Clinical trial NCT04718051: 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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Liver Diseases
Lead sponsor: Taipei Medical University WanFang Hospital
Sponsor class: OTHER
Collaborators: name: Sheng Pu Pharmaceutics Co., Ltd.
First posted: 2021-01-22
Enrollment: 60
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in AST index
timeFrame: 36 weeks
measure: Change in ACT index
timeFrame: 36 weeks
measure: Change in HbA1c
timeFrame: 36 weeks
measure: Fibroscan
timeFrame: 36 weeks
Secondary outcomes:
measure: Measuring Body Mass Index
timeFrame: 36 weeks
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Wanfang Hospital
state: Wenshan District
Study officials:
affiliation: Taipei Municipal Wanfang Hospital
name: Ming Shun Wu
role: STUDY_DIRECTOR
References:
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.