Trichomonas Vaginitis Clinical Trial
Official title:
Oral Tinidazole Treatment of Refractory Trichomonas Vaginitis
We compare two oral tinidazole regimens for refractory trichomonas vaginitis.
| Status | Not yet recruiting |
| Enrollment | 20 |
| Est. completion date | December 30, 2025 |
| Est. primary completion date | December 30, 2025 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years to 55 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| China | Beijing Obstetrics and Gynecology Hospital,Capital Medical University | Peking | |
| China | Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua University | Peking | |
| China | Peking University First Hospital | Peking | |
| China | Peking University Shenzhen Hospital | Shenzhen | Guangdong |
| Lead Sponsor | Collaborator |
|---|---|
| Shangrong Fan |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Cure rate of refractory trichomoniasis | 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. | 24 weeks | |
| Secondary | Safety of tinidazole tablets | 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. | 24 weeks |
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