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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023663
Receipt No. R000027258
Scientific Title Effect of ingestion of trial supplement on serum uric acid level -A double blind, placebo controlled study-
Date of disclosure of the study information 2016/08/19
Last modified on 2017/01/23

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Basic information
Public title Effect of ingestion of trial supplement on serum uric acid level -A double blind, placebo controlled study-
Acronym Effect of ingestion of trial supplement on serum uric acid level
Scientific Title Effect of ingestion of trial supplement on serum uric acid level -A double blind, placebo controlled study-
Scientific Title:Acronym Effect of ingestion of trial supplement on serum uric acid level
Region
Japan

Condition
Condition Healthy male subject
Classification by specialty
Adult
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 This study is aimed to verify improvement effect of trial supplement on serum uric acid level.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Serum uric acid level
Key secondary outcomes Urine uric acid level
Subgroup analysis using SNP
Relationship among serum uric acid, urine uric acid, and SNP

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 4
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Ingestion of trial supplement A for 4 weeks
Interventions/Control_2 Ingestion of trial supplement B for 4 weeks
Interventions/Control_3 Ingestion of trial supplement C for 4 weeks
Interventions/Control_4 Ingestion of placebo for 4 weeks
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
65 years-old >
Gender Male
Key inclusion criteria 1) Japanese males aged from 20 to less than 65 years old.
2) Subjects whose serum uric acid levels are included within 6.0mg/dL and 8.0mg/dL.
Key exclusion criteria 1) Subjects who are under treatment or have a history of hyperuricemia or gout.
2) Subjects who have a history of gouty arthritis or gouty arthritis.
3) Subjects who are under treatment or have a history of rheumatoid arthritis.
4) Subjects who have a history of urinary stone or kidney stone.
5) Subjects who has a disease under treatment or are judged to that medical treatment are necessary by the doctor
6) Subjects who have under treatment or history of disease such as diabetes, liver disease, kidney disease, heart disease, adrenal cortex disease.
7) Subjects who are routinely use the health food, dietary supplement, and medicine including over-the-counter drug for improving of serum uric acid.
8) Subjects who routinely use or are planned to use analgesics (non-steroidal analgesics, steroidal analgesics, etc.).
9) Subjects with allergies to the products used in the study.
10) Subjects who are planned to change their lifestyle.
11) Subjects who have participated in other clinical study within the last one month prior to the current study
12) Subjects who are judged as unsuitable for the study by the investigator for other reason
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kumie Ito
Organization Nihonbashi Sakura Clinic
Division name Assistant director
Zip code
Address 5F,Inamura Building,1-9-2, Nihonbashikayabacho,Chuo-ku, Tokyo, Japan
TEL 03-6661-9061
Email k-ito@ouryokukai.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshiki Shimizu
Organization FANCL CORPORATION
Division name Research institute
Zip code
Address Kamishinano 12-13, Totsuka-ku, Yokohama, Kanagawa, Japan
TEL 045-820-3755
Homepage URL
Email shimizu_yoshiki@fancl.co.jp

Sponsor
Institute FANCL Corporation
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

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 医療法人社団桜緑会 日本橋さくらクリニック

Other administrative information
Date of disclosure of the study information
2016 Year 08 Month 19 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
2016 Year 08 Month 17 Day
Date of IRB
Anticipated trial start date
2016 Year 08 Month 21 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 08 Month 18 Day
Last modified on
2017 Year 01 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027258

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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