CTRI/2025/01/079324尚未招募3 期
Evaluation of efficacy and safety of liver support formula in patients with nonalcoholic fatty liver disease: A randomized, double blind, interventional, prospective clinical study
BVG life Sciences Limited1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2025年2月4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
- 90
- 试验地点
- 1
- 主要终点
- The primary outcome of the study is to evaluate the changes in Ultrasound guided Liver elastography at screening and end of the treatment (Metavir scoring F3 to lower and changes in liver stiffeness in pascal) at 12 week from baseline.
研究概览
简要总结
In the present clinical study, 90 participants with Non-Alcoholic Fatty Liver Disease ( NAFLD) will be subjected to two ayurvedic formulations in two equally divided arms for 12 weeks. The efficacy and safety of these treatments will be assessed through ultrasound-guided liver elastography, liver function tests (LFT), clinical signs and symptoms, as well as reported adverse events, both observed and self-reported.
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 2.Definitive diagnosis of NAFLD (by USG) or NASH by imaging evidence (USG or liver elastography, Metavir scoring F2 and F3 and liver stiffness more than 8kPa) 3.Subjects willing to sign inform consent form.
排除标准
- •1.Other causes of liver disease including evidence of chronic viral hepatitis (Hepatitis B or C) and Biliary obstruction 2.AST more than 500 U/L or ALT more than 300 U/L
- •( Metavir scoring F4 or liver stiffeness more than 17kPa ) 4.Suspected hypersensitivity to contents of study drug 5.Advanced liver disease (e.g. ascites, bleeding esophageal varices and hepatic encephalopathy, hepatic cancer) 6.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 7.Patients with a renal failure 8.Pregnant or lactating women 9.Subjects with Moderate to high Physical activity having energy expenditure of 3.5 to 7 kcal/min 10.Other conditions, which in the opinion of the investigators, makes 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
The primary outcome of the study is to evaluate the changes in Ultrasound guided Liver elastography at screening and end of the treatment (Metavir scoring F3 to lower and changes in liver stiffeness in pascal) at 12 week from baseline.
时间窗: baseline to 12 weeks
次要结局
- evaluate the changes in serum total bilirubin, AST, ALT, serum Bilirubin(baseline to 12 weeks)
- Assessment of change in symptoms of liver disease like anorexia, fatigue, abdominal pain, nausea(baseline to 12 weeks)
- Adverse events profile(baseline to 12 weeks)
- Compliance and tolerability of the investigational product throughout the study(baseline to 12 weeks)
研究者
Sarvesh Kumar Singh
National institute of Ayurveda Jaipur
研究点 (1)
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