About this trial
Post-marketing Observational Clinical Study: Assessment of the Effectiveness (Efficacy) of Odeston (Odeston®) in Patients With Chronic Cholecystitis in Real Medical Practice
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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;
Trial population
Patients of both sexes aged ≥18 to 65 years inclusive with a verified diagnosis: chronic acalculous cholecystitis
Trial design
Other
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Dynamics of Visual Analogue Scale scores for the severity and frequency of pain symptoms
Secondary outcomes
Proportion of patients with a decrease in the severity of dyspeptic syndrome based on the Leeds Questionnaire
Dynamics of quality of life indicators based on the Digestive Quality of Life Questionnaire
Incidence of SUSAR
The dynamics of Aspartate aminotransferase
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: