NCT05668871

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
326

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Dec 2022

Typical duration for phase_4

Geographic Reach
1 country

19 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2022

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

December 14, 2022

Completed
16 days until next milestone

First Posted

Study publicly available on registry

December 30, 2022

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 25, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 25, 2026

Completed
Last Updated

August 5, 2026

Status Verified

August 1, 2026

Enrollment Period

3.2 years

First QC Date

December 14, 2022

Last Update Submit

August 3, 2026

Conditions

Multiple Gallbladder Polyps

Keywords

gallbladderpolypshealthy lifestyleherbal medicineDanning Tablet

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Symptom Relief Rate

    From enrollment to the end of treatment at 24 weeks

  • Disease Progression Rate

    From enrollment to the end of treatment at 24 weeks

  • Incidence of Adverse Events/Reactions

    From enrollment to the end of treatment at 24 weeks

Study Arms (2)

Danning Tablet and lifestyle intervention group

EXPERIMENTAL

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 TabletBehavioral: Lifestyle Management

Lifestyle intervention group

OTHER

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

Interventions

Danning TabletDRUG

5 tablets per time, 3 times daily, taken orally after meals

Also known as: Biliflow
Danning Tablet and lifestyle intervention group
Lifestyle ManagementBEHAVIORAL

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.

Danning Tablet and lifestyle intervention groupLifestyle intervention group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants suitable for enrollment in this study must meet all of the following criteria:
  • Adults aged 18-75 years, both male and female.
  • 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.
  • 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.
  • Ability to understand and willingness to sign a written informed consent document.

You may not qualify if:

  • Clinical diagnosis of gallbladder cancer, and/or gallbladder/bile duct stones, and/or acute cholecystitis.
  • Previous gallbladder/biliary tract surgery, such as gallbladder-preserving cholecystolithotomy, lithotomy by endoscopic retrograde cholangiopancreatography (ERCP) or percutaneous transhepatic cholangiography (PTC), etc.
  • Thickness of gallbladder wall \>6 mm based on ultrasound examinations.
  • 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.
  • Irregular stool and/or stool evacuation frequency ≥5 times/day within 2 weeks before enrolment.
  • 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.
  • Currently receiving other pharmacological treatments for MGPs.
  • Regularly taking proton pump inhibitors or H2-receptor antagonists, cholinergic receptor antagonists or gastrin receptor antagonists within 4 weeks before enrolment.
  • Pregnancy or lactation: Women who are pregnant, planning to become pregnant, or breastfeeding.
  • Allergies: Participants with known hypersensitivity to any components of Danning Tablets.
  • Poor patient compliance or being unable to cooperate with the investigator.
  • Participation in another trial within 3 months before enrolment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

Hebei general hospital

Shijiazhuang, Hebei, China

Location

Tangshan Central Hospital

Tangshan, Hebei, China

Location

Ezhou Central Hospital

Ezhou, Hubei, China

Location

Xiantao First People's Hospital

Xiantao, Hubei, 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

People's Hospital of Yiyang

Yiyang, Hunan, 0086737, 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

Eastern Hepatobiliary Surgery Hospital, Naval Medical University,

Shanghai, Shanghai Municipality, 0086021, China

Location

Shanxi Traditional Chinese Medicine Hospital

Taiyuan, Shanxi, 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

Yiwu Central Hospital

Yiwu, Zhejiang, China

Location

Chongqing General Hospital

Chongqing, China

Location

MeSH Terms

Conditions

Polyps

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological 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

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
Model Details: Target population: Patients with multiple gallbladder polyps. Intervention and comparison: 1. 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. 2. Controlled Group: lifestyle intervention alone 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Chief Surgeon

Study Record Dates

First Submitted

December 14, 2022

First Posted

December 30, 2022

Study Start

December 1, 2022

Primary Completion

February 25, 2026

Study Completion

February 25, 2026

Last Updated

August 5, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(19)