polypoid lesions of gallbladder
Conditions
Interventions
Experimental group:Under lifestyle intervention, Danning Tablet will be taken orally 3 times each day, 5 tablets each time, from baseline to weeks 12±1.
Sponsors
The Third Affiliated Hospital of Naval Medical University (East Hepatobiliary Hospital)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-75 years, no gender limit; 2. Multiple (>=2) polypoid lesions of gallbladder were detected by B-ultrasonography within 2 weeks before inclusion: 3 mm<= maximum polyp diameter <=7 mm; 3. No symptoms, or only some non-specific symptoms: abdominal distension, nausea, anorexia, right upper abdominal dull pain and right shoulder radiating pain; 4. Sign written informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients with gallbladder wall thickness > 6mm; 2. Patients with clinically diagnosed gallbladder cancer; 3. Patients with gallbladder and/or bile duct stones and acute cholecystitis; 4. Patients with gallbladder/biliary tract related operations such as gallbladder-preserving lithotomy, bile duct ERCP lithotomy, PTCS lithotomy or PTGBD; 5. Patients with severe infectious diseases, or with serious primary diseases of cardiovascular and cerebrovascular systems, lung, kidney, endocrine and hematopoietic systems, or with mental diseases or behavioral abnormalities, who are judged by researchers to be unable to conduct this study; 6. Patients with unformed stools in the last 2 weeks, and/or the number of stools >=5 times/day; 7. In the past 4 weeks, patients who regularly take any Chinese patent medicine (including Chinese medicine injection) whose instructions clearly write the words of soothing the liver, improving the gallbladder, clearing heat and clearing the lower body, or the Chinese medicine decoction whose whole prescription effect is soothing the liver and improving the gallbladder; 8. Patients who regularly take proton pump inhibitors, H2 receptor antagonists, cholinergic receptor antagonists, and gastrin receptor antagonists within the last 4 weeks; 9. Patients who are allergic to Daning tablets and its ingredients, have allergic history, allergic constitution or are allergic; 10. Pregnant or lactating patients; 11. Poor compliance, unable to cooperate with the completion of the researcher; 12. Participant in other clinical trials within the last 3 months; 13. Other conditions deemed unsuitable for inclusion by the researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in maximum diameter of gallbladder polyps; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in thickness of gallbladder wall;Changes in clinical symptoms of gallbladder polyps;Blood biochemical indexes;Complete blood count;Urinalysis; | — |
Countries
China
Contacts
Public ContactShen Feng /Yang Tian
The Third Affiliated Hospital of Naval Medical University (East Hepatobiliary Hospital)
Outcome results
None listed