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

Status: Recruiting
Location: See all (9) locations...
Intervention Type: Drug
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• Signed informed consent form.

• Age from 18 to 70 years

• Diagnosis: Gallstone disease. Cholelithiasis, choledocholithiasis. Obstructive jaundice.

• Total bilirubin level in the blood in the range from 102.5 to 246 µmol/l.

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

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

Locations
Other Locations
Russian Federation
Krai Clinical Hospital
RECRUITING
Barnaul
Hospital for War Veterans
RECRUITING
Kazan'
City Clinical Hospital No. 7
RECRUITING
Nizhny Novgorod
Pavlov Ryazan State Medical University
RECRUITING
Ryazan
Dzhanelidze St. Petersburg Research Institute of Emergency Medicine
RECRUITING
Saint Petersburg
St. Elizabeth Hospital
RECRUITING
Saint Petersburg
Samara State Medical University
RECRUITING
Samara
Mirotvortsev University Clinical Hospital No. 1
RECRUITING
Saratov
Kuvatov Republican Clinical Hospital
RECRUITING
Ufa
Contact Information
Primary
Alexey Kovalenko, Doc Biol Sci
science@polysan.ru
+78127108225
Time Frame
Start Date: 2022-12-01
Estimated Completion Date: 2025-12
Participants
Target number of participants: 286
Treatments
The test group
Standard therapy + Remaxol
The control group
Standard therapy
Sponsors
Leads: POLYSAN Scientific & Technological Pharmaceutical Company

This content was sourced from clinicaltrials.gov