Vaginitis
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Having at least one of the following subjective or clinically examined symptoms: - Pruritus of the vulva or vagina. - Burning, pain of the vulva or vagina, or dyspareunia. - Clinically examined congestion and swelling of the vaginal mucosa. 2. Female aged 18-50 years old, with sexual history, non-pregnant and non-lactating. 3. Having signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating females (positive urine pregnancy test before enrollment). 2. Use of antibiotics, antifungal agents or probiotic preparations in the recent 2 weeks prior to enrollment. 3. Use of vaginal contraceptives, cervical caps or other vaginal preparations (e.g., spermicides) in the recent 2 weeks prior to enrollment. 4. Presence of other vaginal infections, such as trichomonal vaginitis, candidiasis (confirmed by wet mount microscopy or culture), gonorrhea or chlamydial infection. 5. Presence of immunodeficiency disorders (e.g., HIV/AIDS), autoimmune diseases, or long-term use of immunosuppressive agents. 6. Hypersensitivity to lactobacilli or any ingredient in the investigational product. 7. Severe hepatic, renal, cardiovascular diseases or psychiatric disorders. 8. Participation in another clinical trial within 30 days. 9. History of vaginal surgery or pelvic radiotherapy. 10. Subjects considered by the investigator to be ineligible for the clinical trial or unable to complete the study for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Nugent score;Aerobic Vaginitis Score;Lactobacillus percentage;pH value; | — |
Countries
China
Contacts
The First Affiliated Hospital of Anhui University of Science and Technology