Safety and Efficacy of Two Oral Tinidazole Regimens for Refractory Trichomonas Vaginitis

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-55
SponsorShangrong Fan

About this trial

We compare two oral tinidazole regimens for refractory trichomonas vaginitis.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Tinidazole 56

    Drug

    Tinidazole , 2g, twice daily for 14 days. At the same time, metronidazole, 400 mg, once a day, vaginal administration, 14 days.

  • Tinidazole 42

    Drug

    Tinidazole , 1g, three times daily for 14 days. At the same time, metronidazole, 400 mg, once a day, vaginal administration, 14 days.

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Tinidazole 56Experimental treatment 1 intervention
Group B: Tinidazole 42Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
24 weeks

Secondary outcomes

1

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.

Time frame
24 weeks

Other outcomes

Sponsors and contacts

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Shangrong Fan

Lead sponsor

Peking University Shenzhen Hospital

Sponsor institution

This trial is not recruiting at the moment. You can still explore other options: