A Randomized, Double-Blind, Three Arm, Placebo-Controlled Trial to Evaluate the Antioxidant, Antiobesity and rejuvenation Potential of Sesame extract - S3 complex in Adults Suffering with NAFLD.
试验速览
- 阶段
- Phase 3 4
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Primary Outcomes:
研究概览
简要总结
Nonalcoholic fatty liver disease (NAFLD) is a chronic liver disease in which triglycerides accumulate within the hepatocytes of patients with minimal or no alcohol intake and without any other known cause. It comprises a wide spectrum of liver damage ranging from steatosis to nonalcoholic steatohepatitis (NASH), advanced fibrosis and cirrhosis [liu JP et al 2016]. For the sake of terminology, NAFLD is comprised of non-alcoholic fatty liver (NAFL) and non-alcoholic steatohepatitis (NASH). NAFL is characterized by steatosis of the liver, involving greater than 5% of parenchyma, with no evidence of hepatocyte injury. Whereas, NASH is defined by histologic terms, that is a necro inflammatory process whereby the liver cells become injured in a background of steatosis [Benedict M et al 2017]. Obesity has become a major health concern not only in high income countries, but also in low- and middle-income populations.
The pathogenesis of NAFLD involves oxidative stress, inflammation, and lipid metabolism dysregulation. Sesamolin, a major lignan present in sesame seeds, has been demonstrated to exhibit antioxidant, anti-inflammatory, and lipid-lowering properties, making it a potential therapeutic agent for NAFLD and obesity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Double
入排标准
- 年龄范围
- 20.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Adults aged between 20 to 65 years of either sex with USG findings suggestive of NonAlcoholic Fatty Liver Disease grade I II and III.
- •BMI 25 to 35 kg per m2
- •Newly onset Diabetes mellitus (not more than 10 years)
- •Newly onset Hypertension (not more than 10 years)
- •Lipid profile a.
- •Lower HDL level b.
- •Higher LDL Triglyceride TC level
- •Liver function test AST or ALT (within more than 3 times of the upper limit of normal range)
- •Willing to participate in the study with a signed and dated written consent.
- •Able to comply with all required study procedures and schedule.
- •Able to comply and willing to follow the prescribed diet plan.
排除标准
- •Alcoholic and smoking.
- •Bariatric surgery within the last year.
- •Surgery within the last six months.
- •Severe cerebrovascular disease (cerebral infarction and cerebral hemorrhage) heart disease (angina pectoris myocardial infarction heart failure and arrhythmia requiring treatment) or malignant tumours within the last six months.
- •Taking drugs that affect body weight (fat absorption inhibitors appetite suppressants health food or supplements related to obesity psychiatric drugs betablockers diuretics contraceptives steroids and female hormones) within the last month.
- •Obese or overweight due to endocrine diseases (hypothyroidism Cushings syndrome).
- •Maintenance treatment acute and chronic for gastrointestinal disorders (gastric ulcer chronic digestive disorder irritable bowel syndrome).
- •Psychologically significant medical history or current disease (schizophrenia epilepsy anorexia bulimia) or a history of alcohol and other drug abuse.
- •Malabsorption syndrome autoimmune disease.
- •Participation in a commercial obesity program or obesity clinical trial within the last three or six months respectively.
- •Pregnancy lactation or planning to become pregnant during the study period.
- •Women not using a correct contraceptive method.
- •Allergic reaction to the study drug or herbal extractsdietary supplements.
- •Duration of jaundice greater than 3 months steatohepatitis advanced fibrosis cirrhosis viral hepatitis or other liver diseases.
- •Patients on immunomodulatory drugs coronary artery disease treatment or hepatoprotective drugs.
- •Treatment of NAFLD for at least three months prior to screening.
- •Receipt of any investigational drug or participation in another clinical trial within the preceding month.
- •Liver transplantation.
- •Use of Ayurvedic formulation or Complementary Alternative Medicine (CAM) therapy within the preceding two months.
- •Any condition that in the investigators opinion does not justify the patients inclusion for the study.
结局指标
主要结局
Primary Outcomes:
时间窗: Screening visit, day 0, day 30,day 60, day 90.
1.Change in Percentage of patients who show improvement in liver Ultrasonography evaluation as compared to screening visit (Degree of
时间窗: Screening visit, day 0, day 30,day 60, day 90.
fatty infiltration, Hepatomegaly or hyper echoic shadow or resolution
时间窗: Screening visit, day 0, day 30,day 60, day 90.
of Ascites) from baseline to day 90
时间窗: Screening visit, day 0, day 30,day 60, day 90.
2.Change in Hepatic Steatosis index form baseline to day 90
时间窗: Screening visit, day 0, day 30,day 60, day 90.
3. Change in DEXA Scan form Day 0 to day 90
时间窗: Screening visit, day 0, day 30,day 60, day 90.
4.Change in Quality-of-Life Questionnaires (CLDQ) from baseline to Day 30, 60 and 90.
时间窗: Screening visit, day 0, day 30,day 60, day 90.
5.Change in BMI from baseline to Day 90.
时间窗: Screening visit, day 0, day 30,day 60, day 90.
6.Change in Body fat from baseline to Day 90.
时间窗: Screening visit, day 0, day 30,day 60, day 90.
次要结局
- Secondary Outcomes:(1.Change in Liver function parameters (AST, ALT, GGT and Total bilirubin, direct and indirect bilirubin, albumin and globulin) from)
研究者
Dr Ashok Godavarthi
Radiant Research Services Pvt Ltd