ISRCTN11412541进行中（未招募）未知
Efficacy of Twin Precision treatment in patients with non-alcoholic fatty liver disease - a multicenter, open-label, parallel-arm, randomized controlled trial
TWINS Digital Services India pvt ltd0 个研究点目标入组 79 人开始时间: 2022年4月18日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 79
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Patients with NAFLD (either ELF score > 7.7 or MRE with kPa 2.5 to 5) or with a histological diagnosis of NASH (biopsy < 6 months old)
- •2. Age =18 years of age of either gender
- •3. BMI 19 kg/m² and above
- •4. Non-diabetic or diabetic (HbA1c <9%) on a stable dose of antidiabetic medications for the last 3 months
- •5. Willing to provide written informed consent and comply with the study protocol
排除标准
- •1. Those with a history of significant alcohol consumption. Significant alcohol intake is considered when alcohol consumption >7 standard drinks/week (70 g ethanol) in women and >14 standard drinks/week (140 g ethanol) in men (according to Asia-Pacific Guidelines)
- •2. AUDIT score >8 indicating harmful alcohol consumption
- •3. Patients with a diagnosis liver disease due to other etiologies such as alcohol or drug abuse, medication, chronic hepatitis B or C, autoimmune, hemochromatosis, Wilson’s disease, a1-antitrypsin deficiency
- •4. Those with clinical evidence of hepatic decompensation such as a history of ascites, esophageal bleeding varices, or spontaneous encephalopathy
- •5. Those with evidence of portal hypertension such as low platelet counts (< 1.5 lakhs per microlitres), esophageal varices, ascites, history of hepatic encephalopathy, splenomegaly (moderate, severe)
- •6. Child-Pugh class B/C
- •7. ALT and AST elevation greater than five times the upper limit of normal (ULN)
- •8. Alkaline phosphatase more than 2 ULN (less than 250–300 271 U/L)
- •9. Severe hypertension either treated or untreated. (defined as systolic blood pressure (SBP) >180 mmHg or diastolic blood pressure (DBP) >100 mmHg)
- •10. Patients with a history of clinically significant heart disease (New York Heart Association (NYHA) Class greater than grade II), peripheral vascular disease (history of claudication), or diagnosed pulmonary disease
- •11. History of bariatric surgery or intestinal bypass surgery within the 5 years prior to randomization or planned during the conduct of the study
- •12. Change in body weight more than 5% in the last 3 months
- •13. History of malignancy in the last 5 years
- •14. Active, serious medical disease with a likely life expectancy <2 years
- •15. Participation in an investigational new drug trial in the 60 days or 5 half-lives, whichever is longer, prior to randomization
- •16. Patients on supplements for weight loss, pioglitazone, vitamin E
- •17. Pregnant and lactating women and postpartum up to 2 years
- •18. Those with contraindications for MR elastography
- •19. Any other condition that, in the opinion of the Investigator, would impede compliance, hinder completion of the study, compromise the well-being of the patient, or interfere with the study outcomes
研究者
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