Overview

Danshu Capsule and Ursodeoxycholic Acid Capsule in Preventing Recurrence of Choledocholithiasis

Status:
Completed
Trial end date:
2019-07-20
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
First People's Hospital of Hangzhou
Criteria
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.