Vulvovaginal candidiasis is a type of female reproductive tract inflammation caused by Candida albicans (also known as Candida albicans). It is mainly characterized by excessive, abnormal and bean-dreg-like leucorrhea, vulvar flushing, itching, burning pain, and even pain during urination and sexual intercourse.
Conditions
Interventions
Study group 2:Topical application of 1% Clotrimazole Vaginal Cream at 50 mg/day
Control group:Oral Fluconazole Capsule 150 mg
Study group 1:Topical application of 1% Clotrimazole Vaginal Cream at 100 mg/day
Sponsors
Peking University Shenzhen Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Patients are female and aged 18 to 65 years; 2. Patients have had >= 4 VVC attacks in the past year (including screening attacks) and are in the VVC attack stage at the time of screening; 3. The total score of the VVC scale before medication is >= 3 points; 4. Subjects of childbearing age take reliable contraceptive measures throughout the study and for 6 months after the last dose; 5. Patients are able to understand and voluntarily sign the written informed consent form (ICF) and agree to be visited in a timely manner as required by the researcher during the trial; 6. Able to accept local or oral medication and swallow tablets intact.
Exclusion criteria
Exclusion criteria: 1. People who are known to be infected by other pathogens (Chlamydia trachomatis, Neisseria gonorrhoeae, trichomoniasis vaginalis), which may interfere with clinical response evaluation in the judgment of the researcher; 2. People with poorly controlled diabetes (glycated hemoglobin >= 8.5% at screening, or fasting blood glucose >= 110 mg/dL (6.1 mmol/L) ; 3. People known to have immune deficiency, other diseases that cause low immunity, or autoimmune diseases; 4. There is a history of reproductive tract malignancy; 5. Patients need to use prohibited drugs in the study within the following time period: (1) Use systemic or vulvovaginal antifungal drugs, including prescription drugs or over-the-counter products, within 7 days before enrollment and during the study. (2) Use other traditional Chinese medicine prescriptions or proprietary Chinese medicines with antifungal or similar mechanisms of action within 7 days before enrollment; (3) Received estrogen replacement therapy or vulvovaginal topical products within 7 days before enrollment; (4) Received systemic corticosteroids or immunosuppressive therapy within 30 days before enrollment; 6. The patient has a known allergic reaction to any ingredient in the study drug formula; 7. The patient is known to be infected with the HIV virus or is undergoing chemotherapy or is a high-risk group of immunodeficiency; 8. The patient has any major disease that the researcher believes will affect the study (such as acute myocardial infarction, stroke, malignant tumor, etc.) within 30 days before screening; 9. The patient has participated in any other clinical trial at least 30 days (or 5.5 half-lives of the study drug) before signing the informed consent form; 10. Those who have a history of uncontrollable abnormal vaginal bleeding within 6 months before screening and at the time of screening; 11. Those who have a history of vaginal, pelvic or cervical related surgeries or various vaginal operations within 1 month before screening, or those who plan to undergo related surgeries or various vaginal operations during the trial; 12. Those with severe liver and kidney dysfunction at the time of screening (alanine aminotransferase >= 2 times the upper limit of normal value or aspartate aminotransferase >= 2 times the upper limit of normal value or creatinine >= 1.5 times the upper limit of normal value), combined with severe mental illness, or other conditions that the researcher judged to be unsuitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effective evaluation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safty evaluation;Laboratory tests: serum biochemistry, blood pregnancy test, etc.; | — |
Countries
China
Contacts
Public ContactFan Shangrong
Peking University Shenzhen Hospital
Outcome results
None listed