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Efficacy and safety of praziquantel, tribendimidine and mebendazole in patients infected with Clonorchis sinensis

Efficacy and safety of praziquantel, tribendimidine and mebendazole in patients infected with Clonorchis sinensis: a single-centre, open-label, randomised controlled study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN55086560
Enrollment
120
Registered
2011-05-19
Start date
2012-06-25
Completion date
Unknown
Last updated
2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Clonorchiasis Infections and Infestations Clonorchiasis

Interventions

Current interventions as of 14/08/2012: The intervention consists of four treatments, all the medicine is administered orally to each person 1. Multiple-dose praziquantel serves as control, and the t

Sponsors

The National Institute of Parasitic Diseases (China)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Current inclusion criteria as of 14/08/2012: Eligible patients are residents of Hunan province aged 15 to 65 years who have Clonorchis sinensis infections, both sexes. Previous inclusion criteria until 14/08/2012: Eligible patients are residents of Guangdong province aged 2 years and above who had Clonorchis sinensis infections, both sexes

Exclusion criteria

Exclusion criteria: 1. Pregnant or lactating women 2. Presence of any abnormal medical condition, such as heart disease, high blood pressure, severe malnutrition, severe liver and kidney disease, psychiatric and neurologic disorders 3. Use of praziquantel , tribendimidine, albendazole and mebendazole or any anthelminthic treatment within the past month 4. Enrolled in any other clinical investigation during the study

Design outcomes

Primary

MeasureTime frame
1. Egg reduction rate (ERR) and cure rate (CR), measured using the Kato-Katz stool examination method 2. Adverse reactions, measured using a standardised questionnaire. The intensity of adverse events was graded as mild, moderate, severe and serious Assessed at 4 weeks after treatment

Secondary

MeasureTime frame
All the participants who are to receive the tribendimidine treatment will accept checks of blood, urine, electrocardiogram, liver function and kidney function before and after the treatment. The abnormal indexes will be supervised and recorded.

Countries

China

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 7, 2026