UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Influence of Water Soluble Silicon for Fatty Liver Combined with Lifestyle Related Disease
Title of the study (Brief title)	Effect of water-soluble silicon for fatty liver
Region	Japan

Condition
Condition	Lifestyle-related disease Combined fatty liver
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effect of water-soluble silicon in fatty liver combined with lifestyle-related disease.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Blood pressure measurement, physical measurement, general blood test, blood biochemical test, abdominal ultrasonography, fibrosis marker test, inflammatory marker test, oxidative stress type marker test, adipocytokine type marker test, questionnaire
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Single blind -participants are blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Approximately 9 ml of water-soluble silicon is drunk for 6 months per day. Diet therapy is also done for drinking intake group.
Interventions/Control_2	For non-ingesting group, do not drink it but do only usual diet therapy.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who satisfy any of the following items are targeted. 1: outpatient with lifestyle-related disease 2: Patients complicated with metabolic syndrome 3: Patients complicated with nonmetabolic syndrome and judged as fatty liver by image diagnosis 4: Patients with fatty liver whose other liver injury was denied
Key exclusion criteria	Exclude any person who falls under any of the following. 1 Viral hepatitis and liver cirrhosis 2 serious liver dysfunction (liver function test value is more than 3 times normal upper limit) 3 heart failure 4 Severe ketosis or Diabetic coma Type 1 diabetes 5 severe renal dysfunction 6 Severe infection or Patients before and after surgery 7 Patients with a history of hypersensitivity to water-soluble silicon 8 Patients who may be pregnant or pregnant 9 Patients with metabolic liver disease 10 Patients with autoimmune liver disease 11 Patients with cirrhosis /due to causes other than 1 12 When the consent of the patient can not be obtained 13 Case in which the doctor approved inappropriate for participation in the study
Target sample size	30

Research contact person
Name of lead principal investigator	Yoshitaka Fukuzawa
Organization	Aichi Medical University Hospital
Division name	Preemptive and Integrative Medicine Center
Address	Karimata 1-1, Yazako, Nagakute city, Aichi Prefecture
TEL	0561-62-3311
Email	yofuku@aichi-med-u.ac.jp

Public contact
Name of contact person	Yoshitaka Fukuzawa
Organization	Aichi Medical University Hospital
Division name	Preemptive and Integrative Medicine Center
Address	Karimata 1-1, Yazako, Nagakute City, Aichi Prefecture
TEL	0561-62-3311
Homepage URL
Email	yofuku@aichi-med-u.ac.jp

Sponsor
Institute	Aichi Medical University Hospital
Institute
Department

Funding Source
Organization	Aichi Medical University Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2018 Year 02 Month 23 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 02 Month 23 Day
Anticipated trial start date	2018 Year 02 Month 23 Day
Last follow-up date	2019 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 02 Month 23 Day
Last modified on	2019 Year 02 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035478