S.P.PRO LIVER POWDER is Used to Improve Liver and Metabolic Indexes in People With Non-alcoholic Fatty Liver Disease
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jan 2021
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 13, 2021
CompletedFirst Submitted
Initial submission to the registry
January 18, 2021
CompletedFirst Posted
Study publicly available on registry
January 22, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2021
CompletedJanuary 22, 2021
December 1, 2020
12 months
January 18, 2021
January 20, 2021
Conditions
Outcome Measures
Primary Outcomes (4)
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 Outcomes (1)
Measuring Body Mass Index
36 weeks
Study Arms (2)
Shen Pu Yang Gan Wan
EXPERIMENTALTraditional Chinese Medicine
Placebo Comparator
PLACEBO COMPARATORPlacebo Comparator
Interventions
Shen Pu Yang Gan Wan is Traditional Chinese Medicine; in addition, it has a high dose.
Shen Pu Yang Gan Wan is Traditional Chinese Medicine; however, it has a very low dose.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Female patients are pregnant or breastfeeding.
- Patients with viral hepatitis.
- Long-term drinkers.
- Those who use slimming products and vitamin E.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Wanfang Hospital
Taipei, Wenshan District, 116, Taiwan
Related 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 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.
PMID: 22095555BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ming Shun Wu
Taipei Municipal Wanfang Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 18, 2021
First Posted
January 22, 2021
Study Start
January 13, 2021
Primary Completion
December 31, 2021
Study Completion
December 31, 2021
Last Updated
January 22, 2021
Record last verified: 2020-12