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A multicenter clinical study on the efficacy of Honghe Fujie lotion in the treatment of aerobic vaginitis combined with bacterial vaginosis

A multicenter clinical study on the efficacy of Honghe Fujie lotion in the treatment of aerobic vaginitis combined with bacterial vaginosis

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200063436
Enrollment
Unknown
Registered
2022-09-06
Start date
2022-09-20
Completion date
Unknown
Last updated
2023-04-17

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

Honghe Fujie lotion :Flush vagina and vulva with Honghe Fujie lotion
Clindamycin cream vaginal application group:Clindamycin cream vaginal application
Honghe Fujie lotion with Clindamycin cream vaginal application group:Flush vagina and vulva with Honghe Fujie lotion with Clindamycin cream vaginal application

Sponsors

Tianjin Medical University General Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 50 Years

Inclusion criteria

Inclusion criteria: 1. Screening AV patients with BV mixed vaginitis, namely AV score >= 3 and Nugent score >= 7; 2. Voluntary subjects with follow-up conditions, good compliance and informed consent; 3. Aged 18-50 years, sexual history, non-menstruation, non-menopause; 4. Patients who have not used any oral drugs to treat the disease in the past 1 month; 5. Patients who have not used any external drugs to treat the disease in the last 2 weeks; 6. Women of childbearing age pregnancy test negative, during the test can adhere to contraception and sex use condoms; 7. Within 14 days from the end of the last menstruation, it can ensure continuous medication for 7 days or more after enrollment

Exclusion criteria

Exclusion criteria: 1. Infected with fungi, viruses or other microorganisms; patients with severe cervical erosion; 2. Patients suffering from other diseases need to be treated with antibiotics, hormones, immunosuppressants and other drugs; 3. HIV positive or abnormal immune function; 4. Diabetic patients with poor blood glucose control; 5. Severe liver and kidney dysfunction; Heart disease, such as congestive heart failure, malignant arrhythmia; 6. Those who plan other operations during the trial period; 7. Pregnant and lactating women, and those who plan to get pregnant within the last 3 months; 8. allergic constitution, or allergic to the test drug; 9. Participants in other clinical trials within the last 1 month; 10. Unconditional following.

Design outcomes

Secondary

MeasureTime frame
Microscopic diagnostic AV and BV scores were evaluated based on clinical efficacy of symptoms and signs;onset time;recurrence rate;

Primary

MeasureTime frame
AV (aerobic vaginitis) and BV (bacterial vaginosis) scores were diagnosed by microscopy;

Countries

China

Contacts

Public ContactXue Fengxia

Tianjin Medical University General Hospital

xuefengxia@tmu.edu.cn+86 15922125459

Outcome results

None listed

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