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Trial record 32 of 49 for:    Sodium Lauryl Sulfate

Runihol in Nonalcoholic Fatty Liver Disease and Metabolic Syndrome

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ClinicalTrials.gov Identifier: NCT02930161
Recruitment Status : Terminated (Low recruitment)
First Posted : October 12, 2016
Last Update Posted : February 8, 2019
Sponsor:
Information provided by (Responsible Party):
POLYSAN Scientific & Technological Pharmaceutical Company

Brief 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.

Condition or disease Intervention/treatment Phase
Non-alcoholic Fatty Liver Disease Drug: Runihol Other: Placebo Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Многоцентровое двойное слепое плацебо-контролируемое рандомизированное исследование препарата Рунихол® у пациентов с неалкогольной жировой болезнью печени на фоне метаболического синдрома
Actual Study Start Date : May 30, 2016
Actual Primary Completion Date : October 10, 2018
Actual Study Completion Date : October 10, 2018


Arm Intervention/treatment
Experimental: Runihol 2 tablets x 2 times a day
Intake of 1 tablet of Runihol and 1 placebo tablet orally, with drinking 100 ml of water, 30 minutes before meals three times a day (morning, afternoon and evening) for 84 days (12 weeks).
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 Name: Runihol, coated pill, produced by POLYSAN Ltd (Russia)

Experimental: Runihol 1 tablet x 3 times a day
Intake of Runihol, 2 tablets orally, with drinking 100 ml of water, 30 minutes before meals, 2 times a day (morning and evening) for 84 days (12 weeks), and 2 placebo tablets orally, with drinking 100 ml of water, 30 minutes before meals, 1 time a day (afternoon) for 84 days (12 weeks).
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 Name: Runihol, coated pill, produced by POLYSAN Ltd (Russia)

Placebo Comparator: Placebo
Two placebo tablets orally, with drinking 100 ml of water, 30 minutes before meals three times a day (morning, afternoon and evening) for 84 days (12 weeks).
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





Primary Outcome Measures :
  1. Proportion of responders to treatment [ Time Frame: 102 days, including the screening period (14 days) ]
    The proportion of responders with non-alcoholic fatty liver disease, as demonstrated by assessment of liver function by the following laboratory findings: decrease in ALT and AST iby at least 40% from baseline, and / or reduction of GGT by at least 30% from baseline at the end of the course of treatment


Secondary Outcome Measures :
  1. Severity of dyslipidemia [ Time Frame: 102 days, including the screening period (14 days) ]
    The dynamics of the severity of atherogenic dyslipidemia (as demonstrated by the level of total cholesterol, triglycerides, cholesterol, low density lipoprotein (LDL), high density lipoprotein cholesterol (HDL-C)) in patients by the end of the therapeutic course in comparison with baseline findings

  2. The insulin resistance index (HOMA-IR) [ Time Frame: 102 days, including the screening period (14 days) ]
    The change of the insulin resistance index (index HOMA-IR, calculated according to the level of fasting plasma glucose, fasting insulin) in patients by the end of the treatment course in comparison with the baseline findings

  3. Transaminases [ Time Frame: 102 days ]
    Dynamics of transaminases serum levels (ALT, AST) in patients between the study visits

  4. cholestasis markers (alkaline phosphatase, GGT) [ Time Frame: 102 days ]
    Dynamics of cholestasis markers (alkaline phosphatase, GGT) in the serum of patients between study visits

  5. Bilirubin [ Time Frame: 102 days ]
    Dynamics of total bilirubin serum levels (ALT, AST) in patients between the study visits

  6. Body mass index [ Time Frame: 102 days ]
    Change of the BMI of patients at the end of the treatment course in comparison with the baseline measurements

  7. ultrasound signs of hepatic steatosis [ Time Frame: 102 days ]
    Dynamics of ultrasound signs of hepatic steatosis in patients by the end of the treatment course in comparison with the baseline


Other Outcome Measures:
  1. Serum homocysteine [ Time Frame: 102 days ]
    homocysteine serum level at screening and at all study visits



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. A signed informed consent to participate in the study.
  2. Men and women aged 18 to 65 years.
  3. Diagnosis: non-alcoholic fatty liver disease (code ICD-10: K76.0 Fatty degeneration of the liver, not classified elsewhere), defined as non-alcoholic steatohepatitis.
  4. Metabolic syndrome (according to the national criteria accepted in 2013).
  5. The body mass index (BMI) of 30-45 kg / m2.
  6. The presence of signs of steatosis on ultrasound examination of the liver (distal signal attenuation and / or increased echogenicity of the liver).
  7. The level of total cholesterol> 6.0 mmol/l and / or triglyceride levels> 1.7 mmol/l.
  8. ALT, AST serum levels exceed upper normal limits by 1,5-7 times.
  9. GGT level higher that upper normal limit by 1,5-7 times.
  10. The level of SBP>140 and / or DBP> 90 mm Hg or antihypertensive therapy required to maintain normal blood pressure values.
  11. A negativepregnancy test for female participants.
  12. Consent to use of appropriate methods of contraception ( with contraceptive reliability over 90%: the cervical cap with spermicide, diaphragm with spermicide, condoms, intrauterine devices), or abstaining from sexual activity for the study period.
  13. Consent to limit alcohol consumption to a maximum of 2 units of alcohol per month (1 unit of alcohol is equivalent to 0.5 liters of beer, 200 ml of dry wine or 50 ml of spirits), or total abstaining from alcohol consumption for the study period.

Exclusion Criteria:

  1. Chronic liver disease of any other aetiology.
  2. Disorders of copper metabolism, and/or ceruloplasmin serum level beyond the reference value on screening.
  3. Disorders of iron metabolism in the past medical history or revealed at screening.
  4. Cirrhotic stage of nonalcoholic fatty liver disease (Class A-C by Child-Pugh).
  5. Type I diabetes mellitus.
  6. Type II diabetes mellitus, which requires regular oral hypoglycemic therapy or insulin, or the level of fasting plasma glucose> 7 mmol / l and / or glycosylated hemoglobin> 7% on screening.
  7. Any severely decompensated somatic disease
  8. Regular intake of the medications that are prohibited by the study protocol, or their intake within 4 weeks prior to inclusion.
  9. The history of clinically significant allergic reactions.
  10. Hypersensitivity to any component of the study drug and / or intolerance to any component of the study drug.
  11. Bariatric surgery in less than 6 months prior to the study.
  12. Pregnancy or lactation.
  13. Hyperhomocysteinemia (homocysteine serum levels >15 mmol/dL for men, >12 mmol/dL for women).
  14. Exacerbation of the stomach ulcer and / or duodenal ulcers and / or erosive gastritis.
  15. Chronic kidney failure (stage C4-C5) and / or glomerular filtration rate <30 ml / min on screening.
  16. Gout, with the need of drugs that reduce uric acid levels
  17. Any of the following parameters: Hb <80 g / L, platelets <80 x 10 9 / L, WBC> 15 x 10 9 / L at screening.
  18. Regular intake of more than 5 units of alcohol per week (1 unit of alcohol is equivalent to 0.5 liters of beer, 200 ml of dry wine or 50 ml of spirits) or history of alcohol addiction.
  19. A significant (over 5 kg) weight loss or weight gain during the preceding 6 months prior to the study.
  20. Unstable angina pectoris.
  21. Myocardial infarction within 3 months before inclusion.
  22. Chronic heart failure (III-IV functional class by NYHA).
  23. A history of cancer, mental illness, HIV, tuberculosis, or drug addiction.
  24. Mental, physical and other reasons that do not allow the patient to comply with the study procedures.
  25. Any other condition which, according to the investigator's judgement, may interfere with the compliance to study procedures.
  26. Participation in any other clinical trial within 3 months prior to the inclusion.
  27. Employees of the research company or study site involved in the conduct of the present study, and their family members.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02930161


Locations
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Russian Federation
Company "Clinic of professor Gorbakov" Ltd.
Krasnogorsk, Russian Federation, 143405
City Hospital of the Holy Martyr Elizabeth
Saint-Petersburg, Russian Federation, 197706
Medical Company "Hepatologist" Ltd.
Samara, Russian Federation, 443063
Sponsors and Collaborators
POLYSAN Scientific & Technological Pharmaceutical Company
Investigators
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Principal Investigator: Igor G Nikitin Central Clinical Hospital of the Russian Academy of Sciences
Principal Investigator: Vladimir B Grinevich Military Medical Academy named after SM Kirov," the Russian Defense Ministry, 2nd Department and Clinic of medical postrgaduate education
Principal Investigator: Alexander V Gordienko Military Medical Academy named after SM Kirov," the Russian Ministry of Defense, Hospital Therapeutic Department and Clinic
Principal Investigator: Vyacheslav G Morozov Medical company "Hepatologist" Ltd.
Principal Investigator: Vladimir V Gorbakov Company "Clinic of professor Gorbakov" Ltd.
Principal Investigator: Chavdar S Pavlov First Moscow State Medical University named after IM Sechenov, Russian Federation Ministry of Public Health, University Clinical Hospital №2,
Principal Investigator: Michael A Osadchuk First Moscow State Medical University named after IM Sechenov, Health Ministry of the Russian Federation, Outpatient Department
Principal Investigator: Andrew Yu Baranovsky St. Petersburg State health care institution "City Clinical Hospital №31"
Principal Investigator: 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
Principal Investigator: Viktor D Pasechnikov Stavropol State Medical University, Ministry of Health of the Russian Federation, Department of therapy with a course of dietetics
Principal Investigator: Maria A Livzan Omsk State Medical Academy, Ministry of Health and Social Development of the Russian Federation, Department of faculty therapy
Principal Investigator: Yuri P Uspenskiy St. Petersburg City Hospital of the Holy Martyr Elizabeth
Principal Investigator: David L Nepomnyashchikh State Novosibirsk Regional Clinical Hospital
Principal Investigator: Polina M Hlyabova Limited Liability Company "BioEk" Ltd.
Principal Investigator: Sergei L Grishaev St. Petersburg state healthcare institution "Mariinsky Outpatient Clinic"

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Responsible Party: POLYSAN Scientific & Technological Pharmaceutical Company
ClinicalTrials.gov Identifier: NCT02930161     History of Changes
Other Study ID Numbers: RUN-II-2015
First Posted: October 12, 2016    Key Record Dates
Last Update Posted: February 8, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by POLYSAN Scientific & Technological Pharmaceutical Company:
Nonalcoholic Fatty Liver Disease
Nonalcoholic Steatohepatitis
Methionine
Succinic acid
Additional relevant MeSH terms:
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Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Digestive System Diseases