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Study on the therapeutic effect of Sophora flavescens alkaloid gels in the treatment of aerobic vaginitis combined with bacterial vaginosis

Study on the therapeutic effect of Sophora flavescens alkaloid gels in the treatment of aerobic vaginitis combined with bacterial vaginosis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IOR-17012581
Enrollment
Unknown
Registered
2017-09-05
Start date
2017-10-01
Completion date
Unknown
Last updated
2017-09-11

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

Conditions

aerobic vaginitis combined with bacterial vaginosis

Interventions

Sophora flavescens alkaloid gels treatment group:Sophora flavescens alkaloid gelsVaginal placement
Metronidazole treatment group:Metronidazole oral
Sophora flavescens alkaloid gels treatment group combine Metronidazole treatment group:Sophora flavescens alkaloid gels treatment group combine Metronidazole treatment

Sponsors

Tianjin Medical University General Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Patients with AV combined with BV confirmed by clinical and laboratory pathogenic examination before the test; 2. With follow-up conditions, good compliance and signed informed consent of volunteers; 3. 18-50 years of age with sexual life history, menstrual period; 4. Patients who were not treated with any oral medication in the last one month; 5. Patients who were not treated with any external drugs in the last two weeks; 6. The pregnancy test was negative in women of childbearing age, during the test can adhere to contraception and condom use in life.

Exclusion criteria

Exclusion criteria: 1. Those with fungal, viral or other microbial infections; severe cervical erosion; 2. Other diseases need to be treated with antibiotics, hormones, immunosuppressive drugs and other drugs; 3. HIV positive or abnormal immune function; 4. Patients with poorly controlled diabetes; 5. Severe liver and kidney dysfunction; combined with heart disease such as congestive heart failure, malignant arrhythmia, etc.; 6. During the test the other operation plan; 7. Pregnant and lactating women, and planned pregnancy within 3 months; 8. Allergic, or allergic to this test drug; 9. Other clinical trials in last one month; 10. Unconditional follow-up.

Design outcomes

Primary

MeasureTime frame
AV score was evaluated by wet film microscopy;Nufent score was evaluated by dry slice microscopy;Evaluation of clinical efficacy based on symptoms and signs;Onset time;Recurrence rate;

Countries

China

Contacts

Public ContactFengxia Xue

Tianjin Medical University General Hospital

fengxiaxue1962@163.com+86 15922125459

Outcome results

None listed

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