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

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.

Study Overview

• Status: Unknown
• Conditions: Liver Diseases
• Intervention / Treatment: Drug: Shen Pu Yang Gan Wan; Drug: Placebo

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• Taiwan
  • Wenshan District
    • Taipei, Wenshan District, Taiwan, 116
      • Recruiting
      • Wanfang Hospital
      • Contact: Ming Shun Wu; Phone Number: 1248 0229307930; Email: mswu@tmu.edu.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo Comparator	Drug: Placebo; Shen Pu Yang Gan Wan is Traditional Chinese Medicine; however, it has a very low dose.
EXPERIMENTAL: Shen Pu Yang Gan Wan; Traditional Chinese Medicine	Drug: Shen Pu Yang Gan Wan; Shen Pu Yang Gan Wan is Traditional Chinese Medicine; in addition, it has a high dose.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Taipei Medical University WanFang Hospital
• Collaborators: Sheng Pu Pharmaceutics Co., Ltd.

Publications and helpful links

General Publications

• Yang MD, Chiang YM, Higashiyama R, Asahina K, Mann DA, Mann J, Wang CC, Tsukamoto H. Rosmarinic acid and baicalin epigenetically derepress peroxisomal proliferator-activated receptor gamma in hepatic stellate cells for their antifibrotic effect. Hepatology. 2012 Apr;55(4):1271-81. doi: 10.1002/hep.24792. Epub 2012 Mar 1.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 13, 2021
• Primary Completion (ANTICIPATED): December 31, 2021
• Study Completion (ANTICIPATED): December 31, 2021

Study Registration Dates

• First Submitted: January 18, 2021
• First Submitted That Met QC Criteria: January 20, 2021
• First Posted (ACTUAL): January 22, 2021

Study Record Updates

• Last Update Posted (ACTUAL): January 22, 2021
• Last Update Submitted That Met QC Criteria: January 20, 2021
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: N202007032

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No