Danshu Capsule and Ursodeoxycholic Acid Capsule in Preventing Recurrence of Choledocholithiasis

Comparative Study on the Efficacy of Danshu Capsule and Ursodeoxycholic Acid Capsule in Preventing Recurrence of Choledocholithiasis

[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.

Study Overview

• Status: Completed
• Conditions: Recurrence; Choledocholithiasis
• Intervention / Treatment: Drug: oral Danshu capsule

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • Hangzhou First People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

inclusion criteria:

1. Choledocholithiasis was diagnosed by B-ultrasound / CT/MRCP, The patients are generally in good condition, no surgical taboos, and can tolerate general anesthesia and ERCP surgery.
2. Agree to participate in the project research, know the benefits and possible risks of surgery, know the benefits and risks of drugs, and sign an informed consent form.

exclusion criteria：

1. patients with cholecystolithiasis, hepatitis B, biliary ascariasis, liver cirrhosis, hemolytic anemia, congenital jaundice and tumor were excluded.
2. Excluding serious primary diseases such as heart, brain, lung, kidney and blood system.
3. Those who are allergic or allergic to drugs in this test are excluded.
4. Pregnancy vibration or nursing women were excluded.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Danshu capsule group; 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; Danshu group oral Danshu capsule, 2 tablets per time, 3 times a day (0.45g/ tablets, Sichuan Jishengtang Pharmaceutical Co., Ltd.)
Active Comparator: ursodeoxycholic acid group; 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.)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
recurrence rate	abdominal ultrasound or MRCP/CT was used to examine every 3 months after operation for 1 year, and the recurrence was recorded.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 days, 1 week and 2 weeks

Collaborators and Investigators

• Sponsor: First People's Hospital of Hangzhou
• Investigators: Study Director: Xiaofeng Zhang, Zhang, First People's Hospital of Hangzhou

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2017
• Primary Completion (Actual): July 30, 2018
• Study Completion (Actual): July 20, 2019

Study Registration Dates

• First Submitted: July 21, 2020
• First Submitted That Met QC Criteria: July 21, 2020
• First Posted (Actual): July 24, 2020

Study Record Updates

• Last Update Posted (Actual): July 24, 2020
• Last Update Submitted That Met QC Criteria: July 21, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease Attributes; Biliary Tract Diseases; Bile Duct Diseases; Common Bile Duct Diseases; Cholelithiasis; Recurrence; Choledocholithiasis
• Other Study ID Numbers: （109）-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No