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A randomized, controlled, multicenter clinical study of traditional Chinese medicine for prevention of recurrence of calculi after choledocholithiasis removal

A randomized, controlled, multicenter clinical study of traditional Chinese medicine for prevention of recurrence of calculi after choledocholithiasis removal

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100043439
Enrollment
Unknown
Registered
2021-02-18
Start date
2021-02-18
Completion date
Unknown
Last updated
2022-01-04

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

Conditions

choledocholithiasis

Interventions

Experimental group:Chinese traditional medicine
control group:placebo

Sponsors

The Second Hospital of Shandong University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1) Patients with choledocholithiasis confirmed by enhanced CT or MRCP; 2) Age: 18-90 years old, gender is not limited; 3) No residual stones were confirmed by cholangiography after lithotomy/drainage; 4) In good general condition, Karnofsy score >= 60 points in the week before enrollment; 5) Patients diagnosed with Liver Depression and Qi Stagnation by traditional Chinese medicine or transformed into Liver Depression and Qi Stagnation syndrome after treatment; 6) Patients signed an informed consent to participate in the study and guaranteed follow-up.

Exclusion criteria

Exclusion criteria: 1) Previous (within 5 years) or concurrent malignant tumor; 2) Residual calculus after treatment; 3) Complicated gallstones and/or intrahepatic bile duct stones; 4) Patients with serious heart, lung and kidney diseases, cerebrovascular accidents and severe diabetic complications; 5) Pregnant or lactating patients; Patients with mental disorders; 6) People with allergic constitution or known allergy to the ingredients of this medicine; 7) Participating in other drug clinical trials or receiving other Chinese medicine treatment; 8) A history of severe malnutrition, infectious diseases and alcohol and drug addiction; 9) Irritable bowel syndrome and one-year inflammatory bowel disease; 10) Defective diseases of hearing, vision or movement disorders; 11) Other reasons considered by the investigator to be.

Design outcomes

Primary

MeasureTime frame
Stone recurrence rate;

Countries

China

Contacts

Public ContactYuliang Li

The Second Hospital of Shandong University

lyl.pro@sdu.edu.cn+86 15153169899

Outcome results

None listed

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