A Study of Danning Tablet in Patients With Polypoid Lesions of Gallbladder

Effects of Danning Tablet Under Lifestyle Intervention in Patients With Polypoid Lesions of Gallbladder: A Randomized, Open-labelled, Multicenter, Controlled Trial

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.

Study design:

The study will be conducted in phases over a 6-month period, with participants being randomly assigned to either the intervention group (receiving Danning Tablets plus standard care) or the control group (receiving standard care alone). The study will involve multiple follow-up visits for participants at key intervals: baseline (in-person visit), and then follow-ups at the 4th week (telephone), 8th week (telephone), 12th week (in-person), and 24th week (in-person).

Endpoints:

Primary endpoints: Clinical efficacy rate at the 24th week following medication commencement Efficacy is determined based on the proportion of patients who experience a reduction in the size of the largest polyp or complete polyp resolution, as assessed by ultrasound.

Secondary Endpoints:

1. Symptom Relief Rate: This rate evaluates the improvement in symptoms such as abdominal distension, nausea, anorexia, upper right abdominal pain, and radiating right shoulder pain. Improvement is measured using the Visual Analogue Scale (VAS) scores, with a decrease in score indicating symptom relief.
2. Disease Progression Rate: Assessed by the increase in the size of the largest polyp (≥2 mm in diameter)
3. Incidence of Adverse Events/Reactions

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.