An Assessment of the Effectiveness (Efficacy) of Odeston (Odeston®) in Patients With Chronic Cholecystitis in Real Medical Practice

Launched by KAZAKHSTAN SCIENTIFIC SOCIETY FOR STUDY OF INTESTINE DISEASES · Jul 17, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness of a medication called Odeston in treating chronic cholecystitis, which is a long-term inflammation of the gallbladder that can cause discomfort and digestive issues. The research is designed to see how well Odeston works in real-life medical settings. The trial is currently not recruiting participants, but when it begins, it will focus on adults aged 18 to 65 who have been diagnosed with chronic acalculous cholecystitis, meaning they do not have gallstones.

To participate, individuals must meet certain criteria, such as having a body mass index (BMI) between 18.5 and 40 and being willing to provide consent to join the study. However, those with specific health issues, like gallstones, liver problems, or certain acute conditions, will not be eligible. Participants can expect to take Odeston and be monitored for its effects on their condition. This study aims to gather important information about how well this medication can help manage chronic cholecystitis in everyday medical practice.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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
• Exclusion Criteria:
• • 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.