Danshu Capsule and Ursodeoxycholic Acid Capsule in Preventing Recurrence of Choledocholithiasis

[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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hangzhou first people's Hospital

Hangzhou, Zhejiang, 310000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

：

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.

Treatment and study plan

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.)

Primary outcomes

recurrence rate

Time frame: 1 year

abdominal ultrasound or MRCP/CT was used to examine every 3 months after operation for 1 year, and the recurrence was recorded.

Secondary outcomes

improvement rate of liver function index

Time frame: 3 days, 1 week and 2 weeks

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 γ-glutamyl transpeptidase (γ-glutamyl transpeptidase, GGT)) in blood samples were detected by automatic biochemical analyzer.

Sponsors and collaborators

Lead sponsor

First People's Hospital of Hangzhou

Other

Registry information

Official study title

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

Important dates

Study start: 2017
Primary completion: 2018
Study completion: 2019
First posted: Jul 24, 2020
Registry last updated: Jul 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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