Status:
NOT_YET_RECRUITING
An Assessment of the Effectiveness (Efficacy) of Odeston (Odeston®) in Patients With Chronic Cholecystitis in Real Medical Practice
Lead Sponsor:
Kazakhstan Scientific Society for Study of intestine diseases
Conditions:
Chronic Cholecystitis
Eligibility:
All Genders
18-65 years
Brief Summary
Post-marketing Observational Clinical Study: Assessment of the Effectiveness (Efficacy) of Odeston (Odeston®) in Patients With Chronic Cholecystitis in Real Medical Practice
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 1 2025
Estimated Enrollment :
169 Patients enrolled
Trial Details
Trial ID
NCT06516718
Start Date
August 1 2024
End Date
August 1 2025
Last Update
July 24 2024
Active Locations (15)
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1
"Human Health Clinic" LLP
Almaty, Kazakhstan, 055990
2
JSC "Research institute of cardiology and internal disease"
Almaty, Kazakhstan, 055990
3
State-owned public enterprise with the right of economic management City Clinic No. 5
Almaty, Kazakhstan, 055990
4
"Taimas Medical" LLP
Astana, Kazakhstan