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A national multicenter prospective clinical study of ursodeoxycholic acid in the treatment of cholesterol gallstones

A national multicenter prospective clinical study of ursodeoxycholic acid in the treatment of cholesterol gallstones

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100053380
Enrollment
Unknown
Registered
2021-11-20
Start date
2021-12-01
Completion date
Unknown
Last updated
2022-09-26

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

Conditions

cholesterol gallstones

Interventions

Experimental group1:15-18mg/(kg.d)ursodeoxycholic acid
Experimental group2:8-11mg/(kg.d) ursodeoxycholic acid

Sponsors

Shanghai Changzheng Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Have signed the informed consent; 2. Aged 18 to 75 years, weight >= 45KG and <= 90KG, gender is not limited; 3. B-ultrasound diagnosis of gallbladder stones (including sediment-like stones), the largest diameter of gallbladder stones is less than or equal to 10mm, X-ray transparent (full light transmission).

Exclusion criteria

Exclusion criteria: 1. Suffered from acute cholecystitis, acute cholangitis, common bile duct stones, bile duct obstruction, acute pancreatitis within three months; 2. Gallbladder atrophy; 3. Gallbladder stones are opaque to X-ray, gallbladder-filled stones; 4. Frequent biliary colic, severe biliary colic, more than 3 times/week; 5. AST or ALT exceeds 2 times the upper limit of normal; 6. Combining other serious diseases affects the test compliance or efficacy evaluation; 7. Pregnant or planning pregnancy, lactating women; 8. Diagnosed or suspected malignant tumor in the past 5 years; 9. Taking other stone-dissolving drugs within 6 months before enrollment; 10. Those who are allergic to bile acids or any component of the study drug; 11. Those who have participated in other drug trials within 3 months; 12. The researcher believes that it is not suitable for the participant.

Design outcomes

Primary

MeasureTime frame
Complete dissolution rate of gallbladder stones;

Secondary

MeasureTime frame
Effectiveness of treatment;Biliary Abdominal Pain Score;Indigestion Symptom Score;

Countries

China

Contacts

Public ContactXie Weifen

Shanghai Changzheng Hospital

weifenxie@medmail.com+86 21 81885348

Outcome results

None listed

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