Using Remaxol to treat gallstone disease with obstructive jaundice
Observational Study of Efficiency of the Drug Remaxol® (Inosine + Meglumine + Methionine + Nicotinamide + Succinic Acid) Used in the Treatment of Patients With Gallstone Disease Complicated With Obstructive Jaundice
This study is testing if a new treatment called Remaxol can help people with gallstone disease and jaundice recover faster and have fewer problems after surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 286 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | POLYSAN Scientific & Technological Pharmaceutical Company Industry-sponsored |
| Locations | 9 sites (Barnaul and 8 other locations) |
| Trial ID | NCT05928286 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the use of Remaxol, a combination of inosine, meglumine, methionine, nicotinamide, and succinic acid, in patients suffering from gallstone disease complicated by obstructive jaundice. The aim is to determine if administering Remaxol during the perioperative period can shorten the duration of jaundice and reduce complications associated with surgical treatment. Patients will undergo a two-staged surgical approach, starting with common bile duct decompression followed by laparoscopic cholecystectomy. The study will include patients aged 18 to 70 with specific bilirubin levels and jaundice duration.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 70 diagnosed with gallstone disease and obstructive jaundice, with specific bilirubin levels and jaundice duration.
Not a fit: Patients with other causes of jaundice, acute infections, or significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could lead to faster recovery and fewer complications for patients with gallstone disease and obstructive jaundice.
How similar studies have performed: While the use of Remaxol in this context is novel, similar approaches in managing jaundice have shown promise in other studies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Barnaul and 8 other locations
- Krai Clinical Hospital — Barnaul, Russian Federation (Recruiting)
- Hospital for War Veterans — Kazan, Russian Federation (Recruiting)
- City Clinical Hospital No. 7 — Nizhny Novgorod, Russian Federation (Recruiting)
- Pavlov Ryazan State Medical University — Ryazan, Russian Federation (Recruiting)
- St. Elizabeth Hospital — Saint Petersburg, Russian Federation (Recruiting)
- Samara State Medical University — Samara, Russian Federation (Recruiting)
- Mirotvortsev University Clinical Hospital No. 1 — Saratov, Russian Federation (Recruiting)
- Dzhanelidze St. Petersburg Research Institute of Emergency Medicine — St. Petersburg, Russian Federation (Recruiting)
- Kuvatov Republican Clinical Hospital — Ufa, Russian Federation (Recruiting)
Study contacts
- Study coordinator: Alexey Kovalenko, Doc Biol Sci
- Email: science@polysan.ru
- Phone: +78127108225
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.