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

Liver Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04718051
• Other study ID #: N202007032
• Status: Recruiting
• Phase: Phase 4
• Start date: January 13, 2021
• Est. completion date: December 31, 2021

Study information

• Verified date: December 2020
• Source: Taipei Medical University WanFang Hospital
• Contact: Ming Shun Wu, PHD
• Phone: +886229307930
• Email: vw1017[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Non-alcoholic Fatty Liver Disease

Intervention

Drug:
• Shen Pu Yang Gan Wan
Shen Pu Yang Gan Wan is Traditional Chinese Medicine; in addition, it has a high dose.
• Placebo
Shen Pu Yang Gan Wan is Traditional Chinese Medicine; however, it has a very low dose.

Locations

Country	Name	City	State
Taiwan	Wanfang Hospital	Taipei	Wenshan District

Sponsors (2)

Lead Sponsor	Collaborator
Taipei Medical University WanFang Hospital	Sheng Pu Pharmaceutics Co., Ltd.

Country where clinical trial is conducted

Taiwan, 

References & Publications (1)

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 ? in hepatic stellate cells for their antifibrotic effect. Hepatology. 2012 Apr;55(4):1271-81. doi: 10.1002/hep.24792. Epub 2012 Mar 1. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in AST index	Measure the changes in the index which is AST relate to Liver inflammation	36 weeks
Primary	Change in ACT index	Measure the changes in the index which is ACT relate to Liver inflammation	36 weeks
Primary	Change in HbA1c	Measure the changes in the index which is HbA1c relate to Liver inflammation	36 weeks
Primary	Fibroscan	Measure the changes in the index which is Liver Fibrosis	36 weeks
Secondary	Measuring Body Mass Index	Measuring Body Mass Index (BMI). Measure the changes in index which is Metabolism	36 weeks