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

Phase 4

• Conditions: Liver Diseases
• Interventions: Drug: Shen Pu Yang Gan Wan; Drug: Placebo

• Registration Number: NCT04718051
• Lead Sponsor: Taipei Medical University WanFang Hospital

Brief Summary

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

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.

Study Timeline

• Status Verified: 2020-12
• Study Start: 2021-01-13
• Study First Submitted: 2021-01-18
• Study First Submitted QC: 2021-01-20
• Last Update Submitted: 2021-01-20
• Study First Posted: 2021-01-22
• Last Update Posted: 2021-01-22
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Shen Pu Yang Gan Wan	Shen Pu Yang Gan Wan	Traditional Chinese Medicine
Placebo Comparator	Placebo	Placebo Comparator

Primary Outcome Measures

Name	Time	Method
Fibroscan	36 weeks	Measure the changes in the index which is Liver Fibrosis
Change in AST index	36 weeks	Measure the changes in the index which is AST relate to Liver inflammation
Change in ACT index	36 weeks	Measure the changes in the index which is ACT relate to Liver inflammation
Change in HbA1c	36 weeks	Measure the changes in the index which is HbA1c relate to Liver inflammation

Secondary Outcome Measures

Name	Time	Method
Measuring Body Mass Index	36 weeks	Measuring Body Mass Index (BMI). Measure the changes in index which is Metabolism

Trial Locations

Locations (1)

Wanfang Hospital; 🇨🇳 Taipei, Wenshan District, Taiwan