An Assessment of the Effectiveness (Efficacy) of Odeston (Odeston®) in Patients With Chronic Cholecystitis in Real Medical Practice
NCT Number: NCT06516718
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Chronic Cholecystitis
Sponsor: Kazakhstan Scientific Society for Study of intestine diseases
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 169
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08
Completion Date: 2025-08
Locations: "Human Health Clinic" LLP, Almaty, 055990, Kazakhstan|JSC "Research institute of cardiology and internal disease", Almaty, 055990, Kazakhstan|State-owned public enterprise with the right of economic management City Clinic No. 5, Almaty, 055990, Kazakhstan|"Taimas Medical" LLP, Astana, Kazakhstan|Medical center "Aiya", Astana, Kazakhstan|Medical Center Hospital of the President's affairs Administration of the Republic of Kazakhstan, Astana, Kazakhstan|NpJSC "Astana Medical University", Astana, Kazakhstan|State-owned public enterprise with the right of economic management "Multidisciplinary regional hospital" of the Kyzylorda Region Health Department, Kyzylorda, Kazakhstan|"Treatment Center No. 14" LLP, Shymkent, Kazakhstan|City diagnostic center of Shymkent, Shymkent, Kazakhstan|Medical Center "Aesculapius Vita", Shymkent, 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|"Comec Medical Company" Llp, Taraz, Kazakhstan|"Hayat Medical Group" LLP Diagnostic Center, Taraz, Kazakhstan|Medical Center "Meyirim", Taraz, Kazakhstan

Summary:
Post-marketing Observational Clinical Study: Assessment of the Effectiveness (Efficacy) of Odeston (Odeston®) in Patients With Chronic Cholecystitis in Real Medical Practice

Primary Outcome Measures: Dynamics of Visual Analogue Scale scores for the severity and frequency of pain symptoms, on day 21
Secondary Outcome Measures: Proportion of patients with a decrease in the severity of dyspeptic syndrome based on the Leeds Questionnaire, on day 21|Dynamics of quality of life indicators based on the Digestive Quality of Life Questionnaire, on day 21|Incidence of SUSAR, on day 21|The dynamics of Aspartate aminotransferase, on day 21|The dynamics of Alanine aminotransferase, 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|Frequency of use of concomitant therapy, on day 21|Assessment of the shape of the gallbladder by ultrasound, on day 21|Assessment of the size of the gallbladder by ultrasound, on day 21|Assessment of the thickness of the gallbladder walls by ultrasound, on day 21|Assessment of the presence of intraluminal formations of the bladder 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|Assessment of the size of the common bile duct 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