Danshu Capsule and Ursodeoxycholic Acid Capsule in Preventing Recurrence of Choledocholithiasis

Zhejiang University

Status and phase: Completed; Phase 4

Conditions: Choledocholithiasis; Recurrence

Treatments: Drug: oral Danshu capsule

Study type: Interventional

Funder types: Other

Identifiers

NCT04484870

（109）-1

Details and patient eligibility

About

[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.

Enrollment: 150 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Danshu capsule group

Experimental group

Description:

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

Treatment:

Drug: oral Danshu capsule

ursodeoxycholic acid group

Active Comparator group

Description:

UDCA group, 250mg/ was taken orally twice a day (0.25g/, Losan Pharma GmbH company). The course of treatment was 6 months

Treatment:

Drug: oral Danshu capsule