Hosptal

Shenzhen, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Ping Liu, M.D.

Role: CONTACT

86755-83923333 ext. 5505

Yiheng Liang, M.D.

Role: CONTACT

86755-83923333 ext. 5518

Related Links

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Other Identifiers

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PUShenzhenH

Identifier Type: -

Identifier Source: org_study_id

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