UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022823 |
|---|---|
| Receipt number | R000026305 |
| Scientific Title | A study to evaluate the inhibitory effect of Chrysanthemum Morifolium Flower Extract containing supplement on diet-induced serum uric acid elevation in healthy male subjects |
| Date of disclosure of the study information | 2016/07/30 |
| Last modified on | 2016/08/29 14:37:20 |
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Basic information
Public title
A study to evaluate the inhibitory effect of Chrysanthemum Morifolium Flower Extract containing supplement on diet-induced serum uric acid elevation in healthy male subjects
Acronym
A study to evaluate the inhibitory effect of Chrysanthemum Morifolium Flower Extract containing supplement on serum uric acid
Scientific Title
A study to evaluate the inhibitory effect of Chrysanthemum Morifolium Flower Extract containing supplement on diet-induced serum uric acid elevation in healthy male subjects
Scientific Title:Acronym
A study to evaluate the inhibitory effect of Chrysanthemum Morifolium Flower Extract containing supplement on serum uric acid
Region
| Japan |
Condition
Condition
Healthy male volunteers, mild hyperuricemia
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the inhibitory effect of Chrysanthemum Morifolium Flower Extract containing supplement on serum uric acid
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Serum uric acid level
Key secondary outcomes
Urine uric acid level
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Chrysanthemum Morifolium Flower containing supplement
Interventions/Control_2
Chrysanthemum Morifolium Flower non-containing supplement
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
| 70 | years-old | >= |
Gender
Male
Key inclusion criteria
Serum uric acid 5.5-8.0 mg/dL
Key exclusion criteria
1) Taking anti-hyperuricemic drugs
2) History of gouty arthritis, gouty node, and/or gouty attack
3) Taking drugs or functional food that may affect serum uric acid level
4) Participation in any clinical trial within 90 days of the commencement of the trial
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Shimoda |
Organization
Oryza Oil & Fat Chemical Co., LTD.
Division name
Food Development Dept., R & D Center
Zip code
Address
1 Numata Kitagata Kitagata-cho, Ichinomiya City,Aichi Pref.
TEL
0586-86-5141
kaihatsu@mri.biglobe.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shoketsu Hitoe |
Organization
Oryza Oil & Fat Chemical Co., LTD.
Division name
Food Development Dept., R & D Center
Zip code
Address
1 Numata Kitagata Kitagata-cho, Ichinomiya City,Aichi Pref.
TEL
0586-86-5141
Homepage URL
kaihatsu@mri.biglobe.ne.jp
Sponsor or person
Institute
Oryza Oil & Fat Chemical Co., LTD.
Institute
Department
Personal name
Funding Source
Organization
Food Development Dept., R & D Center
Organization
Division
Category of Funding Organization
Profit organization
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
| 2016 | Year | 07 | Month | 30 | 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 | 05 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 06 | Month | 23 | Day |
Last follow-up date
| 2016 | Year | 07 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 06 | Month | 21 | Day |
Last modified on
| 2016 | Year | 08 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026305
| 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 |
