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New drug may shorten jaundice in gallstone patients

NCT ID NCT05928286

Disease control Sponsor: POLYSAN Scientific & Technological Pharmaceutical Company Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at whether a drug called Remaxol can help people with gallstones and a serious complication called obstructive jaundice. Obstructive jaundice happens when a gallstone blocks the bile duct, causing yellowing of the skin and eyes. The study involved 286 adults who were scheduled for two surgeries to remove the blockage and then the gallbladder. Researchers wanted to see if giving Remaxol around the time of surgery could shorten the jaundice and lower the risk of complications.

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Study facts

What this study's own registry entry says, in plain language.

Participants

286 people

The number who actually took part.

Started

Dec 2022

Finished

Dec 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients with gallstone disease and obstructive jaundice, hospitalized for surgical treatment.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Signed informed consent form. 2. Age from 18 to 80 years 3. Diagnosis: Gallstone disease. Cholelithiasis, choledocholithiasis. Obstructive jaundice. 4. Total bilirubin level in the blood in the range from 60 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.

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Conditions

The condition(s) this trial relates to.

cholelithiasis gallstones obstructive jaundice

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Gallstone disease Obstructive jaundice

Contacts and locations

Locations

  • City Clinical Hospital No. 7

    Nizhny Novgorod, Russia

  • Dzhanelidze St. Petersburg Research Institute of Emergency Medicine

    Saint Petersburg, Russia

  • Hospital for War Veterans

    Kazan', Russia

  • Krai Clinical Hospital

    Barnaul, Russia

  • Kuvatov Republican Clinical Hospital

    Ufa, Russia

  • Mirotvortsev University Clinical Hospital No. 1

    Saratov, Russia

  • Pavlov Ryazan State Medical University

    Ryazan, Russia

  • Samara State Medical University

    Samara, Russia

  • St. Elizabeth Hospital

    Saint Petersburg, Russia

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