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 aim of this study is to evaluate the efficacy and safety of Danning Tablets in the treatment of MGPs. Specifically, the study seeks to determine whether Danning Tablets, when used alongside standard care, can effectively reduce the size of MGPs and improve related symptoms.

Study Overview

• Status: Completed
• Conditions: Multiple Gallbladder Polyps
• Intervention / Treatment: Drug: Danning Tablet; Behavioral: Lifestyle Management

Detailed Description

Study design:

The study will be conducted in phases over a 6-month period, with participants being randomly assigned to either the intervention group (receiving Danning Tablets plus standard care) or the control group (receiving standard care alone). The study will involve multiple follow-up visits for participants at key intervals: baseline (in-person visit), and then follow-ups at the 4th week (telephone), 8th week (telephone), 12th week (in-person), and 24th week (in-person).

Endpoints:

Primary endpoints: Clinical efficacy rate at the 24th week following medication commencement Efficacy is determined based on the proportion of patients who experience a reduction in the size of the largest polyp or complete polyp resolution, as assessed by ultrasound.

Secondary Endpoints:

1. Symptom Relief Rate: This rate evaluates the improvement in symptoms such as abdominal distension, nausea, anorexia, upper right abdominal pain, and radiating right shoulder pain. Improvement is measured using the Visual Analogue Scale (VAS) scores, with a decrease in score indicating symptom relief.
2. Disease Progression Rate: Assessed by the increase in the size of the largest polyp (≥2 mm in diameter)
3. Incidence of Adverse Events/Reactions

• Study Type: Interventional
• Enrollment (Actual): 326
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Chongqing, China
    • Chongqing General Hospital
  • Hebei
    • Shijiazhuang, Hebei, China
      • Hebei General Hospital
    • Tangshan, Hebei, China
      • Tangshan Central Hospital
  • Hubei
    • Ezhou, Hubei, China
      • Ezhou Central Hospital
    • Xiantao, Hubei, China
      • Xiantao First People's Hospital
  • Hunan
    • Changde, Hunan, China, 0086736
      • Xiangya Changde Hospital
    • Hengyang, Hunan, China, 0086734
      • The First Affiliated Hospital of University of South China
    • Loudi, Hunan, China, 0086738
      • Loudi central hospital
    • Yiyang, Hunan, China, 0086737
      • People's Hospital of Yiyang
  • Jiangxi
    • Shangrao, Jiangxi, China, 0086793
      • ShangRao People's Hospital
  • Shandong
    • Jinan, Shandong, China, 0086531
      • Central Hospital Affiliated to Shandong First Medical University (Jinan Central Hospital)
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 0086021
      • Eastern Hepatobiliary Surgery Hospital, Naval Medical University,
  • Shanxi
    • Taiyuan, Shanxi, China
      • Shanxi Traditional Chinese Medicine Hospital
  • Sichuan
    • Chengdu, Sichuan, China, 0086028
      • The Sixth People's Hospital of Chengdu
  • Yunan
    • Anning, Yunan, China, 0086871
      • Anning First People's Hospital
  • Zhejiang
    • Jinhua, Zhejiang, China, 0086579
      • Jinhua municipal central hospital
    • Ningbo, Zhejiang, China, 0086574
      • Ningbo Municipal Hospital of Traditional Chinese Medicine
    • Shaoxing, Zhejiang, China, 0086575
      • Affiliated Hospital of Shaoxing University
    • Yiwu, Zhejiang, China
      • Yiwu Central Hospital

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

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

1. Adults aged 18-75 years, both male and female.
2. Diagnosed with multiple gallbladder polyps (≥2 polyps) based on ultrasound examinations within 2 weeks before enrolment, with largest polyps measuring between 3 mm and 7 mm in diameter.
3. Participants with non-specific or without symptoms related to gallpladder polyps, such as ventosity, nausea, anorexia, right upper abdominal pain, and right shoulder radiating pain, etc.
4. Ability to understand and willingness to sign a written informed consent document.

Exclusion Criteria:

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

1. Clinical diagnosis of gallbladder cancer, and/or gallbladder/bile duct stones, and/or acute cholecystitis.
2. Previous gallbladder/biliary tract surgery, such as gallbladder-preserving cholecystolithotomy, lithotomy by endoscopic retrograde cholangiopancreatography (ERCP) or percutaneous transhepatic cholangiography (PTC), etc.
3. Thickness of gallbladder wall >6 mm based on ultrasound examinations.
4. Severe comorbid conditions, including active severe infectious or severe primary cardiovascular, cerebrovascular, pulmonary, renal, endocrine, or hematopoietic disease, or with mental disorders and/or behavioural abnormalities.
5. Irregular stool and/or stool evacuation frequency ≥5 times/day within 2 weeks before enrolment.
6. Regularly taking any Chinese patent medicine (including TCM injection) with "soothing liver, cholagogic, clearing heat, dredging intestines" clearly written in the instructions, or regularly taking the TCM decoction with the effect of soothing liver and cholagogic within 4 weeks before enrolment.
7. Currently receiving other pharmacological treatments for MGPs.
8. Regularly taking proton pump inhibitors or H2-receptor antagonists, cholinergic receptor antagonists or gastrin receptor antagonists within 4 weeks before enrolment.
9. Pregnancy or lactation: Women who are pregnant, planning to become pregnant, or breastfeeding.
10. Allergies: Participants with known hypersensitivity to any components of Danning Tablets.
11. Poor patient compliance or being unable to cooperate with the investigator.
12. Participation in another trial within 3 months before enrolment.
13. Any 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; receiving Danning Tablets (5 tablets per time, 3 times daily) plus lifestyle intervention from baseline to week 12±1 after randomization, followed by 12-week lifestyle intervention Lifestyle intervention includes dietary advice to avoid cold, spicy, sour, and other irritating foods, abstain from smoking and alcohol, and to avoid excessive fatigue and emotional stress. A regular, low-fat, low-calorie diet is recommended, along with a consistent and timely eating schedule.	Drug: Danning Tablet; 5 tablets per time, 3 times daily, taken orally after meals; Other Names: Biliflow; Behavioral: Lifestyle Management; Lifestyle intervention includes dietary advice to avoid cold, spicy, sour, and other irritating foods,abstain from smoking and alcohol, and to avoid excessive fatigue and emotional stress. Aregular, low-fat, low-calorie diet is recommended, along with a consistent and timely eatingschedule.
Other: Lifestyle intervention group; lifestyle intervention alone from day 1 post randamization to week 24±1 Lifestyle intervention includes dietary advice to avoid cold, spicy, sour, and other irritating foods, abstain from smoking and alcohol, and to avoid excessive fatigue and emotional stress. A regular, low-fat, low-calorie diet is recommended, along with a consistent and timely eating schedule.	Behavioral: Lifestyle Management; Lifestyle intervention includes dietary advice to avoid cold, spicy, sour, and other irritating foods,abstain from smoking and alcohol, and to avoid excessive fatigue and emotional stress. Aregular, low-fat, low-calorie diet is recommended, along with a consistent and timely eatingschedule.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Efficacy Rate	The primary measure is the clinical efficacy rate at the 24th week following medication commencement. Efficacy is determined based on the proportion of patients who experience a reduction in the size of the largest polyp or complete polyp resolution, as assessed by ultrasound. A. Cure: Disappearance of polyps upon re-examination. B. Effective: Reduction in the maximum diameter of the largest polyp. C. Ineffective: No change or increase in the maximum diameter of the largest polyp. Clinical Efficacy Rate: Defined as the proportion of patients who are cured or show effectiveness (Cure+Effective) over the total number of patients.	From enrollment to the end of treatment at 24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Symptom Relief Rate	This rate evaluates the improvement in symptoms such as abdominal distension, nausea, anorexia, upper right abdominal pain, and radiating right shoulder pain. Improvement is measured using the Visual Analogue Scale (VAS) scores, with a decrease in score indicating symptom relief.	From enrollment to the end of treatment at 24 weeks
Disease Progression Rate	The proportion of patients with an increase in the size of the largest polyp (+2 mm in diameter) over the total number of patients.	From enrollment to the end of treatment at 24 weeks
Incidence of Adverse Events/Reactions	Monitoring and reporting of any adverse events or reactions during the trial	From enrollment to the end of treatment at 24 weeks

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 (Actual): December 1, 2022
• Primary Completion (Actual): February 25, 2026
• Study Completion (Actual): February 25, 2026

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): August 5, 2026
• Last Update Submitted That Met QC Criteria: August 3, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

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

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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