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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023818
Receipt No. R000027435
Scientific Title A clinical trial about improvement effect of Chrysanthemum Morifolium Flower extract supplementation on serum uric acid value
Date of disclosure of the study information 2016/12/01
Last modified on 2017/01/19

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Basic information
Public title A clinical trial about improvement effect of Chrysanthemum Morifolium Flower extract supplementation on serum uric acid value
Acronym A clinical trial about improvement effect of Chrysanthemum Morifolium Flower extract supplementation on serum uric acid value
Scientific Title A clinical trial about improvement effect of Chrysanthemum Morifolium Flower extract supplementation on serum uric acid value
Scientific Title:Acronym A clinical trial about improvement effect of Chrysanthemum Morifolium Flower extract supplementation on serum uric acid value
Region
Japan

Condition
Condition Healthy male subjects
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the inhibitory efficacy and safety for oral intake of Chrysanthemun Morifolium Flower Extract on serum uric acid value
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Serum uric acid value
Key secondary outcomes CRP value, erythrocyte sedimentation rate, leukocyte count, urine pH, body height, Body weight, BMI, systolic blood pressure and diastolic blood pressure

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Cluster
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 100mg/day of Chrysanthemum Morifolium Flower Extract supplementation for 4 weeks. washout for 2 weeks, 100mg/day of placebo supplementation for 4 weeks
Interventions/Control_2 100mg/day of placebo supplementation for 4 weeks, washout for 2 weeks, 100mg/day of Chrysanthemum Morifolium Flower Extract supplementation for 4 weeks
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 Healthy male subjects with serum uric acid value under 7.9 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 30

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 R & D center
Zip code
Address 1 Numata Kitagata Kitagata-cho, Ichinomiya City,Aichi Pref.
TEL 0586865141
Email kaihatsu@mri.biglobe.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shogo Takeda
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 0586865141
Homepage URL
Email kaihatsu@mri.biglobe.ne.jp

Sponsor
Institute Oryza Oil & Fat Chemical Co., LTD.
Institute
Department

Funding Source
Organization Oryza Oil & Fat Chemical Co., LTD.
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
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
2016 Year 12 Month 01 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 09 Month 06 Day
Last follow-up date
2016 Year 11 Month 15 Day
Date of closure to data entry
2016 Year 11 Month 20 Day
Date trial data considered complete
2016 Year 12 Month 01 Day
Date analysis concluded
2016 Year 12 Month 07 Day

Other
Other related information

Management information
Registered date
2016 Year 08 Month 29 Day
Last modified on
2017 Year 01 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027435

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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