Многоцентровое двойное слепое плацебо-контролируемое рандомизированное исследование препарата Рунихол® у пациентов с неалкогольной жировой болезнью печени на фоне метаболического синдрома
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 35
- 试验地点
- 3
- 主要终点
- Proportion of responders to treatment
研究概览
简要总结
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.
详细描述
The aim of this study is a comparative assessment of the safety and efficacy of different doses and dosing regimens of Runihol drug tablets, enteric coated, produced by "NTFF" POLYSAN "(Russia) and placebo tablets, enteric coated, produced by" NTFF "POLYSAN" (Russia), when administered to patients with non-alcoholic fatty liver disease and metabolic syndrome.
Design: a multicenter, prospective, randomized, double-blind, placebo-controlled comparative study in parallel groups.
The study will be performed on the outpatient basis under the supervision of the physician-researcher who will be in charge of screening and the whole course of study drug therapy.
The study consists of the following periods:
- Screening - preliminary examination of the eligible patients (duration 14 days).
- The period of therapy - the use of the study drug Runihol®, tablets, enteric coated, produced by "NTFF" POLYSAN "(Russian) or placebo tablets, enteric coated, produced by" NTFF "POLYSAN" LLC (Russia), during 84 days (12 weeks).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A signed informed consent to participate in the study.
- •Men and women aged 18 to 65 years.
- •Diagnosis: non-alcoholic fatty liver disease (code ICD-10: K76.0 Fatty degeneration of the liver, not classified elsewhere), defined as non-alcoholic steatohepatitis.
- •Metabolic syndrome (according to the national criteria accepted in 2013).
- •The body mass index (BMI) of 30-45 kg / m
- •The presence of signs of steatosis on ultrasound examination of the liver (distal signal attenuation and / or increased echogenicity of the liver).
- •The level of total cholesterol> 6.0 mmol/l and / or triglyceride levels> 1.7 mmol/l.
- •ALT, AST serum levels exceed upper normal limits by 1,5-7 times.
- •GGT level higher that upper normal limit by 1,5-7 times.
- •The level of SBP>140 and / or DBP> 90 mm Hg or antihypertensive therapy required to maintain normal blood pressure values.
- •A negativepregnancy test for female participants.
- •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.
- •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.
排除标准
- •Chronic liver disease of any other aetiology.
- •Disorders of copper metabolism, and/or ceruloplasmin serum level beyond the reference value on screening.
- •Disorders of iron metabolism in the past medical history or revealed at screening.
- •Cirrhotic stage of nonalcoholic fatty liver disease (Class A-C by Child-Pugh).
- •Type I diabetes mellitus.
- •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.
- •Any severely decompensated somatic disease
- •Regular intake of the medications that are prohibited by the study protocol, or their intake within 4 weeks prior to inclusion.
- •The history of clinically significant allergic reactions.
- •Hypersensitivity to any component of the study drug and / or intolerance to any component of the study drug.
- •Bariatric surgery in less than 6 months prior to the study.
- •Pregnancy or lactation.
- •Hyperhomocysteinemia (homocysteine serum levels >15 mmol/dL for men, >12 mmol/dL for women).
- •Exacerbation of the stomach ulcer and / or duodenal ulcers and / or erosive gastritis.
- •Chronic kidney failure (stage C4-C5) and / or glomerular filtration rate <30 ml / min on screening.
- •Gout, with the need of drugs that reduce uric acid levels
- •Any of the following parameters: Hb <80 g / L, platelets <80 x 10 9 / L, WBC> 15 x 10 9 / L at screening.
- •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.
- •A significant (over 5 kg) weight loss or weight gain during the preceding 6 months prior to the study.
- •Unstable angina pectoris.
- •Myocardial infarction within 3 months before inclusion.
- •Chronic heart failure (III-IV functional class by NYHA).
- •A history of cancer, mental illness, HIV, tuberculosis, or drug addiction.
- •Mental, physical and other reasons that do not allow the patient to comply with the study procedures.
- •Any other condition which, according to the investigator's judgement, may interfere with the compliance to study procedures.
- •Participation in any other clinical trial within 3 months prior to the inclusion.
- •Employees of the research company or study site involved in the conduct of the present study, and their family members.
研究组 & 干预措施
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).
干预措施: Runihol (Drug)
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).
干预措施: Runihol (Drug)
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).
干预措施: Placebo (Other)
结局指标
主要结局
Proportion of responders to treatment
时间窗: 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
次要结局
- Severity of dyslipidemia(102 days, including the screening period (14 days))
- The insulin resistance index (HOMA-IR)(102 days, including the screening period (14 days))
- Transaminases(102 days)
- cholestasis markers (alkaline phosphatase, GGT)(102 days)
- Bilirubin(102 days)
- Body mass index(102 days)
- ultrasound signs of hepatic steatosis(102 days)