search
Back to results

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

Primary Purpose

Liver Diseases

Status
Unknown status
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
Shen Pu Yang Gan Wan
Placebo
Sponsored by
Taipei Medical University WanFang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Diseases

Eligibility Criteria

35 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Wanfang HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Shen Pu Yang Gan Wan

Placebo Comparator

Arm Description

Traditional Chinese Medicine

Placebo Comparator

Outcomes

Primary Outcome Measures

Change in AST index
Measure the changes in the index which is AST relate to Liver inflammation
Change in ACT index
Measure the changes in the index which is ACT relate to Liver inflammation
Change in HbA1c
Measure the changes in the index which is HbA1c relate to Liver inflammation
Fibroscan
Measure the changes in the index which is Liver Fibrosis

Secondary Outcome Measures

Measuring Body Mass Index
Measuring Body Mass Index (BMI). Measure the changes in index which is Metabolism

Full Information

First Posted
January 18, 2021
Last Updated
January 20, 2021
Sponsor
Taipei Medical University WanFang Hospital
Collaborators
Sheng Pu Pharmaceutics Co., Ltd.
search

1. Study Identification

Unique Protocol Identification Number
NCT04718051
Brief Title
S.P.PRO LIVER POWDER is Used to Improve Liver and Metabolic Indexes in People With Non-alcoholic Fatty Liver Disease
Official Title
S.P.PRO LIVER POWDER is Used to Improve Liver and Metabolic Indexes in People With Non-alcoholic Fatty Liver Disease
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 13, 2021 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taipei Medical University WanFang Hospital
Collaborators
Sheng Pu Pharmaceutics Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Shen Pu Yang Gan Wan
Arm Type
Experimental
Arm Description
Traditional Chinese Medicine
Arm Title
Placebo Comparator
Arm Type
Placebo Comparator
Arm Description
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Shen Pu Yang Gan Wan
Intervention Description
Shen Pu Yang Gan Wan is Traditional Chinese Medicine; in addition, it has a high dose.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Shen Pu Yang Gan Wan is Traditional Chinese Medicine; however, it has a very low dose.
Primary Outcome Measure Information:
Title
Change in AST index
Description
Measure the changes in the index which is AST relate to Liver inflammation
Time Frame
36 weeks
Title
Change in ACT index
Description
Measure the changes in the index which is ACT relate to Liver inflammation
Time Frame
36 weeks
Title
Change in HbA1c
Description
Measure the changes in the index which is HbA1c relate to Liver inflammation
Time Frame
36 weeks
Title
Fibroscan
Description
Measure the changes in the index which is Liver Fibrosis
Time Frame
36 weeks
Secondary Outcome Measure Information:
Title
Measuring Body Mass Index
Description
Measuring Body Mass Index (BMI). Measure the changes in index which is Metabolism
Time Frame
36 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ming Shun Wu, PHD
Phone
+886229307930
Email
vw1017@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ming Shun Wu
Organizational Affiliation
Taipei Municipal Wanfang Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Wanfang Hospital
City
Taipei
State/Province
Wenshan District
ZIP/Postal Code
116
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ming Shun Wu
Phone
0229307930
Ext
1248
Email
mswu@tmu.edu.tw

12. IPD Sharing Statement

Citations:
PubMed Identifier
22095555
Citation
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.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs