Comparative Evaluation of Oral Ursodeoxycholic Acid in Reducing Bilirubin Levels Among Patients With Acute Viral Hepatitis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 88
- 主要终点
- Change in serum total bilirubin levels
研究概览
简要总结
Hepatitis is an inflammatory condition of the liver that has emerged as a significant global health concern due to its widespread prevalence.
Data on ursodeoxycholic acid in acute viral hepatitis remain limited. Some studies suggest its positive effect in cholestatic phase of viral hepatitis. UDCA may reduce cholestatic symptoms like jaundice and pruritus potentially shortening hospital stay and improving patient outcomes. However, robust clinical data supporting its routine use in acute viral hepatitis are lacking, and current treatment remains largely supportive. Given the high burden of acute viral hepatitis in our region and the potential for UDCA to improve cholestatic phase of AVH there is a clear need for well-designed clinical studies evaluating its therapeutic role. This study aims to evaluate the role of oral ursodeoxycholic acid in biochemical recovery of patients with acute viral hepatitis. If positive role is confirmed, it will be incorporated in standard treatment and if no role is found unnecessary use will be discouraged.
Null Hypothesis (H₀):
Oral ursodeoxycholic acid has no significant effect on the bilirubin levels of patients with acute viral hepatitis.
H₀: There is no statistically significant difference in bilirubin levels between patients receiving ursodeoxycholic acid and those receiving supportive care alone.
Alternative Hypothesis (H₁):
Oral ursodeoxycholic acid reduces bilirubin levels in patients with acute viral hepatitis. H₁: There is statistically significant difference in bilirubin levels between patients receiving ursodeoxycholic acid and those receiving supportive care alone.
详细描述
Study design: A Quasi-experimental design There is an intervention group (receiving UDCA + standard care) and a control group (receiving standard care only) Study Setting: Medicine department of Combined Military Hospital, Malir, Karachi Study Duration: 6 months Sampling Technique: Non probability consecutive sampling technique
Sample Size:
Open Epi version 3, was used to calculate the sample size with a two-sided 95% confidence interval and 80% power. This was based on an expected mean difference of 0.3 mg/dL in bilirubin levels between the treatment group (mean = 4.1 mg/dL, SD = 0.5) and the control group (mean = 3.8 mg/dL, SD = 0.5) (6), a minimum of 44 participants per group was calculated to detect this difference, assuming equal variances and group sizes. The total sample size is calculated to be 88 (total N = 88), with 44 participants in each group.
Since the total estimated number of eligible admissions during the study period was 200 and the required sample size was 88, a sampling interval (k) of approximately 2 was calculated (k = 200/88 ≈ 2). A random starting point was selected to avoid periodic bias, and thereafter every 2nd eligible patient was included until the desired sample size was achieved.
Inclusion Criteria All patients of either gender, aged >18 years to 50 years with acute viral hepatitis are included.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients of either gender
- •aged >18 years to 50 years with acute viral hepatitis are included
排除标准
- •Patients having Hepatitis B, C
- •hepatocellular carcinoma
- •primary biliary cholangitis
- •choldocholithiasis
- •patients having normal bilirubin levels with AVH were excluded.
研究组 & 干预措施
Control Group
Supportive management for acute viral hepatitis
干预措施: Supportive Care (Other)
UDCA
Patients receiving ursodeoxycholic acid in addition to standard care
Intervention:
干预措施: Ursodeoxycholic Acid (Drug)
结局指标
主要结局
Change in serum total bilirubin levels
时间窗: 7 days
Mean reduction in serum total bilirubin from baseline to Day 7 in patients receiving ursodeoxycholic acid compared to control group
次要结局
未报告次要终点
研究者
Khuld e Neha
Postgraduate trainee
Combined Military Hospital, Pakistan