About this trial
We compare two oral tinidazole regimens for refractory trichomonas vaginitis.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Women be at least 18 years of age
Failure of conventional treatment (recommended by guidelines including tinidazole, 2g once daily for 5-7 days)
Disqualifiers
Allergy to metronidazole or tinidazol
Pregnant or nursing
HIV or other chronic disease
Trial design
Single group
Treatments tested in this trial
Tinidazole 56
DrugTinidazole , 2g, twice daily for 14 days. At the same time, metronidazole, 400 mg, once a day, vaginal administration, 14 days.
Tinidazole 42
DrugTinidazole , 1g, three times daily for 14 days. At the same time, metronidazole, 400 mg, once a day, vaginal administration, 14 days.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
Sponsors and contacts
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Shangrong Fan
Lead sponsor
Peking University Shenzhen Hospital
Sponsor institution
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