CTRI/2024/03/063735已完成3 期
Effect of Saroglitazar on hepatic steatosis in non-alcoholic fatty liver disease patients: a randomised double blind placebo controlled trial
No sponsor1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2024年3月31日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Mean change from baseline in CAP values on Fibroscan
研究概览
简要总结
There is currently no guideline on Pharmacotherapy of NAFLD in non diabetic patients, one
retrospective observational study has been conducted but no clinical trials for use of Saroglitazar in non diabetic non alcoholic patient is available hence this study will generate evidence for the use of Saroglitazar in non diabetic NAFLD patients â¦
Saroglitazar in a drug approved for diabetic dyslipidemia and there are clinical trials which have shown the efficacy on NAFLD in patients with diabetic dyslipidemia
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •i) Age -18-60 years ii) Either of the gender (Male and female) iii)Evidence of fatty liver on USG iv) Patient’s willingness to comply with the study protocol and prior written informed consent.
排除标准
- •Alcoholics for past 6 months 2)Patients with type i or type 2 diabetes mellitus 3) Patients with alternate causes of fatty liver including: -Patients on TPN and those who underwent surgical procedures within 90 days from randomization -presence of other chronic liver disease such as hepatitis B or C, liver cirrhosis, Wilson’s disease or any other autoimmune condition leading to fatty liver 4) Use of drugs with potential effect on NASH such as: Ursodeoxycholic acid, SAdenosyl Methionine(SAM-e), Betaine, Pentoxyfylline, Obeticholic acid, milk thistle, Vitamin E, statins, CYP3C8 inhibitors or substrate -within 3 months before visit 1 5) Presence of bleeding disorders, myopathy, malignancy, hypothyroidism 6) Presence of anaemia, acute or chronic kidney disease, acute or chronic liver disease 7) Participation in other NAFLD/NASH related study within last 3 months 8) Pregnant or lactating females or couples planning pregnancy within 3 months.
结局指标
主要结局
Mean change from baseline in CAP values on Fibroscan
时间窗: 24 weeks
次要结局
- Mean change from baseline in serum alanine amino transferase values(24 weeks)
- Mean change from baseline in lipid profile(24 weeks)
- Mean change from baseline in FBS, HbA1c, HOMA-IR(24 weeks)
- Mean change from baseline in BMI, body weight, Waist-Hip ratio(24 weeks)
- Mean change in LSM values from baseline(24 weeks)
- Mean change in FIB-4 score(24 weeks)
- Mean change in Hepatic steatosis index(24 weeks)
研究者
Dr Divya Harsha
All India Institute of Medical Sciences
研究点 (1)
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