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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04718051
Recruitment Status : Recruiting
First Posted : January 22, 2021
Last Update Posted : January 22, 2021
Sponsor:
Collaborator:
Sheng Pu Pharmaceutics Co., Ltd.
Information provided by (Responsible Party):
Taipei Medical University WanFang Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Liver Diseases Drug: Shen Pu Yang Gan Wan Drug: Placebo Phase 4

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: S.P.PRO LIVER POWDER is Used to Improve Liver and Metabolic Indexes in People With Non-alcoholic Fatty Liver Disease
Actual Study Start Date : January 13, 2021
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Shen Pu Yang Gan Wan
Traditional Chinese Medicine
 Drug: Shen Pu Yang Gan Wan
Shen Pu Yang Gan Wan is Traditional Chinese Medicine; in addition, it has a high dose.
Placebo Comparator: Placebo Comparator
Placebo Comparator
 Drug: Placebo
Shen Pu Yang Gan Wan is Traditional Chinese Medicine; however, it has a very low dose.


Outcome Measures
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Primary Outcome Measures :
  1. Change in AST index [ Time Frame: 36 weeks ]
    Measure the changes in the index which is AST relate to Liver inflammation

  2. Change in ACT index [ Time Frame: 36 weeks ]
    Measure the changes in the index which is ACT relate to Liver inflammation

  3. Change in HbA1c [ Time Frame: 36 weeks ]
    Measure the changes in the index which is HbA1c relate to Liver inflammation

  4. Fibroscan [ Time Frame: 36 weeks ]
    Measure the changes in the index which is Liver Fibrosis


Secondary Outcome Measures :
  1. Measuring Body Mass Index [ Time Frame: 36 weeks ]
    Measuring Body Mass Index (BMI). Measure the changes in index which is Metabolism


Eligibility Criteria
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Ages Eligible for Study:   35 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04718051


Contacts
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Contact: Ming Shun Wu, PHD +886229307930 vw1017@gmail.com

Locations
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Taiwan
Wanfang Hospital Recruiting
Taipei, Wenshan District, Taiwan, 116
Contact: Ming Shun Wu    0229307930 ext 1248    mswu@tmu.edu.tw   
Sponsors and Collaborators
Taipei Medical University WanFang Hospital
Sheng Pu Pharmaceutics Co., Ltd.
Investigators
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Study Director: Ming Shun Wu Taipei Municipal Wanfang Hospital
More Information
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Publications:

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Responsible Party: Taipei Medical University WanFang Hospital
ClinicalTrials.gov Identifier: NCT04718051    
Other Study ID Numbers: N202007032
First Posted: January 22, 2021    Key Record Dates
Last Update Posted: January 22, 2021
Last Verified: December 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Digestive System Diseases