ClonorchiasisNCT07074444
Treatment of Clonorchiasis in Guangxi With Albendazole, Tribendimidine, and Praziquantel
A study testing Albendazole, Tribendimidine and praziquantel in people with Clonorchiasis, run by First Affiliated Hospital of Guangxi Medical University at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clonorchiasis
- What is being tested?
- Albendazole, Tribendimidine and praziquantel
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 318 participants
- Where
- 2 sitesChina
- Study dates
- 22 Jul 2025to 28 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged ≥18 years.
- Confirmed diagnosis of Clonorchis sinensis infection based on the latest Expert Consensus on Diagnosis and Treatment of Food-Borne Parasitic Diseases (2023): detection of eggs or adult worms in stool or bile drainage fluid.
- Willing and able to provide written informed consent and comply with study procedures.
Who cannot join
- Known hypersensitivity or allergy to albendazole, praziquantel, or tribendimidine.
- Electrocardiogram (ECG)-confirmed supraventricular tachycardia or atrial fibrillation.
- Clinically or radiologically diagnosed neurocysticercosis (brain or spinal cord) or ocular cysticercosis (eye or orbit).
- Presence of gallbladder stones or biliary tract obstruction as confirmed by abdominal ultrasound.
- Individuals with severe hepatic, renal, or cardiac dysfunction, or with active peptic ulcer disease.
- Pregnant or breastfeeding individuals, or those of reproductive potential (male or female) who are unwilling to use effective contraception during the study period and for 3 months following the last dose of study medication.
- Anticipated loss to follow-up due to relocation, withdrawal of consent, or other factors affecting adherence to the study protocol.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi, 530021
Li Zhang, +86 18577841728, 30173359@qq.com
Li Zhang
- Recruiting
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, 530021
Hongliang Zhang, +86 13737143253, 277749097@qq.com
Hongliang Zhang
About this study
Official title: Albendazole, Tribendimidine, and Praziquantel for Clonorchiasis in Guangxi: A Randomized Controlled Trial Comparing Efficacy and Safety
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:
Read more
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 and blood tests (hematology and liver function).
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
- Being tested
- Albendazole, Tribendimidine, praziquantel
- Keywords
- Clonorchiasis, Albendazole, Praziquantel, Egg clearance rate, tribendimidine
- Medical subject headings
- Clonorchiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlbendazoleDrug
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.
TribendimidineDrug
Patients receive tribendimidine enteric-coated tablets orally at 0.4 g once daily (QD) for 3 consecutive days.
praziquantelDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Praziquantel | Active comparator | Praziquantel tablets: Administer orally at 25 mg/kg per dose, three times daily (TID) for 2 consecutive days. The dose will be adjusted based on the participant's body weight. If the calculated dose results in a non-integer number of tablets, the dose will be adjusted to the nearest whole tablet according to the physician's recommendation. Receives: Drug: praziquantel |
| Albendazole | Experimental | Albendazole tablets: Administer orally at 10 mg/kg/day for 7 consecutive days. The daily dose will be administered in two divided doses. The dose will be adjusted based on the participant's body weight. If the calculated dose results in a non-integer number of tablets, the actual dose may be adjusted to the nearest whole tablet. The specific dose will be adjusted according to the physician's recommendation. Receives: Drug: Albendazole |
| Tribendimidine | Experimental | Tribendimidine enteric-coated tablets: Administer orally at 0.4 g once daily (QD) for 3 consecutive days. Receives: Drug: Tribendimidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Egg Clearance Rate
The primary outcome is the proportion of participants who test negative for Clonorchis sinensis eggs in at least one stool sample collected 4 weeks after treatment.
Measured: From 4 weeks to 4 months after the last dose of treatment
Secondary outcomes (4)
Symptom Improvement Rate
Symptom improvement will be assessed using a standardized symptom questionnaire or physician-recorded clinical evaluation. Typical symptoms associated with clonorchiasis-such as right upper abdominal pain, fatigue, and diarrhea-will be documented at baseline and again at the Week 4 follow-up visit. A symptom is considered improved if its severity score decreases by at least 50% or if it has completely resolved by that follow-up visit.
Measured: Baseline and Week 4 after the last dose of treatment
Adverse Events (AEs)
Adverse events (AEs) will be collected from the initiation of treatment until the first follow-up visit. All events will be graded according to CTCAE version 5.0, and causality will be assessed using a five-level scale (definitely, probably, possibly, possibly not, and definitely not related). Serious adverse events (SAEs) will be documented and reported separately.
Measured: Baseline and Week 4 after the last dose of treatment
Proportion of Abnormal Hematology and Liver Function Results
Venous blood samples will be collected at baseline and follow-up for hematology and liver function tests. An abnormal result is defined as any value exceeding the laboratory reference range or deemed clinically significant by the investigator.
Measured: Baseline and Week 4 after the last dose of treatment
Drug Intolerance Rate
Drug intolerance is defined as the inability to complete the planned treatment regimen due to serious adverse reactions, interruption of medication, or participant refusal. Data will be collected via participant self-report and investigator inquiry at the follow-up visit.
Measured: From first dose to Day 31 (+1 day) after the last dose of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2025
- Study start22 Jul 2025
- Primary completion28 Feb 2027 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ClonorchiasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 318 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Guangxi Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- People's Hospital of Guangxi Zhuang Autonomous Region, Guangxi Zhuang Autonomous Region Center for Disease Prevention and Control
- Responsible party
- Sponsor
- Investigators
- Hongliang Zhang, Principal investigator, First Affiliated Hospital of Guangxi Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07074444
- Sponsor's protocol ID
- 2025-K0110
- Status last verified
- Sep 2026
- First submitted
- 30 Apr 2025
- Last updated
- 1 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication.
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Albendazole, Tribendimidine, and Praziquantel for Clonorchiasis in Guangxi: A Randomized Controlled Trial Comparing Efficacy and Safety
- ClinicalTrials.gov ID
- NCT07074444
- Acronym / sponsor ID
- 2025-K0110
- Conditions
- Clonorchiasis
- Keywords
- Clonorchiasis, Albendazole, Praziquantel, Egg clearance rate, tribendimidine
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 318 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Guangxi Medical UniversityUniversity, hospital or other
- Collaborators
- People's Hospital of Guangxi Zhuang Autonomous Region, Guangxi Zhuang Autonomous Region Center for Disease Prevention and Control
- Study start
- 22 Jul 2025 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 20 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 and blood tests (hematology and liver function).
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Praziquantel | Active comparator | Drug: praziquantelPraziquantel tablets: Administer orally at 25 mg/kg per dose, three times daily (TID) for 2 consecutive days. The dose will be adjusted based on the participant's body weight. If the calculated dose results in a non-integer number of tablets, the dose will be adjusted to the nearest whole tablet according to the physician's recommendation. |
| Albendazole | Experimental | Drug: AlbendazoleAlbendazole tablets: Administer orally at 10 mg/kg/day for 7 consecutive days. The daily dose will be administered in two divided doses. The dose will be adjusted based on the participant's body weight. If the calculated dose results in a non-integer number of tablets, the actual dose may be adjusted to the nearest whole tablet. The specific dose will be adjusted according to the physician's recommendation. |
| Tribendimidine | Experimental | Drug: TribendimidineTribendimidine enteric-coated tablets: Administer orally at 0.4 g once daily (QD) for 3 consecutive days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults aged ≥18 years.
- Confirmed diagnosis of Clonorchis sinensis infection based on the latest Expert Consensus on Diagnosis and Treatment of Food-Borne Parasitic Diseases (2023): detection of eggs or adult worms in stool or bile drainage fluid.
- Willing and able to provide written informed consent and comply with study procedures.
Key exclusion criteria (7 listed)
- Known hypersensitivity or allergy to albendazole, praziquantel, or tribendimidine.
- Electrocardiogram (ECG)-confirmed supraventricular tachycardia or atrial fibrillation.
- Clinically or radiologically diagnosed neurocysticercosis (brain or spinal cord) or ocular cysticercosis (eye or orbit).
- Presence of gallbladder stones or biliary tract obstruction as confirmed by abdominal ultrasound.
- Individuals with severe hepatic, renal, or cardiac dysfunction, or with active peptic ulcer disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AlbendazoleParticipants 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 | Albendazole |
| TribendimidinePatients receive tribendimidine enteric-coated tablets orally at 0.4 g once daily (QD) for 3 consecutive days. | Drug | Tribendimidine |
| praziquantelParticipants 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. | Drug | Praziquantel |
Primary outcome
Egg Clearance Rate
Time frame: From 4 weeks to 4 months after the last dose of treatment
The primary outcome is the proportion of participants who test negative for Clonorchis sinensis eggs in at least one stool sample collected 4 weeks after treatment.
4 secondary outcomes
Symptom Improvement Rate
Time frame: Baseline and Week 4 after the last dose of treatment
Adverse Events (AEs)
Time frame: Baseline and Week 4 after the last dose of treatment
Proportion of Abnormal Hematology and Liver Function Results
Time frame: Baseline and Week 4 after the last dose of treatment
Drug Intolerance Rate
Time frame: From first dose to Day 31 (+1 day) after the last dose of treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hongliang Zhang principal investigator
First Affiliated Hospital of Guangxi Medical University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Albendazole, Tribendimidine and praziquantel in people with Clonorchiasis, run by First Affiliated Hospital of Guangxi Medical University at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hongliang Zhang (+86 13737143253, 277749097@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Egg Clearance Rate (time frame: From 4 weeks to 4 months after the last dose of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.