NCT05668871

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 336 (estimated)
• Sponsor: Eastern Hepatobiliary Surgery Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The primary goal of this clinical trial is to evaluate the effect of Danning Tablet on shrinkage of gallbladder polyps compared to lifestyle intervention in 336 patients with gallbladder polyps. The main questions it aims to answer are: * Medicine may be effective on shrinkage of gallbladder polyps and alleviation of clinical symptoms of gallbladder polyps. * Chinese patent medicine (herbal medicine) may be safety in treatment of gallbladder polyps.

Detailed description

Study design: In this study, 336 participants will be randomly allocated to the test group or the controlled group in ratio of 1:1 and receive lifestyle intervention from baseline to weeks 24±1. However, in experimental group, participants will take Danning Tablet from baseline to weeks 12±1 (3 times each day, 5 tablets each time). In controlled group, only lifestyle intervention will be adopted. The length of follow-up cycle is 24 weeks. Evaluation indicators: Primary indicator: Changes in maximum diameter of gallbladder polyps, use gallbladder ultrasonography to evaluate this indicator on weeks 12±1 and weeks 24±1. Secondly Indicators: 1. Changes in thickness of gallbladder wall, use gallbladder ultrasonography to evaluate this indicator on weeks 12±1 and weeks 24±1. 2. Changes in clinical symptoms of gallbladder polyps, use Visual Analogue Scale (VAS) to evaluate this indicator on weeks 12±1 and weeks 24±1. 3. Clinical safety indexes, use laboratory examination such as blood biochemical examination, routine blood test for safety observation on weeks 12±1 and weeks 24±1. Besides, observe and record the occurrence of adverse events (AE) of subjects from baseline to follow-up cycle finished.

Conditions

• Polyps Gallbladder

Interventions

Type	Name	Description
DRUG	Danning Tablet	3 times each day, 5 tablets each time, take orally after meals.

Timeline

• Start date: 2023-01-01
• Primary completion: 2024-08-31
• Completion: 2024-11-30
• First posted: 2022-12-30
• Last updated: 2022-12-30

Locations

18 sites across 1 country: China