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A randomized, multicenter, blank controlled trial for the efficacy and safety of Tauroursodeoxycholic acid for dissolution of cholesterol stones in gallbladder

A randomized, multicenter, blank controlled trial for the efficacy and safety of Tauroursodeoxycholic acid for dissolution of cholesterol stones in gallbladder

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900020504
Enrollment
Unknown
Registered
2019-01-03
Start date
2017-04-17
Completion date
Unknown
Last updated
2019-01-14

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

Conditions

gallstone disease

Interventions

Experimental group:TUDCA at a dose of 250mg, 3 times daily for 48 weeks
Control:No Intervention

Sponsors

Wuhan Union Hospital Affiliated with Tongji Medical College, Huazhong University of Science and Technology
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1) aged 18 to 70 years, male and female; 2) the diagnosis of B ultrasound was confirmed, the CT value was less than 150 HU, and there was no calcification in the core or periphery of the stone; 3) the maximum diameter of stone <10 mm, be relaxed properly for those who insisted on attending the clinical trial; 4) the patient was examined for stones, asymptomatic or only mild upper abdominal fullness after meals, hiccup; 5) informed consent was signed.

Exclusion criteria

Exclusion criteria: 1) Ultrasound B showed intrahepatic and extrahepatic bile duct dilatation; 2) Ultrasound B showed cholecystolithiasis combine with intrahepatic and extrahepatic bile duct calculus; 3) CT > 150 HU, core or peripheral calcification; 4) Severe heart, brain, lung, liver, kidney disease, and severe hypertension; 5) Severe endocrine, blood and neuropsychiatric disorders; 6) Pregnant or lactating women with recent fertility plans; 7) Allergic to study drugs and Persons with hypersensitivity; 8) Other circumstances that the researchers consider unsuitable for participation in this study.

Design outcomes

Primary

MeasureTime frame
Prominent rate and effective rate after 24 weeks treatment for gallstone disolution;

Secondary

MeasureTime frame
Prominent rate and effective rate after 48 weeks treatment for gallstone disolution, and Serum biochemical parameters change;

Countries

China

Contacts

Public ContactXiao-Hua Hou

Digestive Medicine Department, Wuhan Union Hospital Affiliated with Tongji Medical College, Huazhong University of Science and Technology

houxh@hust.edu.cn+86 13035143646

Outcome results

None listed

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