NCT06516718尚未招募不适用
Post-marketing Observational Clinical Study: Assessment of the Effectiveness (Efficacy) of Odeston (Odeston®) in Patients With Chronic Cholecystitis in Real Medical Practice
Kazakhstan Scientific Society for Study of intestine diseases15 个研究点 分布在 1 个国家目标入组 169 人开始时间: 2024年8月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 169
- 试验地点
- 15
- 主要终点
- Dynamics of Visual Analogue Scale scores for the severity and frequency of pain symptoms
研究概览
简要总结
Post-marketing Observational Clinical Study: Assessment of the Effectiveness (Efficacy) of Odeston (Odeston®) in Patients With Chronic Cholecystitis in Real Medical Practice
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women aged 18 to 65 years;
- •BMI 18.5 - 40;
- •Verified diagnosis: chronic acalculous cholecystitis;
- •Voluntary desire to provide informed consent to participate in the study
排除标准
- •Presence of stones in the gall bladder and bile ducts;
- •The presence of jaundice, cholestatic liver diseases, liver cirrhosis with decompensation;
- •Increased ALT, AST above the 3 upper limits of normal;
- •Hypersensitivity to the components of the drug Odeston;
- •Pregnancy and lactation;
- •Prolonged fasting and total parenteral nutrition;
- •Patients with symptoms of acute abdomen at the time of inclusion in the study;
- •Patients with symptoms of acute neurological pathology at the time of inclusion in the study and/or аcute cerebrovascular accident, a history of convulsive syndrome;
- •Presence of cancer;
- •Acute infectious diseases at the time of inclusion in the study;
- •Fever of any origin (above 37.5 C);
- •Patients with symptoms of heart failure;
- •Patients with symptoms of pulmonary failure;
- •Patients with symptoms of acute or chronic renal failure;
- •A decompensated form of diabetes;
- •Patients with signs of psychiatric disorders.
结局指标
主要结局
Dynamics of Visual Analogue Scale scores for the severity and frequency of pain symptoms
时间窗: on day 21
次要结局
- Assessment of the size of the common bile duct by ultrasound(on day 21)
- Assessment of the size of the gallbladder by ultrasound(on day 21)
- Assessment of the presence of an acoustic shadow by ultrasound(on day 21)
- Assessment of the mobility of intraluminal formations by ultrasound(on day 21)
- Assessment of the presence of biliary sludge by ultrasound(on day 21)
- Proportion of patients with a decrease in the severity of dyspeptic syndrome based on the Leeds Questionnaire(on day 21)
- Frequency of use of concomitant therapy(on day 21)
- Assessment of the presence of intraluminal formations of the bladder by ultrasound(on day 21)
- Incidence of SUSAR(on day 21)
- The dynamics of Alkaline phosphatase(on day 21)
- The dynamics of Gamma-glutamyl transpeptidase(on day 21)
- The dynamics of bilirubin with fractions(on day 21)
- Types of concomitant therapy uses(on day 21)
- Assessment of the thickness of the gallbladder walls by ultrasound(on day 21)
- The dynamics of Aspartate aminotransferase(on day 21)
- The dynamics of Alanine aminotransferase(on day 21)
- Assessment of the shape of the gallbladder by ultrasound(on day 21)
- Assessment of the presence of dilatation of the intrahepatic bile ducts by ultrasound(on day 21)
- Assessment of the presence of additional formations using ultrasound(on day 21)
- Dynamics of quality of life indicators based on the Digestive Quality of Life Questionnaire(on day 21)
研究者
研究点 (15)
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