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A randomized, multicenter, positive drug controlled clinical trials to compare the 12 consecutive months efficacy and safety of albendazole emulsion and albendazole tablets in the treatment of hepatic cystic echinococcosis.

A randomized, multicenter, positive drug controlled clinical trials to compare the 12 consecutive months efficacy and safety of albendazole emulsion and albendazole tablets in the treatment of hepatic cystic echinococcosis.

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-13003740
Enrollment
Unknown
Registered
2013-10-26
Start date
2013-11-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

echinococcosis

Interventions

Group A:emulsion albendazole
Group B:Albendazole tablets

Sponsors

First Affiliated Hospital of Xinjiang Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
14 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Aged 14-70 years old, M (male) or F (female), no district on ethnic group; 2. Random before meeting the following diagnostic standards: A. Imaging of abdominal B ultrasound or CT confirmed; B. Imaging (B-mode ultrasonography) diagnosed with single cyst (CE1) or multiple cyst (CE2), or internal collapse necrosis (CE3) hydatid cysts, maximum diameter less than 8cm (including 8cm); C. Rapid diagnostic kit can be used as auxiliary diagnostic criteria confirmed hydatid. 3. Patients with hepaitc cystic echinococcosis who want be volunteer and accept consecutive maedical treatment at least 12 months; 4. Unwilling to operation or multiple operation to take medication for the recurrence of hepatic cystic echinococcosis; 5. According to the GCP and local regulations, visiting 1 informed consent was signed and dated.

Exclusion criteria

Exclusion criteria: 1. Cystic echinococcosis necrosis of consolidation or completely calcified (CE4 and CE5) and various types of alveolar echinococcosis; 2. Patients with severe single organ or multiple organ function damage; 3. Pregnant and lactating women; 4. Unwilling to accept drug treatment; 5. Patients with abnormal liver function: ALT or AST or bilirubin is 3 times higher than the upper treshold of the normal value; 6. Patients with renal dysfunction: serum creatinine is 2 times higher than the upper limit of the normal value, or urinary protein positive; 7. Allergic constitution and had the history of drug allergy; 8. Need to accept the treatment of other may have effects on liver and kidney function and bone marrow hematopoietic during test; 9. Any researchers think tips may increase the subjects of danger or interference test result or product instructions; 10. Signed informed consent before 3 months, had alcohol or drug abuse, the researchers estimate will affect the test involved, or the presence of any condition causing compliance to study procedures or study drug decline; 11. In signing the informed consent before 30 days, the test was involved in another test of drug; 12. In the clinical trials, any may endanger patient safety to other clinical conditions (the researchers estimate).

Design outcomes

Primary

MeasureTime frame
general effective rate;

Secondary

MeasureTime frame
cure rate;effective rate;

Countries

China

Contacts

Public ContactWen Hao

First Affiliated Hospital of Xinjiang Medical University

dr.wenhao@163.com+86 13609933113

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026