CTRI/2024/10/075231尚未招募4 期
A prospective, randomized, assessor blinded, two arm, comparative, Phase IV, single center, investigator initiated clinical study to assess the impact of nano formulation of ursodeoxycholic acid as compared to conventional formulation of ursodeoxycholic acid on liver markers in patients with liver diseases.
Dr Parth Shah1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年10月19日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Percentage change in AST levels
研究概览
简要总结
In this study, patients with established diagnosis of liver diseases including NAFLD, drug induced hepatitis, acute viral hepatitis, Alcoholic hepatitis with elevated liver enzymes (at least 2 times upper limit of normal) requiring treatment with UDCA will be screened and enrolled if found eligible (visit 1). All the eligible patients will be followed up on an outpatient basis with scheduled visits at end of day 14 ± 2 days (visit 2) and day 28 ± 2 days (visit 3). This will be a two-arm study and all the enrolled patients will be instructed to take the study medication for a treatment period of 28 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients of either gender between 18-65 years of age (both inclusive)
- •Patients with established diagnosis of NAFLD, drug induced hepatitis, acute viral hepatitis, alcoholic hepatitis
- •Patients with elevated liver enzymes (at least 2 times upper limit of normal) requiring treatment with UDCA
- •Patients willing to provide written informed consent and comply with the protocol requirements.
排除标准
- •1.Patients who have used UDCA in last three months 2.Patients with recurrent variceal bleeding, spontaneous portosystemic encephalopathy, diuretic-resistant ascites, bacterial peritonitis or anticipated need for transplantation within 1 year 3.Patients using any other prescribed or over the counter medication affecting liver function at screening 4.Patients with known hypersensitivity to the study drug 5.Pregnant or Lactating females; or female patients of childbearing potential unwilling to use effective contraception 6.Participation in another clinical trial within 3 months prior to screening 7.Patients with renal dysfunction (creatinine more than 1.5 of ULN) at screening 8.Patients with any other clinically significant cardiac, endocrine, pulmonary, gastrointestinal or neurological disorder 9.Participation in another clinical trial within 3 months prior to screening 10.Any other reason for which the investigator feels that the patient should not participate.
结局指标
主要结局
Percentage change in AST levels
时间窗: Baseline(Day 0) Vs Day 28
次要结局
- Percentage change in ALT, ALP, GGT and bilirubin levels(Baseline(Day 0) Vs Day 7,14,21,28)
- Percentage change in AST level(Baseline(Day 0) Vs Day 7,14,21)
- Proportion of patients achieving normal AST, ALT GGT and bilirubin levels(at 7 days, 14 days, 21 days and 28 days)
- Adverse events reported during the study(Basline (Day 0) to End of study)
- Serious adverse events reported during the study(Basline (Day 0) to End of study)
研究者
Dr Jayesh Sanmukhani
Clinexcel Research
研究点 (1)
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