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We compare two oral tinidazole regimens for refractory trichomonas vaginitis.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tinidazole 56 | Experimental | Tinidazole , 2g， twice daily for 14 days. At the same time, metronidazole, 400 mg, once a day, vaginal administration, 14 days. |
|
| Tinidazole 42 | Experimental | Tinidazole , 1g, three times daily for 14 days. At the same time, metronidazole, 400 mg, once a day, vaginal administration, 14 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tinidazole 56 | Drug | Tinidazole , 2g， twice daily for 14 days. At the same time, metronidazole, 400 mg, once a day, vaginal administration, 14 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yiheng Liang, M.D. | Contact | 86-755-83923333 | 5518 | 13510331823@163.com |
| Ping Liu, M.D. | Contact | 86-755-83923333 | 5505 | 253783006@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Shangrong Fan Fan, M.D. | Peking University Shenzhen Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Shenzhen Hospital | Shenzhen | Guangdong | 518000 | China |
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| ID | Term |
|---|---|
| D014247 | Trichomonas Vaginitis |
| ID | Term |
|---|---|
| D014245 | Trichomonas Infections |
| D011528 | Protozoan Infections |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
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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.
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| 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. |
|
|
| Beijing Obstetrics and Gynecology Hospital,Capital Medical University | Beijing | China |
|
| Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua University | Beijing | China |
|
| Peking University First Hospital | Beijing | China |
|
| D014627 |
| Vaginitis |
| D014623 | Vaginal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |