A Phase 4 interventional study of oral Danshu capsule in Choledocholithiasis and Recurrence, sponsored by First People's Hospital of Hangzhou. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-07-24.
Sponsored by First People's Hospital of Hangzhou · Phase 4, Interventional, and Treatment
[objective] to compare the efficacy of Danshu capsule and ursodeoxycholic acid (UDCA) in preventing recurrence of choledocholithiasis after operation. [methods] one hundred and fifty ERCP patients with choledocholithiasis were randomly divided into two groups: Danshu group (n = 75) and UDCA group (n = 75). The Danshu group took 2 Danshu capsules three times a day, and the UDCA group took 250 mg of Ursofalk twice a day. The clinical efficacy, changes of liver function indexes before and after treatment and stone recurrence were compared between the two groups.
104 studies on the registry are indexed under Choledocholithiasis; 23 are open to participants now.
This study's enrollment of 150 is above the median of 108 across 70 interventional studies indexed under Choledocholithiasis.
Browse Choledocholithiasis studies →First People's Hospital of Hangzhou is the lead sponsor of 70 studies on the registry; 26 are open to participants now.
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exclusion criteria：
The patients in Danshu group were treated with Danshu capsule, 2 tablets per time, 3 times a day (0.45g/ tablets)，The course of treatment was 6 months
Drug: oral Danshu capsule
UDCA group, 250mg/ was taken orally twice a day (0.25g/, Losan Pharma GmbH company). The course of treatment was 6 months
Drug: oral Danshu capsule
Danshu group oral Danshu capsule, 2 tablets per time, 3 times a day (0.45g/ tablets, Sichuan Jishengtang Pharmaceutical Co., Ltd.)
recurrence rate
abdominal ultrasound or MRCP/CT was used to examine every 3 months after operation for 1 year, and the recurrence was recorded.
Time frame: 1 year
improvement rate of liver function index
5ml of fasting elbow venous blood was taken before treatment and 3 days, 1 week and 2 weeks after treatment respectively. The blood samples were centrifuged and the supernatant was taken. Total bilirubin (total bilirubin, TBil), glutamic pyruvic transaminase (Alanine aminotransferase, ALT), glutamic oxaloacetic transaminase (Aspartate aminotransferase, AST) and γ-glutamyl transpeptidase (γ-glutamyl transpeptidase, GGT)) in blood samples were detected by automatic biochemical analyzer.
Time frame: 3 days, 1 week and 2 weeks
Plan to share: No
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This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
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First People's Hospital of Hangzhou