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

Last updated: December 11, 2024
Sponsor: POLYSAN Scientific & Technological Pharmaceutical Company
Overall Status: Active - Recruiting

Phase

N/A

Condition

Gall Bladder Disorders

Liver Disorders

Primary Biliary Cholangitis

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 70 years

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

  4. Total bilirubin level in the blood in the range from 102.5 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,
    Russian Federation

    Active - Recruiting

  • Hospital for War Veterans

    Kazan,
    Russian Federation

    Active - Recruiting

  • 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

    Active - Recruiting

  • Kuvatov Republican Clinical Hospital

    Ufa,
    Russian Federation

    Active - Recruiting

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