UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A clinical trial about improvement effect of Chrysanthemum Morifolium Flower extract supplementation on serum uric acid value
Title of the study (Brief title)	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	Hiroshi Shimoda
Organization	Oryza Oil & Fat Chemical Co., LTD.
Division name	R & D center
Address	1 Numata Kitagata Kitagata-cho, Ichinomiya City,Aichi Pref.
TEL	0586865141
Email	kaihatsu@mri.biglobe.ne.jp

Public contact
Name of contact person	Shogo Takeda
Organization	Oryza Oil & Fat Chemical Co., LTD.
Division name	Food Development Dept., R & D Center
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 05 Month 11 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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