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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:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Danning Tablet and lifestyle intervention group | Experimental | Under lifestyle intervention, Danning Tablet will be taken orally from baseline to weeks 12±1. |
|
| Lifestyle intervention group | No Intervention | Lifestyle intervention only. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Danning Tablet | Drug | 3 times each day, 5 tablets each time, take orally after meals. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum diameter of gallbladder polyps on weeks 12±1 | Use gallbladder ultrasonography to evaluate the maximum diameter of gallbladder polyps. | weeks 12±1 |
| Maximum diameter of gallbladder polyps on weeks 24±1 | Use gallbladder ultrasonography to evaluate the maximum diameter of gallbladder polyps. | weeks 24±1 |
| Measure | Description | Time Frame |
|---|---|---|
| Thickness of gallbladder wall on weeks 12±1 | Use gallbladder ultrasonography to evaluate thickness of gallbladder wall. | weeks 12±1 |
| Thickness of gallbladder wall on weeks 24±1 | Use gallbladder ultrasonography to evaluate thickness of gallbladder wall. |
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Inclusion Criteria:
Participants suitable for enrollment in this study must meet all of the following criteria:
Exclusion Criteria:
Participants who meet any of the following criteria will not be eligible for inclusion in this study:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tian Yang | Contact | +8613636330827 | yangtian6666@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Feng Shen, MD, PhD | Eastern Hepatobiliary Surgery Hospital, Naval Medical University | Principal Investigator |
| Tian Yang, MD, PhD | Eastern Hepatobiliary Surgery Hospital, Naval Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital of Zhengzhou University | Zhengzhou | Henan | 0086371 | China |
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| ID | Term |
|---|---|
| D011127 | Polyps |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Target population: Patients with multiple gallbladder polyps.
Intervention and comparison:
Clinical Outcomes:
Follow-up cycle: The length of follow-up cycle is 24 weeks, 5 visit windows (baseline, weeks 4±1, weeks 8±1, weeks 12±1, weeks 24±1) are set.
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Open-labelled clinical trial, no masking involved.
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| 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. | 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. | 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. | 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. | weeks 24±1 |
| Clinical safety indexes | Observe and record the occurrence of adverse events (AE) of subjects from baseline to follow-up cycle finished. | up to weeks 24±1 |
| Xiangya Changde Hospital | Changde | Hunan | 0086736 | China |
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| The First Affiliated Hospital of University of South China | Hengyang | Hunan | 0086734 | China |
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| Loudi Central Hospital | Loudi | Hunan | 0086738 | China |
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| Yiyang Central Hospital | Yiyang | Hunan | 0086737 | China |
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| Affiliated Hospital of Nantong University | Nantong | Jiangsu | 0086513 | China |
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| First Affiliated Hospital of Gannan Medical University | Ganzhou | Jiangxi | 0086797 | China |
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| Shangrao People's Hospital | Shangrao | Jiangxi | 0086793 | China |
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| Central Hospital Affiliated to Shandong First Medical University (Jinan Central Hospital) | Jinan | Shandong | 0086531 | China |
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| Shandong Provincial Third Hospital | Jinan | Shandong | 0086531 | China |
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| The Affiliated Hospital of Qingdao University | Qingdao | Shandong | 0086532 | China |
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| Eastern Hepatobiliary Surgery Hospital, Naval Medical University, | Shanghai | Shanghai Municipality | 0086021 | China |
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| Shanxi Provincial People's Hospital | Taiyuan | Shanxi | 0086351 | China |
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| The Sixth People's Hospital of Chengdu | Chengdu | Sichuan | 0086028 | China |
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| Anning First People's Hospital | Anning | Yunan | 0086871 | China |
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| Jinhua Municipal Central Hospital | Jinhua | Zhejiang | 0086579 | China |
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| Ningbo Municipal Hospital of Traditional Chinese Medicine | Ningbo | Zhejiang | 0086574 | China |
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| Affiliated Hospital of Shaoxing University | Shaoxing | Zhejiang | 0086575 | China |
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