Remaxol® Used in the Treatment of Patients With Gallstone Disease Complicated With Obstructive Jaundice

Last updated: April 17, 2026
Sponsor: POLYSAN Scientific & Technological Pharmaceutical Company
Overall Status: Completed

Phase

N/A

Condition

Liver Disorders

Liver Disease

Gall Bladder Disorders

Treatment

Remaxol

Clinical Study ID

NCT05928286
Remaxol\2022\02
  • Ages 18-70
  • All Genders

Study Summary

Obstructive jaundice is observed in 10-80 % of gallstone disease cases. The conventional tactics for the management of patients with obstructive jaundice is to remove biliary hypertension by using endoscopic or minimally invasive methods. The final surgical treatment is performed after jaundice reduction and normalization of hepatic functions. We suppose that the administration of the drug Remaxol (Inosine + Meglumine + Methionine

  • Nicotinamide + Succinic acid) during the perioperative period shortens jaundice duration and decreases the complications rate.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Signed informed consent form.

  2. Age from 18 to 80 years

  3. Diagnosis: Gallstone disease. Cholelithiasis, choledocholithiasis. Obstructivejaundice.

  4. Total bilirubin level in the blood in the range from 60 to 246 µmol/l.

  5. Jaundice duration according to the patient is not more than 7 days.

  6. Scheduled two-staged surgical treatment: 1) common bile duct decompression (endoscopic papillosphincterotomy and endoscopic lithoextraction); 2) laparoscopiccholecystectomy.

Exclusion

Exclusion Criteria:

  1. Presence of other pathology causing jaundice syndrome (tumors, constrictions, etc.).

  2. Acute cholangitis. Acute cholecystitis. Acute pancreatitis.

  3. History of chronic viral hepatitis, hepatic cirrhosis.

  4. Other surgical pathology aggravating the condition and/or requiring treatment.

  5. Use in the treatment of drugs containing ademethionine.

  6. CHF, functional class III-IV according to NYHA.

  7. History of chronic kidney disease and/or creatinine level of more than 130 µmol/l.

  8. Respiratory failure.

  9. Impairment of consciousness.

  10. Diabetes mellitus.

  11. Psychic diseases.

  12. Autoimmune diseases.

  13. Tuberculosis, HIV infection.

  14. Pregnancy, lactation.

Study Design

Total Participants: 286
Treatment Group(s): 1
Primary Treatment: Remaxol
Phase:
Study Start date:
December 01, 2022
Estimated Completion Date:
December 31, 2025

Connect with a study center

  • Krai Clinical Hospital

    Barnaul,
    Russia

    Site Not Available

  • Hospital for War Veterans

    Kazan',
    Russia

    Site Not Available

  • City Clinical Hospital No. 7

    Nizhny Novgorod,
    Russia

    Site Not Available

  • Pavlov Ryazan State Medical University

    Ryazan,
    Russia

    Site Not Available

  • Dzhanelidze St. Petersburg Research Institute of Emergency Medicine

    Saint Petersburg,
    Russia

    Site Not Available

  • St. Elizabeth Hospital

    Saint Petersburg,
    Russia

    Site Not Available

  • Samara State Medical University

    Samara,
    Russia

    Site Not Available

  • Mirotvortsev University Clinical Hospital No. 1

    Saratov,
    Russia

    Site Not Available

  • Kuvatov Republican Clinical Hospital

    Ufa,
    Russia

    Site Not Available

  • Krai Clinical Hospital

    Barnaul,
    Russian Federation

    Active - Recruiting

  • Hospital for War Veterans

    Kazan,
    Russian Federation

    Site Not Available

  • City Clinical Hospital No. 7

    Nizhny Novgorod,
    Russian Federation

    Active - Recruiting

  • Pavlov Ryazan State Medical University

    Ryazan,
    Russian Federation

    Active - Recruiting

  • St. Elizabeth Hospital

    Saint Petersburg,
    Russian Federation

    Active - Recruiting

  • Samara State Medical University

    Samara,
    Russian Federation

    Active - Recruiting

  • Mirotvortsev University Clinical Hospital No. 1

    Saratov,
    Russian Federation

    Active - Recruiting

  • Dzhanelidze St. Petersburg Research Institute of Emergency Medicine

    St. Petersburg,
    Russian Federation

    Site Not Available

  • Kuvatov Republican Clinical Hospital

    Ufa,
    Russian Federation

    Active - Recruiting

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.