Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06516718

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

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

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

"Human Health Clinic" LLP, Almaty, Kazakhstan

Loading trial locations.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

  5. The dynamics of Alanine aminotransferase

    Time frame: on day 21

  6. The dynamics of Alkaline phosphatase

    Time frame: on day 21

  7. The dynamics of Gamma-glutamyl transpeptidase

    Time frame: on day 21

  8. The dynamics of bilirubin with fractions

    Time frame: on day 21

  9. Types of concomitant therapy uses

    Time frame: on day 21

  10. Frequency of use of concomitant therapy

    Time frame: on day 21

  11. Assessment of the shape of the gallbladder by ultrasound

    Time frame: on day 21

  12. Assessment of the size of the gallbladder by ultrasound

    Time frame: on day 21

  13. Assessment of the thickness of the gallbladder walls by ultrasound

    Time frame: on day 21

  14. Assessment of the presence of intraluminal formations of the bladder by ultrasound

    Time frame: on day 21

  15. Assessment of the presence of an acoustic shadow by ultrasound

    Time frame: on day 21

  16. Assessment of the mobility of intraluminal formations by ultrasound

    Time frame: on day 21

  17. Assessment of the presence of biliary sludge by ultrasound

    Time frame: on day 21

  18. Assessment of the size of the common bile duct by ultrasound

    Time frame: on day 21

  19. Assessment of the presence of dilatation of the intrahepatic bile ducts by ultrasound

    Time frame: on day 21

  20. Assessment of the presence of additional formations using ultrasound

    Time frame: on day 21

Study contacts

Contact information is provided by the study sponsor or research team.

Kanat Khazhidinov

CONTACT

[email protected]

+7 707 413 8263

Yekaterina Sakhabutdinova

CONTACT

[email protected]

+7 707 375 8530

Sponsors and collaborators

Lead sponsor

Kazakhstan Scientific Society for Study of intestine diseases

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 24, 2024
Registry last updated
Jul 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.