Runihol in Nonalcoholic Fatty Liver Disease and Metabolic Syndrome

Summary

The study is designed to assess the safety and efficacy of different doses and dosing regimens of Runihol, tablets, enteric coated, produced by "NTFF" POLYSAN" (Russia), in prevention of liver disease progression in patients with non-alcoholic fatty liver disease and metabolic syndrome.

Conditions

• Non-alcoholic Fatty Liver Disease

Interventions

DRUG

Runihol

Composition of Runihol®: One tablet contains: Active ingredients: succinic acid - 0.250 g; Riboxinum (inosine) - 0.100 g; taurine - 0.050 g; Methionine - 0.050 g Excipients - 0.184 g: potato starch, povidone, microcrystalline cellulose, calcium stearate, hypromellose, polysorbate-80. Enteric coat - 0.061 g: methacrylic acid-ethyl acrylate copolymer, talc, titanium dioxide, triethyl citrate, colloidal silicon dioxide, sodium hydrogencarbonate, sodium lauryl sulfate.

OTHER

Placebo

The composition of the drug in one tablet: Active substance: None. The tablet core - 0.634 g: potato starch, povidone, microcrystalline cellulose, calcium stearate, hypromellose, polysorbate-80. Enteric coat - 0.061 g: methacrylic acid-ethyl acrylate copolymer, talc, titanium dioxide, triethyl citrate, colloidal silicon dioxide, sodium hydrogencarbonate, sodium lauryl sulfate. Tablet weight enteric coated - 0.695 g

Sponsors & Collaborators

• POLYSAN Scientific & Technological Pharmaceutical Company

  lead INDUSTRY

Principal Investigators

• Igor G Nikitin · Central Clinical Hospital of the Russian Academy of Sciences

• Vladimir B Grinevich · Military Medical Academy named after SM Kirov," the Russian Defense Ministry, 2nd Department and Clinic of medical postrgaduate education

• Alexander V Gordienko · Military Medical Academy named after SM Kirov," the Russian Ministry of Defense, Hospital Therapeutic Department and Clinic

• Vyacheslav G Morozov · Medical company "Hepatologist" Ltd.

• Vladimir V Gorbakov · Company "Clinic of professor Gorbakov" Ltd.

• Chavdar S Pavlov · First Moscow State Medical University named after IM Sechenov, Russian Federation Ministry of Public Health, University Clinical Hospital №2,

• Michael A Osadchuk · First Moscow State Medical University named after IM Sechenov, Health Ministry of the Russian Federation, Outpatient Department

• Andrew Yu Baranovsky · St. Petersburg State health care institution "City Clinical Hospital №31"

• Lyudmila S Oreshko · Federal State Educational Institution of Higher Education "Northwest State Medical University named after II Mechnikov," the Ministry of Health and Social Development of the Russian Federation

• Viktor D Pasechnikov · Stavropol State Medical University, Ministry of Health of the Russian Federation, Department of therapy with a course of dietetics

• Maria A Livzan · Omsk State Medical Academy, Ministry of Health and Social Development of the Russian Federation, Department of faculty therapy

• Yuri P Uspenskiy · St. Petersburg City Hospital of the Holy Martyr Elizabeth

• David L Nepomnyashchikh · State Novosibirsk Regional Clinical Hospital

• Polina M Hlyabova · Limited Liability Company "BioEk" Ltd.

• Sergei L Grishaev · St. Petersburg state healthcare institution "Mariinsky Outpatient Clinic"

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-05-30

Primary Completion

2018-10-10

Completion

2018-10-10

Countries

• Russia

Study Locations