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Chronic CholecystitisNCT06516718

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

An observational study of Chronic Cholecystitis, run by Kazakhstan Scientific Society for Study of intestine diseases at 15 sites in Kazakhstan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Chronic Cholecystitis
How many people
169 participants
Where
15 sitesKazakhstan
Study dates
Aug 2024to Aug 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Adult, Older adult

Study population: Patients of both sexes aged ≥18 to 65 years inclusive with a verified diagnosis: chronic acalculous cholecystitis

Who may be able to join

  • 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

Who cannot join

  • 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;
Show all 16Show fewer
  • 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 locations and contacts

15 sites in 1 country.

Kanat Khazhidinov contact

+7 707 413 8263

kanat.khazhidinov@smo-mera.kz

Yekaterina Sakhabutdinova contact

+7 707 375 8530

yekaterina.sakhabutdinova@smo-mera.kz

15 sites in 1 country

Kazakhstan15 sites

  • "Human Health Clinic" LLP

    Almaty, 055990

    Sultan Z.K., +7 (727) 292-51-51, zashenova75@mail.ru

  • JSC "Research institute of cardiology and internal disease"

    Almaty, 055990

    Marat Pashimov, +7(727)233-00-23, priem-dir@ncvb.kz

  • State-owned public enterprise with the right of economic management City Clinic No. 5

    Almaty, 055990

    Kambarova G.A., 8 (727) 233-39-62, gkkp5@inbox.ru

  • "Taimas Medical" LLP

    Astana

    Khutiev S.Ya., +7(777)017-10-07, beisenbayev_e@mail.ru

  • Medical center "Aiya"

    Astana

    Otepova G.D., +7(7172) 36 02 49, ole_olya2019@mail.ru

  • Medical Center Hospital of the President's affairs Administration of the Republic of Kazakhstan

    Astana

    Albaev R.K., +7 (7172) 70-80-90, bmcudpportal@bmc.mcudp.kz

  • NpJSC "Astana Medical University"

    Astana

    Nadyrov K.T., +77001539447, rektorat@amu.kz

  • State-owned public enterprise with the right of economic management "Multidisciplinary regional hospital" of the Kyzylorda Region Health Department

    Kyzylorda

    Baimakhanov Zh.B., +7 (7242)23-51-50

  • "Treatment Center No. 14" LLP

    Shymkent

    Aitbaev D.S., +77052830192

  • City diagnostic center of Shymkent

    Shymkent

    Myrzakhmetova Sh.I., +7 (7252) 99-78-78, info@diagnostik.kz

  • Medical Center "Aesculapius Vita"

    Shymkent

    Svanova Zh.B., +7 (7252) 57 35 61, eskulap_vita@mail.ru

  • State-owned public enterprise with the right of economic management "District polyclinic Sauran" of the Department of Public Health of the Turkestan region

    Shymkent

    Stamkulov B.E., 8(72533) 46703, rps0609@mail.ru

  • "Comec Medical Company" Llp

    Taraz

    Pogrebovsky V.M., +77018794800

  • "Hayat Medical Group" LLP Diagnostic Center

    Taraz

    Mamedov, +77018794800

  • Medical Center "Meyirim"

    Taraz

    Maidanov O.K., +7(7262) 55 67 55

Other trials in Kazakhstan

About this study

Official title: Post-marketing Observational Clinical Study: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: on day 21

Secondary outcomes (20)

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

    Measured: on day 21

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

    Measured: on day 21

  3. Incidence of SUSAR

    Measured: on day 21

  4. The dynamics of Aspartate aminotransferase

    Measured: on day 21

  5. The dynamics of Alanine aminotransferase

    Measured: on day 21

  6. The dynamics of Alkaline phosphatase

    Measured: on day 21

  7. The dynamics of Gamma-glutamyl transpeptidase

    Measured: on day 21

  8. The dynamics of bilirubin with fractions

    Measured: on day 21

  9. Types of concomitant therapy uses

    Measured: on day 21

  10. Frequency of use of concomitant therapy

    Measured: on day 21

  11. Assessment of the shape of the gallbladder by ultrasound

    Measured: on day 21

  12. Assessment of the size of the gallbladder by ultrasound

    Measured: on day 21

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

    Measured: on day 21

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

    Measured: on day 21

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

    Measured: on day 21

  16. Assessment of the mobility of intraluminal formations by ultrasound

    Measured: on day 21

  17. Assessment of the presence of biliary sludge by ultrasound

    Measured: on day 21

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

    Measured: on day 21

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

    Measured: on day 21

  20. Assessment of the presence of additional formations using ultrasound

    Measured: on day 21

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jul 2024
  2. Study startAug 2024 (estimated)
  3. Primary completionAug 2025 (estimated)
  4. Study completionAug 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
169 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06516718
Sponsor's protocol ID
UO-KSSSID-01
Status last verified
Jul 2024
First submitted
9 Jul 2024
Last updated
24 Jul 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Cholecystitis, run by Kazakhstan Scientific Society for Study of intestine diseases at 15 sites in Kazakhstan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 24 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in Kazakhstan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Kanat Khazhidinov (+7 707 413 8263, kanat.khazhidinov@smo-mera.kz), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dynamics of Visual Analogue Scale scores for the severity and frequency of pain symptoms (time frame: on day 21). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06516718.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2024.

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