CTRI/2025/04/084033尚未招募3 期
A randomized, double-blind clinical study to assess efficacy and safety of polyherbal formulation in non-alcoholic fatty liver patients.
PALS Limited1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年4月15日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Assessment of changes in serum total bilirubin, AST and ALT
研究概览
简要总结
| In the present study, 60 subjects with clinical symptoms of Non-Alcoholic Fatty Liver Disease (NAFLD) will be subjected to two ayurvedic formulations in two equally randomized arms of 30 participants each for 12 weeks. The efficacy and safety of these treatments will be assessed through LFT, clinical signs and symptoms, as well as reported adverse events, both reported and self-observed. |
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Diagnosis of hepatic disorder with abnormal LFT with or without signs and symptoms such as dark-colored urine, light-colored stools, pruritus, pruritic red hives, fever, nausea, vomiting, anorexia, and right upper abdominal discomfort, pain or feeling of pressure.
- •3.Subjects willing to sign inform consent form.
排除标准
- •Other causes of liver disease including evidence of chronic viral hepatitis (Hepatitis B or C) and biliary obstruction
- •AST > more than 500 U/L or ALT > more than 300 U/L
- •Suspected hypersensitivity to contents of study drug
- •Advanced liver disease (e.g. ascites, bleeding esophageal varices and hepatic encephalopathy, hepatic cancer)
- •Subjects with serious illness, e.g., uncontrolled diabetes, multisystem failure, HIV, cancer, severe renal insufficiency, serious cardiovascular disease and patients with history of gastritis, peptic ulcer, bleeding ulcer
- •Patients with a renal failure
- •Pregnant or lactating women
- •Subjects with moderate to high physical activity having energy expenditure of 3.5 to 7 kcal/min
- •Other conditions, which in the opinion of the investigators, make the patient unsuitable for enrollment or could interfere with his/her participation in, and completion of the protocol.
结局指标
主要结局
Assessment of changes in serum total bilirubin, AST and ALT
时间窗: baseline to 12 weeks.
次要结局
- Assessment of change in symptoms of liver disease like anorexia, fatigue, abdominal pain, and nausea.(baseline to 12 weeks.)
- Adverse events profile(baseline to 12 weeks.)
- Compliance and tolerability of the product throughout the study .(baseline to 12 weeks.)
研究者
Dr Sarvesh Kumar Singh
National Institute of Ayurveda Jaipur
研究点 (1)
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