Tribendimidine in the treatment of liver fluke infection in China
- Conditions
- iver fluke infections (Clonorchis sinesis)Infections and InfestationsClonorchiasis
- Registration Number
- ISRCTN80829842
- Lead Sponsor
- Medical Research Council (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 75
1. Patients (adults aged =18 years) infected with C. sinensis, as assessed by the presence of eggs in the stool
2. Signed written informed consent
3. Able and willing to be examined by a study physician at the beginning of the study and at the end-of study follow-up survey (3 - 4 weeks post-treatment)
4. Able and willing to provide multiple stool samples at the beginning and end of study
5. Absence of major systemic illnesses, psychiatric and neurological disorders as assessed by the medical doctor, upon initial clinical assessment
6. No known or reported hypersensitivity to tribendimidine or praziquantel
7. No known or reported history of chronical illness as cancer, diabetes, chronic heart, liver or renal disease
8. For females, not pregnant in the first trimester, as assessed by a female nurse (interview and pregnancy test if need be), upon initial clinical assessment
1. For females, pregnancy in first trimester
2. Presence of any abnormal medical condition, judged by the study physician
3. History of acute or severe chronic disease
4. Known or reported hypersensitivity to tribendimidine or praziquantel
5. Known or reported psychiatric or neurological disorders
6. Use of any anthelmintic within the past month
7. Attending other clinical trials during the study
8. Absence of signed written informed consent sheet
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cure rates and egg reduction rates three weeks after treatment: <br>For diagnosis three stool samples will be collected before and after treatment. From each stool sample three Kato-Katz thick smears will be examined. Additionally 1g of stool will be preserved for later diagnosis with the ether concentration method.
- Secondary Outcome Measures
Name Time Method Adverse events due to specific treatment: <br>Participants will be monitored 3 hours after treatment. 24 hours after each day of treatment they will be asked with a standard questionnaire for adverse events.