CTRI/2025/02/080230尚未招募不适用
Evaluation of efficacy and safety of Saroglitazar in the management of Non-alchoholic fatty liver in patients with Metabolic Syndrome-A Prospective Interventional Study
未提供1 个研究点 分布在 1 个国家目标入组 85 人开始时间: 2025年2月17日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 85
- 试验地点
- 1
- 主要终点
- To assess the Efficacy of SAROGLITAZOR in controlling fatty liver progression and rapid recovery from symptoms.
研究概览
简要总结
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 19.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients of both gender and aged above 18 to 75 years.
- •A diagnosis of NAFLD established by fibro scan.
- •Body mass index more than 25 kg per meter square Stable body weight change less than plus or minus 10 percentage of body weight for 3 months before the study.
- •Central obesity: Waist circumference 90 cm or greater in men or 80 cm or greater in women Elevated fasting plasma glucose: fasting plasma glucose of 100 mg per dL or greater or HBA1c greater than 6.5 percentage
- •Patients with Elevated triglycerides serum triglycerides 150 mg per dL or greater or Reduced high-density lipoprotein cholesterol serum HDL-c less than 40 mg per in men or less than 50 mg per dL in women; or Elevated blood pressure systolic blood pressure of 130 mmHg or greater or diastolic blood pressure of 85 mmHg or greater are included.
- •Patients who are able and willing to provide informed consent.
排除标准
- •1.Metabolic syndrome patients with HbA1c greater than 9 percent and or use of thiazolidinediones like pioglitazone, rosiglitazone, CYP2C8 inhibitors , fibrates like clofibrate, fenofibrate.
- •Patients with known cardiovascular and cerebrovascular diseases like coronary heart disease, stroke, or revascularization and malignant tumours.
- •Patients having other chronic liver disease and established diagnosis of cirrhosis .
- •Patient with acute or chronic viral infection within the previous 4 weeks.
- •Alcohol abuse of weekly consumption of alcohol is more than 70 g in women or 140 g in men.
结局指标
主要结局
To assess the Efficacy of SAROGLITAZOR in controlling fatty liver progression and rapid recovery from symptoms.
时间窗: DAY 1 ( BASELINE VALUE) | DAY 45
The change in CAP SCORE from GRADE 1 (5 - 33 percentage) to normal (less than 5 percentage)
时间窗: DAY 1 ( BASELINE VALUE) | DAY 45
次要结局
- To assess the metabolic syndrome severity score saroglitazar 4mg before and after administration.(To check body weight, waist hip ratio, blood pressure, glycemic control)
研究者
Dr S Sarumathy MPharm PhD
SRM, College of Pharmacy, SRMIST
研究点 (1)
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