UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031436 |
|---|---|
| Receipt number | 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 22:47:21 |
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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
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
yofuku@aichi-med-u.ac.jp
Sponsor or person
Institute
Aichi Medical University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035478
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
