VVC
Conditions
Interventions
control group:Fluconazole + Kushen gel placebo
treatment group:Fluconazole + Kushen gel
Sponsors
Beijing Obstetrics and Gynecology Hospital, Capital Medical University
Eligibility
Sex/Gender
Female
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1. Women aged 18-50 years (including the threshold) with a sexual life history; 2. The results of vaginal secretion test indicate that candida (mycelium/pseudomycelium/budding) is positive; 3. Contraception during the trial, and the contraceptive method is barrier contraception; 4. Agree to refrain from using any other vaginal products (contraceptive creams, foams, sponges, lubricants, douches, etc.) throughout the trial period; 5. Patients with follow-up conditions, good compliance and signed informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients during pregnancy, lactation, pregnancy preparation and menopause; 2. Patients with recurrent VVC (RVVC) who had four or more episodes of symptomatic VVC within one year; 3. Combined with cervical diseases, such as cervical inflammation, cervical precancer, cervical cancer, confirmed high-risk human papillomavirus (HPV) infection or cervical intraepithelial neoplasia of grade 2 or 3 (CIN2, CIN3); 4. Combine other diseases that doctors believe can cause vulvovaginal symptoms; 5. Patients with autoimmune diseases or poorly controlled diabetes; 6. Those who have used antifungal drugs in the past 2 weeks or have had a history of vulvovaginal medicine and irrigation; 7. Patients identified by the investigators as unsuitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Itch disappearance time; | — |
Secondary
| Measure | Time frame |
|---|---|
| cure rate;Symptom resolution time;VVC score;Proportion of subjects whose symptoms disappeared;Proportion of subjects whose symptoms improved;Candida clearance;recurrence rate;Vaginal microecological indicators; | — |
Countries
China
Contacts
Public ContactLiu Zhaohui
Beijing Obstetrics and Gynecology Hospital, Capital Medical University
Outcome results
None listed