Actively Recruiting

Phase 4
Age: 18Years +
All Genders
NCT07074444

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

Led by First Affiliated Hospital of Guangxi Medical University · Updated on 2025-08-17

318

Participants Needed

2

Research Sites

75 weeks

Total Duration

On this page

Sponsors

F

First Affiliated Hospital of Guangxi Medical University

Lead Sponsor

P

People's Hospital of Guangxi Zhuang Autonomous Region

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 years or older
  • Confirmed Clonorchis sinensis infection by detecting eggs or adult worms in stool or bile drainage fluid
  • Willing and able to provide written informed consent and follow study procedures
Not Eligible

You will not qualify if you...

  • Known allergy to albendazole, praziquantel, or tribendimidine
  • Supraventricular tachycardia or atrial fibrillation confirmed by ECG
  • Diagnosed neurocysticercosis or ocular cysticercosis
  • Presence of gallbladder stones or bile duct obstruction confirmed by ultrasound
  • Severe liver, kidney, or heart dysfunction or active peptic ulcer disease
  • Pregnant or breastfeeding individuals or those unwilling to use effective contraception during and 3 months after the study
  • Expected inability to complete the study due to relocation, withdrawal, or other adherence issues

AI-Screening

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Trial Site Locations

Total: 2 locations

1

People's Hospital of Guangxi Zhuang Autonomous Region

Nanning, Guangxi, China, 530021

Not Yet Recruiting

2

The First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, China, 530021

Actively Recruiting

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Research Team

H

Hongliang Zhang

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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