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A randomized, open, positive controlled clinical study to evaluate the efficacy and safety of Baofukang Shuan in the treatment of bacterial vaginosis (BV)

A randomized, open, positive controlled clinical study to evaluate the efficacy and safety of Baofukang Shuan in the treatment of bacterial vaginosis (BV)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300069414
Enrollment
Unknown
Registered
2023-03-15
Start date
2023-03-16
Completion date
Unknown
Last updated
2023-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bacterial vaginosis

Interventions

test group :Baofukangshuan
Control group:Metronidazole vaginal gel

Sponsors

Hainan Women's and Children's Medical Center
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Women aged over 18 years are sexually active; 2. Bacterial vaginosis (BV) was diagnosed; 3. Informed consent and voluntary participation in this study, and signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Vaginitis caused by other infections (not BV); 2. Pregnant and lactating women; 3. Patients who have used systemic or vaginal antibiotics within the last 14 days; 4. Patients with cardiovascular and cerebrovascular diseases, abnormal liver and kidney function, hematopoietic system and other serious primary diseases, psychiatric patients; 5. Allergic to Baofukang Suppositories or metronidazole or pyrrole drugs; 6. Other situations in which the researcher did not consider participation appropriate.

Design outcomes

Primary

MeasureTime frame
Cure rate of BV after 3 to 5 days of discontinuation.;

Secondary

MeasureTime frame
Cure rate of BV after 28 +/- 3 days of discontinuation;Relapse rate of BV after 28 +/- 3 days of discontinuation;Improvements in vaginal microecology;

Countries

China

Contacts

Public ContactWang Xiaoli

Hainan Women's and Children's Medical Center

sfywxl@163.com+86 898 36373861

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026