NCT04761848撤回1 期
Evaluation the Safety and Efficacy of Cilostazol in Treatment of Patients With Fatty Liver Disease: A Randomized, Controlled Trial.
Sadat City University1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2021年2月16日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Hepatic transaminases
研究概览
简要总结
The aim of the current study is to evaluate the safety and efficay of cilostazol in treatment of patients with fatty liver disease. Several previous reports have shown that cilostazol ameliorates lipid imbalances in NAFLD. Cilostazol appeared to exert beneficial effects against NAFLD
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults between 18 and 60 years of age, both men and women,
- •Clinical diagnosis of NAFLD, confirmed by imaging exams,
- •Patients who present levels above the reference values of ALT, AST and ferritin.
排除标准
- •Women in the menacing period, with the exception of those who have performed definitive sterilization, such as hysterectomy or tubal ligation.
- •Patients with established prior diagnosis of chronic noncommunicable disease (congestive heart failure, decompensated or severe lung disease, neoplasms, renal disease, advanced liver disease - Child Pugh C classification)
- •Patients with schistosomiasis;
- •Hemochromatosis
- •Wilson's disease
- •Viral or autoimmune hepatitis
- •HIV virus carriers
- •Woman who is breastfeeding
- •Users of illicit drugs
- •Patients with an intake of more than 20 g / day of alcohol and / or past alcoholism with abstention less than 6 months;
- •Patients with ingestion of medications such as steroids, estrogens, amiodarone, warfarin, anti-convulsants, antipsychotics, tamoxifen or other chemotherapeutic agents in the last 6 months
- •Patients with clinically manifest infections or inflammation, surgery, trauma or hospitalization in the last 30 days
- •Chronic non-hepatic degenerative diseases (sclerosis, Parkinson's disease or -Alzheimer's disease)
- •Patients who do not participate in all stages of the research.
研究组 & 干预措施
Cilostazol
Experimental
干预措施: Cilostazol 50 MG (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Hepatic transaminases
时间窗: week 12
Alanine aminotransferase (ALT) and Aspartate Aminotransferase (AST) will be evaluated in U/L
Serum ferritin
时间窗: week 12
Serum ferritin
次要结局
- Lipid profile(week 12)
- Glycated haemoglobin(week 12)
- Serum stem cell transforming factor beta(12 weeks)
- Adverse effects(12 weeks)
- FAM19A5 serum level(12 weeks)
研究者
Mahmoud Samy Abdallah
Lecturer of Clinical Pharmacy
Sadat City University
研究点 (1)
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