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A randomized, open, positive drug-parallel-controlled, multicenter clinical study of lactobacillus vaginalis capsules for the treatment of bacterial vaginosis and vulvovaginal pseudomyxomatosis

A randomized, open, positive drug-parallel-controlled, multicenter clinical study of lactobacillus vaginalis capsules for the treatment of bacterial vaginosis and vulvovaginal pseudomyxomatosis

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500108208
Enrollment
Unknown
Registered
2025-08-26
Start date
2023-09-11
Completion date
Unknown
Last updated
2025-09-01

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

Conditions

Patients with bacterial vaginosis (BV) or vulvovaginal candidiasis (VVC)

Interventions

Bacterial Vaginosis:Control Group:Metronidazole: Oral, 400mg twice daily, Days 1-7.
Bacterial Vaginosis:Experimental Group:Lactobacillus Vaginal Capsules: Intravaginal administration, 2 capsules once nightly, Days 1-21. Metronidazole: Oral, 400mg twice daily, Days 1-7.
Vulvovaginal Candidiasis: Control Group:Fluconazole: Oral, 150mg once daily, Days 1 and 4.
Vulvovaginal Candidiasis:Experimental Group:Lactobacillus Vaginal Capsules: Intravaginal administration, 2 capsules once nightly, Days 1-21. Fluconazole: Oral, 150mg once daily, Days 1 and 4.

Sponsors

Obstetrics and Gynecology Hospital Affiliated to Fudan University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-75 years (inclusive); 2. Clinical symptoms and pathogenetic tests meet the diagnostic criteria for bacterial vaginosis (BV) or vulvovaginal candidiasis (VVC); 3. Agree to participate in this clinical study and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Pregnant or breastfeeding women or patients who plan to have children within 3 months; 2. Hypersensitivity to the test drug (including microecological agents); 3. Those who have a combination of other infectious diseases of the genitourinary system (e.g. acute urethritis, acute cystitis, trichomoniasis vaginalis, aerobic vaginitis, etc.); 4. Persons with mental illnesses, psychological disorders that cannot be properly expressed; 5. any other condition that, in the opinion of the investigator, makes participation in this clinical study inappropriate.

Design outcomes

Primary

MeasureTime frame
Microscopic examination of vaginal discharge;

Secondary

MeasureTime frame
Complete Blood Count;Urine routine;Liver Function Tests - LFTs;

Countries

China

Contacts

Public ContactSui Long

Obstetrics and Gynecology Hospital Affiliated to Fudan University

suilong@fudan.edu.cn+86 138 0178 8118

Outcome results

None listed

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