Candidal vaginitis
Conditions
Interventions
1:Boric acid vaginal suppository
2:Teconazole 80 mg vaginal suppository
Sponsors
Institute of dermatology and mycosis, second affiliated hospital of naval medical university, Shanghai changzheng hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Be willing and able to provide written informed consent; 2. At least 18 years of age at screening (V0); 3. According to the medical history, targeted physical examination and pelvic examination resulted in good overall health; 4. For participants over 21 years of age, the Papanicolaou test (Pap test) was performed in the past 3 years, the latest result was normal or atypical atypical squamous cell (ASCUS) human papillomavirus (HPV) negative or the Pap smear was collected in V0 *;* according to current pap smear guidelines, pap smears must be performed at V0 for women who meet the following criteria and are unable to provide a normal or an ASCUS HPV negative pap smear performed in the past 3 years: (1) in the past 20 years have had a hysterectomy or (2) have had a hysterectomy and there are 2 levels of cervical intraepithelial neoplasia (CIN2plus) history of note: if in the cervical smear, where V0 is don't need the result before register; 5. By the researchers discretion to decide whether is willing and able to in the procedures for the scope and extent of cooperation; 6. Meet the diagnostic criteria; 7. Aged 18-60 years with sexual life cycle, in non-menstrual period; 8. Patients with serious diseases of liver, kidney and hematopoietic system; 9. No other vaginal infectious diseases, such as trichomonas vaginitis bacterial vaginosis, etc.; 10. Have not used other antifungal drugs in the past two weeks; 11. Have no history of vulvar vaginal irrigation in recent two weeks; 12. Volunteers with follow-up conditions, good compliance and signing informed consent; 13. All subjects agreed to use contraception from the date of signing the informed consent to the 6 weeks after the end of the last medication; 14. Female subjects must meet one of the following conditions: postmenopausal, with at least 1 year of menopause;With fertility ability, the following conditions should be met: negative results of serum/urine pregnancy test before inclusion;Throughout the study period, agreed to adopt a recognized very effective contraceptives [is defined as: ability to stick to and proper use, low failure rate at 1% a year, for example: combined hormone (contain estrogen and progesterone) combining inhibit ovulation progestin contraception and inhibit ovulation intrauterine device (IUD) intrauterine hormone release system (IUS) bilateral tubal ligation vasectomy prohibits sexual behavior.
Exclusion criteria
Exclusion criteria: 1. Diagnosis of another vaginal or vulvar disease may confuse the interpretation of the study product (IP) such as lichen planus erotica, desclastic vaginitis, or contact dermatitis involving vulvar epithelium; 2. Concurrent vulvar candida infection (VVC) that cannot be treated by oral fluconazole; 3. Confirmed by physical examination and/or laboratory examination as the cause of infection of cervicitis (e.g. neisseria gonorrhoeae, chlamydia trachomatis or mycoplasma vaginitis); 4. Successful treatment of mixed stis may require re-screening of women; 5. Positive NAAT test results will be reviewed before registration; 6. Vulvovaginitis caused by other infectious causes such as trichomonas vaginitis or suspected gonorrhea, condyloma acuminatum and other active genital lesions, including sores or vesicles consistent with herpes or warts; 7. Immunosuppressive therapy or systemic antibiotic therapy planned in the course of the study; 8. Allergic reaction to the use of metronidazole, allergy or other contraindicated history or unwilling to take metronidazole orally; 9. With history of allergies to any gel ingredients; 10. Current or untreated cervical intraepithelial neoplasia (CIN) or cervical cancer; 11. Currently pregnant or breastfeeding; 12. With poor compliance; 13. Clinically significant laboratory abnormalities: (1) transaminase was 3 times higher than normal; (2) the WBC < 3.6 x 10^9/L; (3) PLT < 70 x 10^9/L; (4) abnormal ecg with clinical significance; (5) BUN or Cr was higher than normal; 15. With A history of alcohol or other substance abuse, drug use, or problems that may make subjects unreliable for the study; 16. Women with liver and kidney dysfunction, immunosuppressants, blood diseases, diabetes, mental illness or other serious diseases; 17. Those treated with antibiotics within the last two weeks; 18. Patients with gynecological diseases requiring treatment, such as bartolin cyst, abscess, PID; 19. Have been treated for other diseases within the last two weeks; 20. For other reasons considered inappropriate for inclusion by the investigator, any condition or use of any drug that may interfere with the conduct or outcome of the study or place the prospective subjects at higher risk, any other conditions that interfere with the study; 21. The patient is a relative of the investigator or a person who reports directly to the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mycosis cure rate, vaginal swab culture of negative candida??????; | — |
Countries
China
Contacts
Public ContactPan Weihua
Shanghai Changzheng Hospital
Outcome results
None listed