Multiple Gallbladder PolypsPhase 4PLG001NCT05668871
A Study of Danning Tablet in Patients With Polypoid Lesions of Gallbladder
A Phase 4 study testing Danning Tablet and Lifestyle Management in people with Multiple Gallbladder Polyps, run by Eastern Hepatobiliary Surgery Hospital at 19 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Multiple Gallbladder Polyps
- What is being tested?
- Danning Tablet and Lifestyle Management
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 326 participants
- Where
- 19 sitesChina
- Study dates
- 1 Dec 2022to 25 Feb 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Participants who meet any of the following criteria will not be eligible for inclusion in this study:
- 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.
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- 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.
- Any other situations not suitable for inclusion.
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
China19 sites
Anning First People's Hospital
Anning, Yunan, 0086871
Xiangya Changde Hospital
Changde, Hunan, 0086736
The Sixth People's Hospital of Chengdu
Chengdu, Sichuan, 0086028
Chongqing General Hospital
Chongqing
Ezhou Central Hospital
Ezhou, Hubei
The First Affiliated Hospital of University of South China
Hengyang, Hunan, 0086734
Central Hospital Affiliated to Shandong First Medical University (Jinan Central Hospital)
Jinan, Shandong, 0086531
Jinhua Municipal Central Hospital
Jinhua, Zhejiang, 0086579
Loudi Central Hospital
Loudi, Hunan, 0086738
Ningbo Municipal Hospital of Traditional Chinese Medicine
Ningbo, Zhejiang, 0086574
Eastern Hepatobiliary Surgery Hospital, Naval Medical University,
Shanghai, Shanghai Municipality, 0086021
Shangrao People's Hospital
Shangrao, Jiangxi, 0086793
Affiliated Hospital of Shaoxing University
Shaoxing, Zhejiang, 0086575
Hebei general hospital
Shijiazhuang, Hebei
Shanxi Traditional Chinese Medicine Hospital
Taiyuan, Shanxi
Tangshan Central Hospital
Tangshan, Hebei
Xiantao First People's Hospital
Xiantao, Hubei
Yiwu Central Hospital
Yiwu, Zhejiang
People's Hospital of Yiyang
Yiyang, Hunan, 0086737
About this study
Official title: 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.
Read the 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:
- 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.
- Disease Progression Rate: Assessed by the increase in the size of the largest polyp (≥2 mm in diameter)
- Incidence of Adverse Events/Reactions
- Conditions
- Multiple Gallbladder Polyps
- Being tested
- Danning Tablet, Lifestyle Management
- Keywords
- gallbladder, polyps, healthy lifestyle, herbal medicine, Danning Tablet
- Medical subject headings
- Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Danning TabletDrug
Also called Biliflow
5 tablets per time, 3 times daily, taken orally after meals
Lifestyle ManagementBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Danning Tablet; Behavioral: 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. Receives: Behavioral: Lifestyle Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- 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.
Measured: From enrollment to the end of treatment at 24 weeks
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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
Measured: From enrollment to the end of treatment at 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2022
- Study start1 Dec 2022
- Primary completion25 Feb 2026
- Study completion25 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Gallbladder PolypsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 326 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eastern Hepatobiliary Surgery Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shen Feng, Eastern Hepatobiliary Surgery Hospital
- Investigators
- Feng Shen, MD, PhD, Principal investigator, Eastern Hepatobiliary Surgery Hospital, Naval Medical UniversityTian Yang, MD, PhD, Principal investigator, Eastern Hepatobiliary Surgery Hospital, Naval Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05668871
- Sponsor's protocol ID
- CCPE202201
- Acronym
- PLG001
- Status last verified
- Aug 2026
- First submitted
- 14 Dec 2022
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Danning Tablet Under Lifestyle Intervention in Patients With Polypoid Lesions of Gallbladder: A Randomized, Open-labelled, Multicenter, Controlled Trial
- ClinicalTrials.gov ID
- NCT05668871
- Acronym / sponsor ID
- PLG001 / CCPE202201
- Conditions
- Multiple Gallbladder Polyps
- Keywords
- gallbladder, polyps, healthy lifestyle, herbal medicine, Danning Tablet
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 326 participants (actual)
- Lead sponsor
- Eastern Hepatobiliary Surgery HospitalUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 25 Feb 2026 (actual)
- Study completion
- 25 Feb 2026 (actual)
- First posted
- 30 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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.
- Disease Progression Rate: Assessed by the increase in the size of the largest polyp (≥2 mm in diameter)
- Incidence of Adverse Events/Reactions
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Danning Tablet and lifestyle intervention group | Experimental | Drug: Danning Tablet, Behavioral: Lifestyle Managementreceiving 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. |
| Lifestyle intervention group | Other | Behavioral: Lifestyle Managementlifestyle 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (14 listed)
- Participants who meet any of the following criteria will not be eligible for inclusion in this study:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Danning TabletAlso: Biliflow5 tablets per time, 3 times daily, taken orally after meals | Drug | Danning Tablet and lifestyle intervention group |
| Lifestyle ManagementLifestyle 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. | Behavioural | Danning Tablet and lifestyle intervention group, Lifestyle intervention group |
Primary outcome
Clinical Efficacy Rate
Time frame: From enrollment to the end of treatment at 24 weeks
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.
3 secondary outcomes
Symptom Relief Rate
Time frame: From enrollment to the end of treatment at 24 weeks
Disease Progression Rate
Time frame: From enrollment to the end of treatment at 24 weeks
Incidence of Adverse Events/Reactions
Time frame: From enrollment to the end of treatment at 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Feng Shen, MD, PhD principal investigator
Eastern Hepatobiliary Surgery Hospital, Naval Medical University
Tian Yang, MD, PhD principal investigator
Eastern Hepatobiliary Surgery Hospital, Naval Medical University
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Danning Tablet and Lifestyle Management in people with Multiple Gallbladder Polyps, run by Eastern Hepatobiliary Surgery Hospital at 19 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Efficacy Rate (time frame: From enrollment to the end of treatment at 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026; AzTrials last refreshed its copy on 6 Nov 2026.