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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Liver Diseases

Intervention / Treatment
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* Drug: Shen Pu Yang Gan Wan
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Female patients are pregnant or breastfeeding. Patients with viral hepatitis. Long-term drinkers. Those who use slimming products and vitamin E.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Shen Pu Yang Gan Wan<br>Traditional Chinese Medicine | Drug: Shen Pu Yang Gan Wan<br>* Shen Pu Yang Gan Wan is Traditional Chinese Medicine; in addition, it has a high dose.<br>|
| Placebo Comparator: Placebo Comparator<br>Placebo Comparator | Drug: Placebo<br>* Shen Pu Yang Gan Wan is Traditional Chinese Medicine; however, it has a very low dose.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in AST index | Measure the changes in the index which is AST relate to Liver inflammation | 36 weeks | 
| Change in ACT index | Measure the changes in the index which is ACT relate to Liver inflammation | 36 weeks | 
| Change in HbA1c | Measure the changes in the index which is HbA1c relate to Liver inflammation | 36 weeks | 
| Fibroscan | Measure the changes in the index which is Liver Fibrosis | 36 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measuring Body Mass Index | Measuring Body Mass Index (BMI). Measure the changes in index which is Metabolism | 36 weeks |