A Study of Danning Tablet in Patients With Polypoid Lesions of Gallbladder
NCT ID: NCT05668871
Last Updated: 2022-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
336 participants
INTERVENTIONAL
2023-01-01
2024-11-30
Brief Summary
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* 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
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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
Intervention and comparison:
1. Test Group (N=168): Under lifestyle intervention, Danning Tablets will be taken orally 3 times each day, 5 tablets each time, from baseline to weeks 12±1.
2. Controlled Group (N=168): Only in treatment of lifestyle intervention.
Clinical Outcomes:
1. Efficacy on shrinkage of gallbladder polyps and alleviation of clinical symptoms of gallbladder polyps.
2. Safety in treatment of gallbladder polyps.
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.
TREATMENT
NONE
Study Groups
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Danning Tablet and lifestyle intervention group
Under lifestyle intervention, Danning Tablet will be taken orally from baseline to weeks 12±1.
Danning Tablet
3 times each day, 5 tablets each time, take orally after meals.
Lifestyle intervention group
Lifestyle intervention only.
No interventions assigned to this group
Interventions
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Danning Tablet
3 times each day, 5 tablets each time, take orally after meals.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. Be between 18 and 75 years of age, male or female.
2. More than or equal to 2 gallbladder polyps were detected by B-ultrasound within 2 weeks before enrollment, and the maximum diameter of gallbladder polyps is between 3-7 mm.
3. No symptoms, or only some non-specific symptoms, such as ventosity, nausea, anorexia, right upper abdominal pain and right shoulder pain, etc.
4. Provide written informed consent.
Exclusion Criteria
1. Thickness of gallbladder wall is larger than 6 mm.
2. Clinically diagnosed as gallbladder cancer.
3. Clinically diagnosed as gallbladder and/or bile duct stones, and/or acute cholecystitis.
4. Previously performed gallbladder/biliary tract related operations, such as gallbladder-protected lithotomy, ERCP lithotomy, PTCS lithotomy and PTGBD.
5. Have severe infectious or severe primary diseases such as diseases in cardiovascular, cerebrovascular, pulmonary, renal or endocrine or hematopoietic system, or with mental diseases and/or behavioral abnormalities, which cannot be enrolled in the study determined by investigator.
6. Have irregular stool, and/or daily stool frequency more than or equal to 5 times in recent 2 weeks.
7. Regularly taken any Chinese patent medicine (including traditional Chinese medicine injection) with "soothing liver, cholagogic, clearing heat, dredging intestines" clearly written in the instructions, or regularly taken the traditional Chinese medicine decoction with the effect of soothing liver and cholagogic in recent 4 weeks.
8. Regularly taken proton pump inhibitors or H2 receptor antagonists or cholinergic receptor antagonists or gastrin receptor antagonists in recent 4 weeks.
9. Allergic to Danning Tablet and its components, has history of allergy, or has allergic constitution, or in allergic state.
10. Are pregnant, planning to be pregnant or breastfeeding.
11. Poor compliance, unable to cooperate with the investigator;
12. Have previously been involved in another clinical trial in the past three month;
13. Other situations not suitable for inclusion.
18 Years
75 Years
ALL
No
Sponsors
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Eastern Hepatobiliary Surgery Hospital
OTHER
Responsible Party
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Shen Feng
Professor and Chief Surgeon
Principal Investigators
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Feng Shen, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Eastern Hepatobiliary Surgery Hospital, Naval Medical University
Tian Yang, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Eastern Hepatobiliary Surgery Hospital, Naval Medical University
Locations
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The Second Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Xiangya Changde Hospital
Changde, Hunan, China
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
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
Eastern Hepatobiliary Surgery Hospital, Naval Medical University,
Shanghai, Shanghai Municipality, China
Shanxi Provincial People's Hospital
Taiyuan, Shanxi, China
The Sixth People's Hospital of Chengdu
Chengdu, Sichuan, China
Anning First People's Hospital
Anning, Yunan, China
Jinhua Municipal Central Hospital
Jinhua, Zhejiang, China
Ningbo Municipal Hospital of Traditional Chinese Medicine
Ningbo, Zhejiang, China
Affiliated Hospital of Shaoxing University
Shaoxing, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Zhigang Pang
Role: primary
Guangfa Xiao
Role: primary
Guodong Chen
Role: primary
Jiaying Xiong
Role: primary
Wei Wu
Role: primary
Nan Yi
Role: primary
Xiao He
Role: primary
Huiqiu Zheng
Role: primary
Shuhong Zhang
Role: primary
Weiwei Liu
Role: primary
Yueping Jiang
Role: primary
Tian Yang
Role: primary
Yu Zhang
Role: primary
Liu Zheng
Role: primary
Qin Wang
Role: primary
Shi'an Yu
Role: primary
Xionghua Wang
Role: primary
Guilin Xie
Role: primary
Other Identifiers
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CCPE202201
Identifier Type: -
Identifier Source: org_study_id