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

NCT ID: NCT05383521

Last Updated: 2024-06-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-01

Study Completion Date

2025-12-30

Brief Summary

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We compare two oral tinidazole regimens for refractory trichomonas vaginitis.

Detailed Description

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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.

Conditions

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Trichomonas Vaginitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Tinidazole 56

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

Group Type EXPERIMENTAL

Tinidazole 42

Intervention Type DRUG

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

Tinidazole 42

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

Group Type EXPERIMENTAL

Tinidazole 56

Intervention Type DRUG

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

Interventions

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Tinidazole 56

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

Intervention Type DRUG

Tinidazole 42

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

Intervention Type DRUG

Other Intervention Names

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Tinidazole M56 Tinidazole M42

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Shangrong Fan

OTHER

Sponsor Role lead

Responsible Party

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Shangrong Fan

Profesor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Shangrong Fan Fan, M.D.

Role: PRINCIPAL_INVESTIGATOR

Peking University Shenzhen Hospital

Locations

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Peking University Shenzhen Hospital

Shenzhen, Guangdong, China

Site Status

Beijing Obstetrics and Gynecology Hospital,Capital Medical University

Beijing, , China

Site Status

Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua University

Beijing, , China

Site Status

Peking University First Hospital

Beijing, , China

Site Status

Countries

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China

Central Contacts

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Yiheng Liang, M.D.

Role: CONTACT

86-755-83923333 ext. 5518

Ping Liu, M.D.

Role: CONTACT

86-755-83923333 ext. 5505

Facility Contacts

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Yiheng liang, M.D.

Role: primary

86-755-83923333 ext. 5518

Ping liu, M.D.

Role: backup

86-755-83923333 ext. 5505

Zhaohui Liu, M.D.

Role: primary

Qinping Liao, M.D.

Role: primary

Dai Zhang, M.D.

Role: primary

Other Identifiers

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2020PUSZH001

Identifier Type: -

Identifier Source: org_study_id

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