NCT07074444

Treatment of Clonorchiasis in Guangxi With Albendazole, Tribendimidine, and Praziquantel

Albendazole, Tribendimidine, and Praziquantel for Clonorchiasis in Guangxi: A Randomized Controlled Trial Comparing Efficacy and Safety

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 318 (estimated)
• Sponsor: First Affiliated Hospital of Guangxi Medical University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to evaluate and compare the efficacy and safety of three commonly used antiparasitic drugs-albendazole, tribendimidine, and praziquantel-for the treatment of clonorchiasis, a liver fluke infection acquired by consuming raw or undercooked freshwater fish. This study aims to answer the following primary questions: How effective is each drug in achieving parasitological cure, as measured by clearance of Clonorchis sinensis eggs in stool? What types and frequencies of adverse events are associated with each treatment? Participants in this randomized, open-label trial will: Be randomly assigned to receive one of the three study drugs according to a predefined dosing regimen. Provide stool samples before treatment and at follow-up to assess for Clonorchis sinensis eggs. Undergo a second round of the same treatment regimen and repeated stool examination if eggs are still detected after the first course. Attend follow-up visits, which include symptom assessment, blood tests (hematology and liver function), and abdominal ultrasonography focusing on hepatobiliary changes. Report any side effects, discomfort, or adverse reactions experienced during or after treatment. The findings from this study will help inform optimal therapeutic strategies for clonorchiasis in outpatient clinical settings.

Conditions

• Clonorchiasis

Interventions

Type	Name	Description
DRUG	Albendazole	Participants receive albendazole tablets orally at a total daily dose of 10 mg/kg for 7 consecutive days. The daily dose will be administered in two divided doses. If the calculated dose results in a non-integer number of tablets, the dose will be adjusted to the nearest whole tablet as per the physician's recommendation.
DRUG	Tribendimidine	Patients receive tribendimidine enteric-coated tablets orally at 0.4 g once daily (QD) for 3 consecutive days.
DRUG	praziquantel	Participants receive praziquantel tablets orally at 25 mg/kg per dose, three times daily (TID) for 2 consecutive days. If the calculated dose results in a non-integer number of tablets, the dose will be adjusted to the nearest whole tablet as per the physician's recommendation.

Timeline

• Start date: 2025-07-22
• Primary completion: 2026-11-30
• Completion: 2026-12-31
• First posted: 2025-07-20
• Last updated: 2025-08-17

Locations

2 sites across 1 country: China