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

NCT05668871 | Unknown Phase 4 DMC

• 1 other identifier: CCPE202201
• Study Type: interventional
• Target: 336
• Locations: 1 country
• Sites: 18

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.

Conditions

Polyps Gallbladder

Keywords

gallbladder; polyps; healthy lifestyle; herbal medicine; Danning Tablet

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• Thickness of gallbladder wall on weeks 12±1

  weeks 12±1

• Thickness of gallbladder wall on weeks 24±1

  weeks 24±1

• Level of abdominal pain on weeks 4±1

  weeks 4±1

• Level of abdominal pain on weeks 8±1

  weeks 8±1

• Level of abdominal pain on weeks 12±1

  weeks 12±1

Study Arms (2)

Danning Tablet and lifestyle intervention group

EXPERIMENTAL

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

Drug: Danning Tablet

Lifestyle intervention group

NO INTERVENTION

Lifestyle intervention only.

Interventions

Danning Tablet DRUG

3 times each day, 5 tablets each time, take orally after meals.

Also known as: Biliflow (NPN 80073325, manufactured by Shanghai Hutchison Pharmaceuticals Limited)

Danning Tablet and lifestyle intervention group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Eastern Hepatobiliary Surgery Hospital: lead

Study Sites (18)

The Second Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 0086371, China

Location

Xiangya Changde Hospital

Changde, Hunan, 0086736, China

Location

The First Affiliated Hospital of University of South China

Hengyang, Hunan, 0086734, China

Location

Loudi Central Hospital

Loudi, Hunan, 0086738, China

Location

Yiyang Central Hospital

Yiyang, Hunan, 0086737, China

Location

Affiliated Hospital of Nantong University

Nantong, Jiangsu, 0086513, China

Location

First Affiliated Hospital of Gannan Medical University

Ganzhou, Jiangxi, 0086797, China

Location

Shangrao People's Hospital

Shangrao, Jiangxi, 0086793, China

Location

Central Hospital Affiliated to Shandong First Medical University (Jinan Central Hospital)

Jinan, Shandong, 0086531, China

Location

Shandong Provincial Third Hospital

Jinan, Shandong, 0086531, China

Location

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, 0086532, China

Location

Eastern Hepatobiliary Surgery Hospital, Naval Medical University,

Shanghai, Shanghai Municipality, 0086021, China

Location

Shanxi Provincial People's Hospital

Taiyuan, Shanxi, 0086351, China

Location

The Sixth People's Hospital of Chengdu

Chengdu, Sichuan, 0086028, China

Location

Anning First People's Hospital

Anning, Yunan, 0086871, China

Location

Jinhua Municipal Central Hospital

Jinhua, Zhejiang, 0086579, China

Location

Ningbo Municipal Hospital of Traditional Chinese Medicine

Ningbo, Zhejiang, 0086574, China

Location

Affiliated Hospital of Shaoxing University

Shaoxing, Zhejiang, 0086575, China

Location

MeSH Terms

Conditions

Polyps

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• 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

Central Study Contacts

Tian Yang

CONTACT

+8613636330827; yangtian6666@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Open-labelled clinical trial, no masking involved.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chief Surgeon

Model Details: Target population: Patients with multiple gallbladder polyps. 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.

Study Record Dates

• First Submitted: December 14, 2022
• First Posted: December 30, 2022
• Study Start: January 1, 2023
• Primary Completion: August 31, 2024
• Study Completion: November 30, 2024
• Last Updated: December 30, 2022

Record last verified: 2022-12

Locations

CN (18)