Danshu Capsule and Ursodeoxycholic Acid Capsule in Preventing Recurrence of Choledocholithiasis

NCT04484870 | Completed Phase 4 DMC

• 1 other identifier: （109）-1
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

\[objective\] 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.

Conditions

Choledocholithiasis; Recurrence

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• improvement rate of liver function index

  3 days, 1 week and 2 weeks

Study Arms (2)

Danshu capsule group

EXPERIMENTAL

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

ursodeoxycholic acid group

ACTIVE COMPARATOR

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

Interventions

oral Danshu capsule DRUG

Danshu group oral Danshu capsule, 2 tablets per time, 3 times a day (0.45g/ tablets, Sichuan Jishengtang Pharmaceutical Co., Ltd.)

Danshu capsule group; ursodeoxycholic acid group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• First People's Hospital of Hangzhou: lead

Study Sites (1)

Hangzhou first people's Hospital

Hangzhou, Zhejiang, 310000, China

Location

MeSH Terms

Conditions

Choledocholithiasis; Recurrence

Condition Hierarchy (Ancestors)

Common Bile Duct Diseases; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Cholelithiasis; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Xiaofeng Zhang, Zhang

  First People's Hospital of Hangzhou

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department of Gastroenterology

Study Record Dates

• First Submitted: July 21, 2020
• First Posted: July 24, 2020
• Study Start: March 1, 2017
• Primary Completion: July 30, 2018
• Study Completion: July 20, 2019
• Last Updated: July 24, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)