A Study of Danning Tablet in Patients With Polypoid Lesions of Gallbladder (NCT05668871) | Clinical Trial Compass
CompletedPhase 4
A Study of Danning Tablet in Patients With Polypoid Lesions of Gallbladder
China326 participantsStarted 2022-12-01
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Adults aged 18-75 years, both male and female.
. 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.
. 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.
. Ability to understand and willingness to sign a written informed consent document.
. Previous gallbladder/biliary tract surgery, such as gallbladder-preserving cholecystolithotomy, lithotomy by endoscopic retrograde cholangiopancreatography (ERCP) or percutaneous transhepatic cholangiography (PTC), etc.
. Thickness of gallbladder wall \>6 mm based on ultrasound examinations.
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Clinical Efficacy Rate
Timeframe: From enrollment to the end of treatment at 24 weeks
. Irregular stool and/or stool evacuation frequency ≥5 times/day within 2 weeks before enrolment.
. 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.
. Currently receiving other pharmacological treatments for MGPs.
. Regularly taking proton pump inhibitors or H2-receptor antagonists, cholinergic receptor antagonists or gastrin receptor antagonists within 4 weeks before enrolment.