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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

169 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-08-31

Study Completion Date

2025-08-31

Brief Summary

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

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Detailed Description

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Conditions

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Chronic Cholecystitis

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No