An Assessment of the Effectiveness (Efficacy) of Odeston (Odeston®) in Patients With Chronic Chol… (NCT06516718) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
An Assessment of the Effectiveness (Efficacy) of Odeston (Odeston®) in Patients With Chronic Cholecystitis in Real Medical Practice
Kazakhstan169 participantsStarted 2024-08
Plain-language summary
Post-marketing Observational Clinical Study: Assessment of the Effectiveness (Efficacy) of Odeston (Odeston®) in Patients With Chronic Cholecystitis in Real Medical Practice
Who can participate
Age range18 Years – 65 Years
SexALL
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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.
What they're measuring
1
Dynamics of Visual Analogue Scale scores for the severity and frequency of pain symptoms
Timeframe: on day 21
Trial details
NCT IDNCT06516718
SponsorKazakhstan Scientific Society for Study of intestine diseases