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Completed
NCT05668871
A Study of Danning Tablet in Patients With Polypoid Lesions of Gallbladder
Conditions: Multiple Gallbladder Polyps
Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: No
Phase: PHASE4
Enrollment: 326
Sponsor: Eastern Hepatobiliary Surgery Hospital
Location: Hebei general hospital Shijiazhuang Hebei
Summary
The primary aim of this study is to evaluate the efficacy and safety of Danning Tablets in the treatment of MGPs. Specifically, the study seeks to determine whether Danning Tablets, when used alongside standard care, can effectively reduce the size of MGPs and improve related symptoms.
Eligibility Criteria
Inclusion Criteria:
Participants suitable for enrollment in this study must meet all of the following criteria:
1. Adults aged 18-75 years, both male and female.
2. Diagnosed with multiple gallbladder polyps (≥2 polyps) based on ultrasound examinations within 2 weeks before enrolment, with largest polyps measuring between 3 mm and 7 mm in diameter.
3. Participants with non-specific or without symptoms related to gallpladder polyps, such as ventosity, nausea, anorexia, right upper abdominal pain, and right shoulder radiating pain, etc.
4. Ability to understand and willingness to sign a written informed consent document.
Exclusion Criteria:
Participants who meet any of the following criteria will not be eligible for inclusion in this study:
1. Clinical diagnosis of gallbladder cancer, and/or gallbladder/bile duct stones, and/or acute cholecystitis.
2. Previous gallbladder/biliary tract surgery, such as gallbladder-preserving cholecystolithotomy, lithotomy by endoscopic retrograde cholangiopancreatography (ERCP) or percutaneous transhepatic cholangiography (PTC), etc.
3. Thickness of gallbladder wall \>6 mm based on ultrasound examinations.
4. Severe comorbid conditions, including active severe infectious or severe primary cardiovascular, cerebrovascular, pulmonary, renal, endocrine, or hematopoietic disease, or with mental disorders and/or behavioural abnormalities.
5. Irregular stool and/or stool evacuation frequency ≥5 times/day within 2 weeks before enrolment.
6. Regularly taking any Chinese patent medicine (including TCM injection) with "soothing liver, cholagogic, clearing heat, dredging intestines" clearly written in the instructions, or regularly taking the TCM decoction with the effect of soothing liver and cholagogic within 4 weeks before enrolment.
7. Currently receiving other pharmacological treatments for MGPs.
8. Regularly taking proton pump inhibitors or H2-receptor antagonists, cholinergic receptor antagonists or gastrin receptor antagonists within 4 weeks before enrolment.
9. Pregnancy or lactation: Women who are pregnant, planning to become pregnant, or breastfeeding.
10. Allergies: Participants with known hypersensitivity to any components of Danning Tablets.
11. Poor patient compliance or being unable to cooperate with the investigator.
12. Participation in another trial within 3 months before enrolment.
13. Any other situations not suitable for inclusion.
Source: ClinicalTrials.gov (NCT05668871). StuddyBuddy aggregates publicly available trial information.