An Assessment of the Effectiveness (Efficacy) of Odeston (Odeston®) in Patients With Chronic Cholecystitis in Real Medical Practice
- Conditions
- Chronic Cholecystitis
- Registration Number
- NCT06516718
- Lead Sponsor
- Kazakhstan Scientific Society for Study of intestine diseases
- Brief Summary
Post-marketing Observational Clinical Study: Assessment of the Effectiveness (Efficacy) of Odeston (Odeston®) in Patients With Chronic Cholecystitis in Real Medical Practice
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 169
- 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
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Dynamics of Visual Analogue Scale scores for the severity and frequency of pain symptoms on day 21
- Secondary Outcome Measures
Name Time Method The dynamics of Aspartate aminotransferase on day 21 The dynamics of Alanine aminotransferase on day 21 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 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
Trial Locations
- Locations (15)
Medical Center Hospital of the President's affairs Administration of the Republic of Kazakhstan
🇰🇿Astana, Kazakhstan
Medical Center "Aesculapius Vita"
🇰🇿Shymkent, Kazakhstan
Medical Center "Meyirim"
🇰🇿Taraz, Kazakhstan
Medical center "Aiya"
🇰🇿Astana, Kazakhstan
"Human Health Clinic" LLP
🇰🇿Almaty, Kazakhstan
State-owned public enterprise with the right of economic management "Multidisciplinary regional hospital" of the Kyzylorda Region Health Department
🇰🇿Kyzylorda, Kazakhstan
NpJSC "Astana Medical University"
🇰🇿Astana, Kazakhstan
"Treatment Center No. 14" LLP
🇰🇿Shymkent, Kazakhstan
"Comec Medical Company" Llp
🇰🇿Taraz, Kazakhstan
JSC "Research institute of cardiology and internal disease"
🇰🇿Almaty, Kazakhstan
City diagnostic center of Shymkent
🇰🇿Shymkent, Kazakhstan
"Hayat Medical Group" LLP Diagnostic Center
🇰🇿Taraz, Kazakhstan
"Taimas Medical" LLP
🇰🇿Astana, Kazakhstan
State-owned public enterprise with the right of economic management City Clinic No. 5
🇰🇿Almaty, Kazakhstan
State-owned public enterprise with the right of economic management "District polyclinic Sauran" of the Department of Public Health of the Turkestan region
🇰🇿Shymkent, Kazakhstan