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Efficacy of albendazole in treatment of Clonorchis sinensis infection

Comparison on the efficacy of praziquantel and albendazole in treatment of Clonorchis sinensis infection

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN46268871
Enrollment
100
Registered
2025-02-27
Start date
2025-03-20
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Clonorchis sinensis infection Infections and Infestations

Interventions

Light infection (Eggs per gram of feces <1 000): Group 1: albendazole with a dose of 400 mg, twice a day for 4 days Group 2: praziquantel (25 mg/kg 3 times a day for 1 day) Moderate and heavy infecti

Sponsors

National Institute of Parasitic Diseases, Chinese Center for Disease Control and Prevention (Chinese Center For Tropical Disease Research)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Patients (18-70 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 albendazole 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, as assessed by a female nurse (interview and pregnancy test if need be), upon initial clinical assessment

Exclusion criteria

Exclusion criteria: 1. For females, pregnancy 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 albendazole or praziquantel 5. Known or reported psychiatric or neurological disorders 6. Use of any anthelminthic within the past month 7. Attending other clinical trials during the study 8. Absence of signed written informed consent sheet

Design outcomes

Primary

MeasureTime frame
Cure rates and egg reduction rates three weeks after treatment: For diagnosis two stool samples will be collected before and after treatment. From each stool sample three Kato-Katz thick smears will be examined.

Secondary

MeasureTime frame
Adverse events due to specific treatment: Participants will be monitored 3 hours and 24 hours after treatment with a standard questionnaire for adverse events.

Countries

China

Contacts

Public ContactMen-Bao Qian
qianmb@nipd.chinacdc.cn+86-21-64739075

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Aug 10, 2026