Effects of Danning Tablet Under Lifestyle Intervention in Patients With Polypoid Lesions of Gallbladder: A Randomized, Open-labelled, Multicenter, Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 326
- 试验地点
- 34
- 主要终点
- Maximum diameter of gallbladder polyps on weeks 12±1
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Open-labelled clinical trial, no masking involved.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
- •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.
研究组 & 干预措施
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.
干预措施: Danning Tablet (Drug)
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.
干预措施: Lifestyle Management (Behavioral)
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.
干预措施: Lifestyle Management (Behavioral)
结局指标
主要结局
Maximum diameter of gallbladder polyps on weeks 12±1
时间窗: weeks 12±1
Use gallbladder ultrasonography to evaluate the maximum diameter of gallbladder polyps.
Maximum diameter of gallbladder polyps on weeks 24±1
时间窗: weeks 24±1
Use gallbladder ultrasonography to evaluate the maximum diameter of gallbladder polyps.
Clinical Efficacy Rate
时间窗: 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.
次要结局
- Thickness of gallbladder wall on weeks 24±1(weeks 24±1)
- Level of abdominal pain on weeks 12±1(weeks 12±1)
- Level of abdominal pain on weeks 24±1(weeks 24±1)
- Level of abdominal pain on weeks 4±1(weeks 4±1)
- Thickness of gallbladder wall on weeks 12±1(weeks 12±1)
- Level of abdominal pain on weeks 8±1(weeks 8±1)
- Clinical safety indexes(up to weeks 24±1)
- Disease Progression Rate(From enrollment to the end of treatment at 24 weeks)
- Symptom Relief 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)
研究者
Shen Feng
Professor and Chief Surgeon
Eastern Hepatobiliary Surgery Hospital