Liver Diseases
Conditions
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.
Interventions
DRUGShen Pu Yang Gan Wan
Shen Pu Yang Gan Wan is Traditional Chinese Medicine; in addition, it has a high dose.
DRUGPlacebo
Shen Pu Yang Gan Wan is Traditional Chinese Medicine; however, it has a very low dose.
Sponsors
Sheng Pu Pharmaceutics Co., Ltd.
Taipei Medical University WanFang Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
35 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in AST index | 36 weeks | Measure the changes in the index which is AST relate to Liver inflammation |
| Change in ACT index | 36 weeks | Measure the changes in the index which is ACT relate to Liver inflammation |
| Change in HbA1c | 36 weeks | Measure the changes in the index which is HbA1c relate to Liver inflammation |
| Fibroscan | 36 weeks | Measure the changes in the index which is Liver Fibrosis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Measuring Body Mass Index | 36 weeks | Measuring Body Mass Index (BMI). Measure the changes in index which is Metabolism |
Countries
Taiwan
Contacts
Primary ContactMing Shun Wu, PHD
Outcome results
None listed