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临床试验/NCT04718051
NCT04718051Unknown4 期

S.P.PRO LIVER POWDER is Used to Improve Liver and Metabolic Indexes in People With Non-alcoholic Fatty Liver Disease

Taipei Medical University WanFang Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年1月13日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
入组人数
60
试验地点
1
主要终点
Fibroscan

研究概览

简要总结

With the Westernization of the diet and insufficient exercise, Taiwan's population of obesity, diabetes, and hyperlipidemia has increased in recent years, and the prevalence of the non-alcoholic fatty liver disease has gradually increased. Although weight loss, dietary adjustments, and certain drug treatments can delay the deterioration of the disease; however, weight loss and dietary adjustment are not easy.

详细描述

With the Westernization of the diet and insufficient exercise, Taiwan's population of obesity, diabetes, and hyperlipidemia has increased in recent years, and the prevalence of the non-alcoholic fatty liver disease has gradually increased. Although weight loss, dietary adjustments, and certain drug treatments can delay the deterioration of the disease; however, weight loss and dietary adjustment are not easy. Moreover, drugs also have side effects, and there is currently no convenient and effective treatment for people who have non-alcoholic fatty liver disease. The purpose of this trial is that investigating and evaluating the effects on fatty liver, liver fiber, and metabolic indexes after subjects using Shen Pu Yang Gan Wan.

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
Single (Participant)

入排标准

年龄范围
35 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with fatty liver diagnosed by abdominal ultrasound or hepatic fibrometer within half a year's data
  • Subjects with the non-alcoholic fatty liver disease
  • The severity of fatty liver should be at least 3 points by taking an abdominal ultrasound

排除标准

  • Female patients are pregnant or breastfeeding.
  • Patients with viral hepatitis.
  • Long-term drinkers.
  • Those who use slimming products and vitamin E.

研究组 & 干预措施

Shen Pu Yang Gan Wan

Experimental

Traditional Chinese Medicine

干预措施: Shen Pu Yang Gan Wan (Drug)

Placebo Comparator

Placebo Comparator

Placebo Comparator

干预措施: Placebo (Drug)

结局指标

主要结局

Fibroscan

时间窗: 36 weeks

Measure the changes in the index which is Liver Fibrosis

Change in AST index

时间窗: 36 weeks

Measure the changes in the index which is AST relate to Liver inflammation

Change in ACT index

时间窗: 36 weeks

Measure the changes in the index which is ACT relate to Liver inflammation

Change in HbA1c

时间窗: 36 weeks

Measure the changes in the index which is HbA1c relate to Liver inflammation

次要结局

  • Measuring Body Mass Index(36 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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