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A Study of Danning Tablet in Patients With Polypoid Lesions of Gallbladder (PLG001)

Primary Purpose

Polyps Gallbladder

Status
Not yet recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Danning Tablet
Sponsored by
Eastern Hepatobiliary Surgery Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polyps Gallbladder focused on measuring gallbladder, polyps, healthy lifestyle, herbal medicine, Danning Tablet

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Participants suitable for enrollment in this study must meet all of the following criteria: Be between 18 and 75 years of age, male or female. 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. No symptoms, or only some non-specific symptoms, such as ventosity, nausea, anorexia, right upper abdominal pain and right shoulder pain, etc. Provide written informed consent. Exclusion Criteria: Participants who meet any of the following criteria will not be eligible for inclusion in this study: Thickness of gallbladder wall is larger than 6 mm. Clinically diagnosed as gallbladder cancer. Clinically diagnosed as gallbladder and/or bile duct stones, and/or acute cholecystitis. Previously performed gallbladder/biliary tract related operations, such as gallbladder-protected lithotomy, ERCP lithotomy, PTCS lithotomy and PTGBD. 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. Have irregular stool, and/or daily stool frequency more than or equal to 5 times in recent 2 weeks. 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. Regularly taken proton pump inhibitors or H2 receptor antagonists or cholinergic receptor antagonists or gastrin receptor antagonists in recent 4 weeks. Allergic to Danning Tablet and its components, has history of allergy, or has allergic constitution, or in allergic state. Are pregnant, planning to be pregnant or breastfeeding. Poor compliance, unable to cooperate with the investigator; Have previously been involved in another clinical trial in the past three month; Other situations not suitable for inclusion.

Sites / Locations

  • The Second Affiliated Hospital of Zhengzhou University
  • Xiangya Changde Hospital
  • The First Affiliated Hospital of University of South China
  • Loudi Central Hospital
  • Yiyang Central Hospital
  • Affiliated Hospital of Nantong University
  • First Affiliated Hospital of Gannan Medical University
  • Shangrao People's Hospital
  • Central Hospital Affiliated to Shandong First Medical University (Jinan Central Hospital)
  • Shandong Provincial Third Hospital
  • The Affiliated Hospital of Qingdao University
  • Eastern Hepatobiliary Surgery Hospital, Naval Medical University,
  • Shanxi Provincial People's Hospital
  • The Sixth People's Hospital of Chengdu
  • Anning First People's Hospital
  • Jinhua Municipal Central Hospital
  • Ningbo Municipal Hospital of Traditional Chinese Medicine
  • Affiliated Hospital of Shaoxing University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Danning Tablet and lifestyle intervention group

Lifestyle intervention group

Arm Description

Under lifestyle intervention, Danning Tablet will be taken orally from baseline to weeks 12±1.

Lifestyle intervention only.

Outcomes

Primary Outcome Measures

Maximum diameter of gallbladder polyps on weeks 12±1
Use gallbladder ultrasonography to evaluate the maximum diameter of gallbladder polyps.
Maximum diameter of gallbladder polyps on weeks 24±1
Use gallbladder ultrasonography to evaluate the maximum diameter of gallbladder polyps.

Secondary Outcome Measures

Thickness of gallbladder wall on weeks 12±1
Use gallbladder ultrasonography to evaluate thickness of gallbladder wall.
Thickness of gallbladder wall on weeks 24±1
Use gallbladder ultrasonography to evaluate thickness of gallbladder wall.
Level of abdominal pain on weeks 4±1
Use Visual Analogue Scale (VAS) to evaluate the level of abdominal pain caused by gallbladder polyps.
Level of abdominal pain on weeks 8±1
Use Visual Analogue Scale (VAS) to evaluate the level of abdominal pain caused by gallbladder polyps.
Level of abdominal pain on weeks 12±1
Use Visual Analogue Scale (VAS) to evaluate the level of abdominal pain caused by gallbladder polyps.
Level of abdominal pain on weeks 24±1
Use Visual Analogue Scale (VAS) to evaluate the level of abdominal pain caused by gallbladder polyps.
Clinical safety indexes
Observe and record the occurrence of adverse events (AE) of subjects from baseline to follow-up cycle finished.

Full Information

First Posted
December 14, 2022
Last Updated
December 25, 2022
Sponsor
Eastern Hepatobiliary Surgery Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05668871
Brief Title
A Study of Danning Tablet in Patients With Polypoid Lesions of Gallbladder
Acronym
PLG001
Official Title
Effects of Danning Tablet Under Lifestyle Intervention in Patients With Polypoid Lesions of Gallbladder: A Randomized, Open-labelled, Multicenter, Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 1, 2023 (Anticipated)
Primary Completion Date
August 31, 2024 (Anticipated)
Study Completion Date
November 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Eastern Hepatobiliary Surgery Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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: Changes in thickness of gallbladder wall, use gallbladder ultrasonography to evaluate this indicator on weeks 12±1 and weeks 24±1. Changes in clinical symptoms of gallbladder polyps, use Visual Analogue Scale (VAS) to evaluate this indicator on weeks 12±1 and weeks 24±1. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polyps Gallbladder
Keywords
gallbladder, polyps, healthy lifestyle, herbal medicine, Danning Tablet

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Target population: Patients with multiple gallbladder polyps. Intervention and comparison: 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. Controlled Group (N=168): Only in treatment of lifestyle intervention. Clinical Outcomes: Efficacy on shrinkage of gallbladder polyps and alleviation of clinical symptoms of gallbladder polyps. 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.
Masking
None (Open Label)
Masking Description
Open-labelled clinical trial, no masking involved.
Allocation
Randomized
Enrollment
336 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Danning Tablet and lifestyle intervention group
Arm Type
Experimental
Arm Description
Under lifestyle intervention, Danning Tablet will be taken orally from baseline to weeks 12±1.
Arm Title
Lifestyle intervention group
Arm Type
No Intervention
Arm Description
Lifestyle intervention only.
Intervention Type
Drug
Intervention Name(s)
Danning Tablet
Other Intervention Name(s)
Biliflow (NPN 80073325, manufactured by Shanghai Hutchison Pharmaceuticals Limited)
Intervention Description
3 times each day, 5 tablets each time, take orally after meals.
Primary Outcome Measure Information:
Title
Maximum diameter of gallbladder polyps on weeks 12±1
Description
Use gallbladder ultrasonography to evaluate the maximum diameter of gallbladder polyps.
Time Frame
weeks 12±1
Title
Maximum diameter of gallbladder polyps on weeks 24±1
Description
Use gallbladder ultrasonography to evaluate the maximum diameter of gallbladder polyps.
Time Frame
weeks 24±1
Secondary Outcome Measure Information:
Title
Thickness of gallbladder wall on weeks 12±1
Description
Use gallbladder ultrasonography to evaluate thickness of gallbladder wall.
Time Frame
weeks 12±1
Title
Thickness of gallbladder wall on weeks 24±1
Description
Use gallbladder ultrasonography to evaluate thickness of gallbladder wall.
Time Frame
weeks 24±1
Title
Level of abdominal pain on weeks 4±1
Description
Use Visual Analogue Scale (VAS) to evaluate the level of abdominal pain caused by gallbladder polyps.
Time Frame
weeks 4±1
Title
Level of abdominal pain on weeks 8±1
Description
Use Visual Analogue Scale (VAS) to evaluate the level of abdominal pain caused by gallbladder polyps.
Time Frame
weeks 8±1
Title
Level of abdominal pain on weeks 12±1
Description
Use Visual Analogue Scale (VAS) to evaluate the level of abdominal pain caused by gallbladder polyps.
Time Frame
weeks 12±1
Title
Level of abdominal pain on weeks 24±1
Description
Use Visual Analogue Scale (VAS) to evaluate the level of abdominal pain caused by gallbladder polyps.
Time Frame
weeks 24±1
Title
Clinical safety indexes
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participants suitable for enrollment in this study must meet all of the following criteria: Be between 18 and 75 years of age, male or female. 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. No symptoms, or only some non-specific symptoms, such as ventosity, nausea, anorexia, right upper abdominal pain and right shoulder pain, etc. Provide written informed consent. Exclusion Criteria: Participants who meet any of the following criteria will not be eligible for inclusion in this study: Thickness of gallbladder wall is larger than 6 mm. Clinically diagnosed as gallbladder cancer. Clinically diagnosed as gallbladder and/or bile duct stones, and/or acute cholecystitis. Previously performed gallbladder/biliary tract related operations, such as gallbladder-protected lithotomy, ERCP lithotomy, PTCS lithotomy and PTGBD. 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. Have irregular stool, and/or daily stool frequency more than or equal to 5 times in recent 2 weeks. 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. Regularly taken proton pump inhibitors or H2 receptor antagonists or cholinergic receptor antagonists or gastrin receptor antagonists in recent 4 weeks. Allergic to Danning Tablet and its components, has history of allergy, or has allergic constitution, or in allergic state. Are pregnant, planning to be pregnant or breastfeeding. Poor compliance, unable to cooperate with the investigator; Have previously been involved in another clinical trial in the past three month; Other situations not suitable for inclusion.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tian Yang
Phone
+8613636330827
Email
yangtian6666@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Feng Shen, MD, PhD
Organizational Affiliation
Eastern Hepatobiliary Surgery Hospital, Naval Medical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tian Yang, MD, PhD
Organizational Affiliation
Eastern Hepatobiliary Surgery Hospital, Naval Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Second Affiliated Hospital of Zhengzhou University
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
0086371
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhigang Pang
First Name & Middle Initial & Last Name & Degree
Zhigang Pang
Facility Name
Xiangya Changde Hospital
City
Changde
State/Province
Hunan
ZIP/Postal Code
0086736
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guangfa Xiao
First Name & Middle Initial & Last Name & Degree
Guangfa Xiao
Facility Name
The First Affiliated Hospital of University of South China
City
Hengyang
State/Province
Hunan
ZIP/Postal Code
0086734
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guodong Chen
First Name & Middle Initial & Last Name & Degree
Guodong Chen
Facility Name
Loudi Central Hospital
City
Loudi
State/Province
Hunan
ZIP/Postal Code
0086738
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiaying Xiong
First Name & Middle Initial & Last Name & Degree
Jiaying Xiong
Facility Name
Yiyang Central Hospital
City
Yiyang
State/Province
Hunan
ZIP/Postal Code
0086737
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei Wu
First Name & Middle Initial & Last Name & Degree
Wei Wu
Facility Name
Affiliated Hospital of Nantong University
City
Nantong
State/Province
Jiangsu
ZIP/Postal Code
0086513
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nan Yi
First Name & Middle Initial & Last Name & Degree
Nan Yi
Facility Name
First Affiliated Hospital of Gannan Medical University
City
Ganzhou
State/Province
Jiangxi
ZIP/Postal Code
0086797
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiao He
First Name & Middle Initial & Last Name & Degree
Xiao He
Facility Name
Shangrao People's Hospital
City
Shangrao
State/Province
Jiangxi
ZIP/Postal Code
0086793
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huiqiu Zheng
First Name & Middle Initial & Last Name & Degree
Huiqiu Zheng
Facility Name
Central Hospital Affiliated to Shandong First Medical University (Jinan Central Hospital)
City
Jinan
State/Province
Shandong
ZIP/Postal Code
0086531
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shuhong Zhang
First Name & Middle Initial & Last Name & Degree
Shuhong Zhang
Facility Name
Shandong Provincial Third Hospital
City
Jinan
State/Province
Shandong
ZIP/Postal Code
0086531
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weiwei Liu
First Name & Middle Initial & Last Name & Degree
Weiwei Liu
Facility Name
The Affiliated Hospital of Qingdao University
City
Qingdao
State/Province
Shandong
ZIP/Postal Code
0086532
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yueping Jiang
First Name & Middle Initial & Last Name & Degree
Yueping Jiang
Facility Name
Eastern Hepatobiliary Surgery Hospital, Naval Medical University,
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
0086021
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tian Yang
Phone
+8613636330827
Email
yangtian6666@hotmail.com
First Name & Middle Initial & Last Name & Degree
Feng Shen, MD, PhD
First Name & Middle Initial & Last Name & Degree
Tian Yang, MD, PhD
Facility Name
Shanxi Provincial People's Hospital
City
Taiyuan
State/Province
Shanxi
ZIP/Postal Code
0086351
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yu Zhang
First Name & Middle Initial & Last Name & Degree
Yu Zhang
Facility Name
The Sixth People's Hospital of Chengdu
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
0086028
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liu Zheng
First Name & Middle Initial & Last Name & Degree
Liu Zheng
Facility Name
Anning First People's Hospital
City
Anning
State/Province
Yunan
ZIP/Postal Code
0086871
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qin Wang
First Name & Middle Initial & Last Name & Degree
Qin Wang
Facility Name
Jinhua Municipal Central Hospital
City
Jinhua
State/Province
Zhejiang
ZIP/Postal Code
0086579
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shi'an Yu
First Name & Middle Initial & Last Name & Degree
Shi'an Yu
Facility Name
Ningbo Municipal Hospital of Traditional Chinese Medicine
City
Ningbo
State/Province
Zhejiang
ZIP/Postal Code
0086574
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xionghua Wang
First Name & Middle Initial & Last Name & Degree
Xionghua Wang
Facility Name
Affiliated Hospital of Shaoxing University
City
Shaoxing
State/Province
Zhejiang
ZIP/Postal Code
0086575
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guilin Xie
First Name & Middle Initial & Last Name & Degree
Guilin Xie

12. IPD Sharing Statement

Learn more about this trial

A Study of Danning Tablet in Patients With Polypoid Lesions of Gallbladder

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