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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorKazakhstan Scientific Society for Study of intestine diseases

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 volunteers

Qualifiers

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

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Dynamics of Visual Analogue Scale scores for the severity and frequency of pain symptoms

Time frame
on day 21

Secondary outcomes

1

Proportion of patients with a decrease in the severity of dyspeptic syndrome based on the Leeds Questionnaire

Time frame
on day 21
2

Dynamics of quality of life indicators based on the Digestive Quality of Life Questionnaire

Time frame
on day 21
3

Incidence of SUSAR

Time frame
on day 21
4

The dynamics of Aspartate aminotransferase

Time frame
on day 21

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: