UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000031436
Receipt No. R000035478
Scientific Title Influence of Water Soluble Silicon for Fatty Liver Combined with Lifestyle Related Disease
Date of disclosure of the study information 2018/02/23
Last modified on 2019/02/23

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Influence of Water Soluble Silicon for Fatty Liver Combined with Lifestyle Related Disease
Acronym Effect of water-soluble silicon for fatty liver
Scientific Title Influence of Water Soluble Silicon for Fatty Liver Combined with Lifestyle Related Disease
Scientific Title:Acronym 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
1st name
Middle name
Last name Yoshitaka Fukuzawa
Organization Aichi Medical University Hospital
Division name Preemptive and Integrative Medicine Center
Zip code
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
1st name
Middle name
Last name Yoshitaka Fukuzawa
Organization Aichi Medical University Hospital
Division name Preemptive and Integrative Medicine Center
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2018 Year 02 Month 23 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.