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

Launched by POLYSAN SCIENTIFIC & TECHNOLOGICAL PHARMACEUTICAL COMPANY · Jun 28, 2023

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ClinConnect Summary

This clinical trial is studying the use of a medication called Remaxol in patients who have gallstone disease along with a condition called obstructive jaundice, which can cause yellowing of the skin and eyes. The researchers believe that Remaxol may help reduce the length of jaundice and lower the risk of complications during surgery. In this study, they are looking for participants aged 18 to 70 years who have been diagnosed with gallstone disease and have had jaundice for no more than 7 days. Participants should also have specific blood test results indicating their bilirubin levels fall within a certain range.

If you join this trial, you can expect to receive Remaxol during the time leading up to your surgery, which will be performed in two stages: first to relieve any blockage in the bile duct and then to remove the gallbladder. Participants will be closely monitored throughout the process. It’s important to note that certain health conditions, such as severe heart or kidney problems, and being pregnant or breastfeeding, may prevent someone from participating. This study is currently recruiting, so if you think you might be eligible, you can find out more about joining.

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ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Signed informed consent form.
• • 2. Age from 18 to 70 years
• • 3. Diagnosis: Gallstone disease. Cholelithiasis, choledocholithiasis. Obstructive jaundice.
• • 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) laparoscopic cholecystectomy.
• 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.