Clinical trial NCT06516718: An Assessment of the Effectiveness (Efficacy) of Odeston (Odeston®) in Patients With Chronic Cholecystitis in Real Medical Practice
Official title: Post-marketing Observational Clinical Study: Assessment of the Effectiveness (Efficacy) of Odeston (Odeston®) in Patients With Chronic Cholecystitis in Real Medical Practice
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Chronic Cholecystitis
Lead sponsor: Kazakhstan Scientific Society for Study of intestine diseases
Sponsor class: OTHER
First posted: 2024-07-24
Enrollment: 169
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients of both sexes aged ≥18 to 65 years inclusive with a verified diagnosis: chronic acalculous cholecystitis

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 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.

Primary outcomes:
measure: Dynamics of Visual Analogue Scale scores for the severity and frequency of pain symptoms
timeFrame: on day 21
Secondary outcomes:
measure: Proportion of patients with a decrease in the severity of dyspeptic syndrome based on the Leeds Questionnaire
timeFrame: on day 21
measure: Dynamics of quality of life indicators based on the Digestive Quality of Life Questionnaire
timeFrame: on day 21
measure: Incidence of SUSAR
timeFrame: on day 21
measure: The dynamics of Aspartate aminotransferase
timeFrame: on day 21
measure: The dynamics of Alanine aminotransferase
timeFrame: on day 21
measure: The dynamics of Alkaline phosphatase
timeFrame: on day 21
measure: The dynamics of Gamma-glutamyl transpeptidase
timeFrame: on day 21
measure: The dynamics of bilirubin with fractions
timeFrame: on day 21
measure: Types of concomitant therapy uses
timeFrame: on day 21
measure: Frequency of use of concomitant therapy
timeFrame: on day 21
measure: Assessment of the shape of the gallbladder by ultrasound
timeFrame: on day 21
measure: Assessment of the size of the gallbladder by ultrasound
timeFrame: on day 21
measure: Assessment of the thickness of the gallbladder walls by ultrasound
timeFrame: on day 21
measure: Assessment of the presence of intraluminal formations of the bladder by ultrasound
timeFrame: on day 21
measure: Assessment of the presence of an acoustic shadow by ultrasound
timeFrame: on day 21
measure: Assessment of the mobility of intraluminal formations by ultrasound
timeFrame: on day 21
measure: Assessment of the presence of biliary sludge by ultrasound
timeFrame: on day 21
measure: Assessment of the size of the common bile duct by ultrasound
timeFrame: on day 21
measure: Assessment of the presence of dilatation of the intrahepatic bile ducts by ultrasound
timeFrame: on day 21
measure: Assessment of the presence of additional formations using ultrasound
timeFrame: on day 21
Other outcomes:
Locations:
city: Almaty
country: Kazakhstan
facility: "Human Health Clinic" LLP
city: Almaty
country: Kazakhstan
facility: JSC "Research institute of cardiology and internal disease"
city: Almaty
country: Kazakhstan
facility: State-owned public enterprise with the right of economic management City Clinic No. 5
city: Astana
country: Kazakhstan
facility: "Taimas Medical" LLP
city: Astana
country: Kazakhstan
facility: Medical center "Aiya"
city: Astana
country: Kazakhstan
facility: Medical Center Hospital of the President's affairs Administration of the Republic of Kazakhstan
city: Astana
country: Kazakhstan
facility: NpJSC "Astana Medical University"
city: Kyzylorda
country: Kazakhstan
facility: State-owned public enterprise with the right of economic management "Multidisciplinary regional hospital" of the Kyzylorda Region Health Department
city: Shymkent
country: Kazakhstan
facility: "Treatment Center No. 14" LLP
city: Shymkent
country: Kazakhstan
facility: City diagnostic center of Shymkent
city: Shymkent
country: Kazakhstan
facility: Medical Center "Aesculapius Vita"
city: Shymkent
country: Kazakhstan
facility: State-owned public enterprise with the right of economic management "District polyclinic Sauran" of the Department of Public Health of the Turkestan region
city: Taraz
country: Kazakhstan
facility: "Comec Medical Company" Llp
city: Taraz
country: Kazakhstan
facility: "Hayat Medical Group" LLP Diagnostic Center
city: Taraz
country: Kazakhstan
facility: Medical Center "Meyirim"
Study officials:
References: