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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
336
3 times each day, 5 tablets each time, take orally after meals.
The Second Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Xiangya Changde Hospital
Changde, Hunan, China
Maximum diameter of gallbladder polyps on weeks 12±1
Use gallbladder ultrasonography to evaluate the maximum diameter of gallbladder polyps.
Time frame: weeks 12±1
Maximum diameter of gallbladder polyps on weeks 24±1
Use gallbladder ultrasonography to evaluate the maximum diameter of gallbladder polyps.
Time frame: weeks 24±1
Thickness of gallbladder wall on weeks 12±1
Use gallbladder ultrasonography to evaluate thickness of gallbladder wall.
Time frame: weeks 12±1
Thickness of gallbladder wall on weeks 24±1
Use gallbladder ultrasonography to evaluate thickness of gallbladder wall.
Time frame: weeks 24±1
Level of abdominal pain on weeks 4±1
Use Visual Analogue Scale (VAS) to evaluate the level of abdominal pain caused by gallbladder polyps.
Time frame: weeks 4±1
Level of abdominal pain on weeks 8±1
Use Visual Analogue Scale (VAS) to evaluate the level of abdominal pain caused by gallbladder polyps.
Time frame: weeks 8±1
Level of abdominal pain on weeks 12±1
Use Visual Analogue Scale (VAS) to evaluate the level of abdominal pain caused by gallbladder polyps.
Time frame: weeks 12±1
Level of abdominal pain on weeks 24±1
Use Visual Analogue Scale (VAS) to evaluate the level of abdominal pain caused by gallbladder polyps.
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The First Affiliated Hospital of University of South China
Hengyang, Hunan, China
Loudi Central Hospital
Loudi, Hunan, China
Yiyang Central Hospital
Yiyang, Hunan, China
Affiliated Hospital of Nantong University
Nantong, Jiangsu, China
First Affiliated Hospital of Gannan Medical University
Ganzhou, Jiangxi, China
Shangrao People's Hospital
Shangrao, Jiangxi, China
Central Hospital Affiliated to Shandong First Medical University (Jinan Central Hospital)
Jinan, Shandong, China
Shandong Provincial Third Hospital
Jinan, Shandong, China
...and 8 more locations
Time frame: weeks 24±1
Clinical safety indexes
Observe and record the occurrence of adverse events (AE) of subjects from baseline to follow-up cycle finished.
Time frame: up to weeks 24±1