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

K

Kazakhstan Scientific Society for Study of intestine diseases

Status

Not yet enrolling

Conditions

Chronic Cholecystitis

Study type

Observational

Funder types

Other

Identifiers

NCT06516718
UO-KSSSID-01

Details and patient eligibility

About

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

Enrollment

169 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.

Trial contacts and locations

15

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Central trial contact

Kanat Khazhidinov; Yekaterina Sakhabutdinova

Data sourced from clinicaltrials.gov

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