Remaxol® in Mechanical Jaundice of Non-malignant Origin

Status Completed

Clinical Trial Summary

The purpose of this study is to assess the safety and efficacy of Remaxol (succinate + methionine + inosine + nicotinamide; POLYSAN Ltd., Russia) infusions at dose 400 and 800 ml to treat mechanical jaundice of non-tumor cause during the first week after surgery.

Clinical Trial Description

The study will be performed in in-hospital patients with obstructive jaundice cause by conditions other than tumor (predominantly by cholelithiasis; ICD-10 codes K80 and K83.1). The patients will be screened in the 15 days preceeding the appointed drainage surgery. The treatment will be started in the first 6 hours after the drainage surgery and continue for 7 days.

Following screening, patients who meet the inclusion criteria and have no criteria for exclusion will be randomly assigned into three study groups in the proportion of 1: 1: 1):

Group I: treatment with Remaxol 400 ml IV + Ringer solution 400 ml IV for 7 days.

Group II: treatment with Remaxol 800 ml IV for 7 days. Group III (control): Ringer solution 800 ml IV for 7 days.

Physical examination data, vital signs, biochemistry panel (including bilirubin, alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, GGTP) will be assessed on days 1-8, on day 11 and day 14.

Diagnostic abdominal ultrasound will be performed before surgery and on days 3 and 8.

Neurophysiological test for the evaluation of the degree of encephalopathy will be performed before surgery, on days 3, 5, 8, and 14.

All patients will be followed up for 14 days. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03418935
Study type	Interventional
Source	POLYSAN Scientific & Technological Pharmaceutical Company
Contact
Status	Completed
Phase	Phase 3
Start date	April 3, 2017
Completion date	April 13, 2020

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT00196105` - Malignant Obstruction ZILVER Against Routine Therapy (MOZART I)	N/A
Not yet recruiting	`NCT03252379` - Endoscopic Access Loop With Bilio-enteric Anastomosis: A Prospective Randomized Comparison Between Gastric and Subcutaneous Accesses	N/A
Recruiting	`NCT06115655` - A Single-center, Prospective Cohort Study on the Differentiation of Benign and Malignant Bile Duct Stenosis Based on Bile and Peripheral Blood cfDNA Methylation Profiles
Completed	`NCT02721277` - SMOFlipid to Lessen the Severity of Neonatal Cholestasis	Phase 1/Phase 2
Completed	`NCT03494023` - EUS Evaluation of CBD Diameter in Malignant Obstructive Jaundice
Completed	`NCT01315522` - Covered vs. Uncovered SEMS for Occluded Biliary Metal Stents	Phase 4
Active, not recruiting	`NCT05078801` - Endoscopic Versus Radiologic Biliary Drainage for Perihilar Malignant Obstruction
Recruiting	`NCT06115564` - Microbiological Assessment of Bile in Patients Undergone to Endoscopic Retrograde Cholangiography (ERCP): the "Microbile Registry"
Completed	`NCT04251013` - Multicenter RCT for BIliary Brushing: RX Cytology, BOSTON vs. Infinity®, US Endoscopy	N/A
Recruiting	`NCT06197984` - Antimicrobial Resistance in Acute Cholangitis
Completed	`NCT02477228` - Biliary Cannulation During Endoscopic Retrograde Cholangiopancreatography: Precut Versus Conventional Cannulation	N/A
Completed	`NCT04582240` - Bile Duct Injury Digestif
Not yet recruiting	`NCT06196164` - A RCT of Low MBO Drainage Strategies	N/A
Not yet recruiting	`NCT03527875` - Process Optimization of Preoperative Biliary Drainage in Patients With Malignant Obstructive Jaundice	N/A
Recruiting	`NCT02279147` - Cholinergic Anti-inflammatory Pathway in Prevention & Treatment of the SIRS in Patients With Jaundice After Operation.	Phase 1/Phase 2
Recruiting	`NCT04801238` - preGallstep - A Clinical Pilot Trial	N/A