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

Effects of Danning Tablet Under Lifestyle Intervention in Patients With Polypoid Lesions of Gallbladder: A Randomized, Open-labelled, Multicenter, Controlled Trial

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 Overview

• Status: Not yet recruiting
• Conditions: Polyps Gallbladder
• Intervention / Treatment: Drug: Danning Tablet

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.

• Study Type: Interventional
• Enrollment (Anticipated): 336
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Tian Yang; Phone Number: +8613636330827; Email: yangtian6666@hotmail.com

Study Locations

• China
  • Henan
    • Zhengzhou, Henan, China, 0086371
      • The Second Affiliated Hospital of Zhengzhou University
      • Contact: Zhigang Pang
      • Principal Investigator: Zhigang Pang
  • Hunan
    • Changde, Hunan, China, 0086736
      • Xiangya Changde Hospital
      • Contact: Guangfa Xiao
      • Principal Investigator: Guangfa Xiao
    • Hengyang, Hunan, China, 0086734
      • The First Affiliated Hospital of University of South China
      • Contact: Guodong Chen
      • Principal Investigator: Guodong Chen
    • Loudi, Hunan, China, 0086738
      • Loudi Central Hospital
      • Contact: Jiaying Xiong
      • Principal Investigator: Jiaying Xiong
    • Yiyang, Hunan, China, 0086737
      • Yiyang Central Hospital
      • Principal Investigator: Wei Wu
  • Jiangsu
    • Nantong, Jiangsu, China, 0086513
      • Affiliated Hospital of Nantong University
      • Contact: Nan Yi
      • Principal Investigator: Nan Yi
  • Jiangxi
    • Ganzhou, Jiangxi, China, 0086797
      • First Affiliated Hospital of Gannan Medical University
      • Contact: Xiao He
      • Principal Investigator: Xiao He
    • Shangrao, Jiangxi, China, 0086793
      • Shangrao People's Hospital
      • Contact: Huiqiu Zheng
      • Principal Investigator: Huiqiu Zheng
  • Shandong
    • Jinan, Shandong, China, 0086531
      • Central Hospital Affiliated to Shandong First Medical University (Jinan Central Hospital)
      • Contact: Shuhong Zhang
      • Principal Investigator: Shuhong Zhang
    • Jinan, Shandong, China, 0086531
      • Shandong Provincial Third Hospital
      • Contact: Weiwei Liu
      • Principal Investigator: Weiwei Liu
    • Qingdao, Shandong, China, 0086532
      • The Affiliated Hospital of Qingdao University
      • Contact: Yueping Jiang
      • Principal Investigator: Yueping Jiang
  • Shanghai
    • Shanghai, Shanghai, China, 0086021
      • Eastern Hepatobiliary Surgery Hospital, Naval Medical University,
      • Contact: Tian Yang; Phone Number: +8613636330827; Email: yangtian6666@hotmail.com
      • Principal Investigator: Feng Shen, MD, PhD
      • Principal Investigator: Tian Yang, MD, PhD
  • Shanxi
    • Taiyuan, Shanxi, China, 0086351
      • Shanxi Provincial People's Hospital
      • Contact: Yu Zhang
      • Principal Investigator: Yu Zhang
  • Sichuan
    • Chengdu, Sichuan, China, 0086028
      • The Sixth People's Hospital of Chengdu
      • Contact: Liu Zheng
      • Principal Investigator: Liu Zheng
  • Yunan
    • Anning, Yunan, China, 0086871
      • Anning First People's Hospital
      • Contact: Qin Wang
      • Principal Investigator: Qin Wang
  • Zhejiang
    • Jinhua, Zhejiang, China, 0086579
      • Jinhua Municipal Central Hospital
      • Contact: Shi'an Yu
      • Principal Investigator: Shi'an Yu
    • Ningbo, Zhejiang, China, 0086574
      • Ningbo Municipal Hospital of Traditional Chinese Medicine
      • Contact: Xionghua Wang
      • Principal Investigator: Xionghua Wang
    • Shaoxing, Zhejiang, China, 0086575
      • Affiliated Hospital of Shaoxing University
      • Contact: Guilin Xie
      • Principal Investigator: Guilin Xie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Participants suitable for enrollment in this study must meet all of the following 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:

Participants who meet any of the following criteria will not be eligible for inclusion in this study:

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Danning Tablet and lifestyle intervention group; Under lifestyle intervention, Danning Tablet will be taken orally from baseline to weeks 12±1.	Drug: Danning Tablet; 3 times each day, 5 tablets each time, take orally after meals.; Other Names: Biliflow (NPN 80073325, manufactured by Shanghai Hutchison Pharmaceuticals Limited)
No Intervention: Lifestyle intervention group; Lifestyle intervention only.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: Eastern Hepatobiliary Surgery Hospital
• Investigators: Principal Investigator: Feng Shen, MD, PhD, Eastern Hepatobiliary Surgery Hospital, Naval Medical University; Principal Investigator: Tian Yang, MD, PhD, Eastern Hepatobiliary Surgery Hospital, Naval Medical University

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2023
• Primary Completion (Anticipated): August 31, 2024
• Study Completion (Anticipated): November 30, 2024

Study Registration Dates

• First Submitted: December 14, 2022
• First Submitted That Met QC Criteria: December 25, 2022
• First Posted (Actual): December 30, 2022

Study Record Updates

• Last Update Posted (Actual): December 30, 2022
• Last Update Submitted That Met QC Criteria: December 25, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: healthy lifestyle; polyps; herbal medicine; gallbladder; Danning Tablet
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Polyps
• Other Study ID Numbers: CCPE202201

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No