Danshu Capsule and Ursodeoxycholic Acid Capsule in Preventing Recurrence of Choledocholithiasis

Recurrence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04484870
• Other study ID #: (109)-1
• Status: Completed
• Phase: Phase 4
• Start date: March 1, 2017
• Est. completion date: July 20, 2019

Study information

• Verified date: July 2020
• Source: First People's Hospital of Hangzhou
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: July 20, 2019
• Est. primary completion date: July 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Choledocholithiasis
• Recurrence

Intervention

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.)

Locations

Country	Name	City	State
China	Hangzhou first people's Hospital	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
First People's Hospital of Hangzhou

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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 ?-glutamyl transpeptidase (?-glutamyl transpeptidase, GGT)) in blood samples were detected by automatic biochemical analyzer.	3 days, 1 week and 2 weeks