Danshu Capsule and Ursodeoxycholic Acid Capsule in Preventing Recurrence of Choledocholithiasis

Last updated: July 21, 2020
Sponsor: First People's Hospital of Hangzhou
Overall Status: Completed

Phase

4

Condition

Gall Bladder Disorders

Treatment

N/A

Clinical Study ID

NCT04484870
（109）-1
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 Design

Total Participants: 150
Study Start date:
March 01, 2017
Estimated Completion Date:
July 20, 2019

Connect with a study center

  • Hangzhou first people's Hospital

    Hangzhou, Zhejiang 310000
    China

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.