Trichomonas Vaginitis
Conditions
Keywords
Refractory Trichomonas Vaginitis, Tinidazole
Brief summary
We compare two oral tinidazole regimens for refractory trichomonas vaginitis.
Detailed description
Refractory trichomonas vaginitis has become a clinical problem, which has a direct impact on the health and life of patients. Refractory trichomonas vaginitis is mainly caused by drug resistance of trichomonas. Drug resistant trichomonas has appeared China. Increasing the dosage of anti trichomonal drugs is the main treatment method at present. The aim of this study was to evaluate the efficacy and safety of two oral tinidazole regimens for refractory trichomonas vaginitis.
Interventions
DRUGTinidazole 56
Tinidazole , 2g， twice daily for 14 days. At the same time, metronidazole, 400 mg, once a day, vaginal administration, 14 days.
DRUGTinidazole 42
Tinidazole , 1g, three times daily for 14 days. At the same time, metronidazole, 400 mg, once a day, vaginal administration, 14 days.
Sponsors
Shangrong Fan
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
For patients who failed to conventional treatment (recommended by the guidelines including tinidazole, 2g once daily for 5-7 days), the following regimens were selected: Tinidazole , 2g twice daily for 14 days. At the same time, metronidazole, 400 mg, daily, vaginal administration for 14 days. Tinidazole , 1g three times daily for 14 days. At the same time, metronidazole, 400 mg, daily, vaginal administration for 14 days.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* Women be at least 18 years of age * Failure of conventional treatment (recommended by guidelines including tinidazole, 2g once daily for 5-7 days)
Exclusion criteria
* Allergy to metronidazole or tinidazol * Pregnant or nursing * HIV or other chronic disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cure rate of refractory trichomoniasis | 24 weeks | Evaluate the efficacy of oral tinidazole tablets in the treatment of refractory trichomoniasis.Diagnosis of vaginal trichomoniasis is performed by microscopy of vaginal secretions. Cure or failure was based on positive or negative T. vaginalis on vaginal secretions by microscopy examination. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety of tinidazole tablets | 24 weeks | Number of participants with treatment-related adverse events as assessed by CTCAE v4.0. Test of blood routine,liver function, kidney function ,and urine routine will be done before treatment.The same test will be were reviewed within 1 week after treatment. |
Countries
China
Contacts
Primary ContactYiheng Liang, M.D.
Backup ContactPing Liu, M.D.
Outcome results
None listed