Clinical trial NCT05668871: A Study of Danning Tablet in Patients With Polypoid Lesions of Gallbladder
Official title: Effects of Danning Tablet Under Lifestyle Intervention in Patients With Polypoid Lesions of Gallbladder: A Randomized, Open-labelled, Multicenter, Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Polyps Gallbladder
Keywords: gallbladder
polyps
healthy lifestyle
herbal medicine
Danning Tablet
Lead sponsor: Eastern Hepatobiliary Surgery Hospital
Sponsor class: OTHER
First posted: 2022-12-30
Enrollment: 336
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Maximum diameter of gallbladder polyps on weeks 12±1
timeFrame: weeks 12±1
measure: Maximum diameter of gallbladder polyps on weeks 24±1
timeFrame: weeks 24±1
Secondary outcomes:
measure: Thickness of gallbladder wall on weeks 12±1
timeFrame: weeks 12±1
measure: Thickness of gallbladder wall on weeks 24±1
timeFrame: weeks 24±1
measure: Level of abdominal pain on weeks 4±1
timeFrame: weeks 4±1
measure: Level of abdominal pain on weeks 8±1
timeFrame: weeks 8±1
measure: Level of abdominal pain on weeks 12±1
timeFrame: weeks 12±1
measure: Level of abdominal pain on weeks 24±1
timeFrame: weeks 24±1
measure: Clinical safety indexes
timeFrame: up to weeks 24±1
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: The Second Affiliated Hospital of Zhengzhou University
state: Henan
city: Changde
country: China
facility: Xiangya Changde Hospital
state: Hunan
city: Hengyang
country: China
facility: The First Affiliated Hospital of University of South China
state: Hunan
city: Loudi
country: China
facility: Loudi Central Hospital
state: Hunan
city: Yiyang
country: China
facility: Yiyang Central Hospital
state: Hunan
city: Nantong
country: China
facility: Affiliated Hospital of Nantong University
state: Jiangsu
city: Ganzhou
country: China
facility: First Affiliated Hospital of Gannan Medical University
state: Jiangxi
city: Shangrao
country: China
facility: Shangrao People's Hospital
state: Jiangxi
city: Jinan
country: China
facility: Central Hospital Affiliated to Shandong First Medical University (Jinan Central Hospital)
state: Shandong
city: Jinan
country: China
facility: Shandong Provincial Third Hospital
state: Shandong
city: Qingdao
country: China
facility: The Affiliated Hospital of Qingdao University
state: Shandong
city: Shanghai
country: China
facility: Eastern Hepatobiliary Surgery Hospital, Naval Medical University,
state: Shanghai
city: Taiyuan
country: China
facility: Shanxi Provincial People's Hospital
state: Shanxi
city: Chengdu
country: China
facility: The Sixth People's Hospital of Chengdu
state: Sichuan
city: Anning
country: China
facility: Anning First People's Hospital
state: Yunan
city: Jinhua
country: China
facility: Jinhua Municipal Central Hospital
state: Zhejiang
city: Ningbo
country: China
facility: Ningbo Municipal Hospital of Traditional Chinese Medicine
state: Zhejiang
city: Shaoxing
country: China
facility: Affiliated Hospital of Shaoxing University
state: Zhejiang
Study officials:
affiliation: Eastern Hepatobiliary Surgery Hospital, Naval Medical University
name: Feng Shen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Eastern Hepatobiliary Surgery Hospital, Naval Medical University
name: Tian Yang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: