UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022775
Receipt number R000026246
Scientific Title Effect of coadministration of ume paste (Prunus mume) and ginger powder on serum uric acid level
Date of disclosure of the study information 2016/06/20
Last modified on 2018/12/20 14:54:19

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Basic information

Public title

Effect of coadministration of ume paste (Prunus mume) and ginger powder on serum uric acid level

Acronym

Effect of coadministration of ume paste (Prunus mume) and ginger powder on serum uric acid level

Scientific Title

Effect of coadministration of ume paste (Prunus mume) and ginger powder on serum uric acid level

Scientific Title:Acronym

Effect of coadministration of ume paste (Prunus mume) and ginger powder on serum uric acid level

Region

Japan


Condition

Condition

Healthy volunteers, mild hyperuricemia

Classification by specialty

Medicine in general Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To determine the effect of coadministration of ume paste and ginger powder on serum uric acid level.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

Serum uric acid level at baseline, 4, 8, and 12 weeks.

Key secondary outcomes

Uric acid clearance and urinary pH at baseline, 4, 8, and 12 weeks.
Platelet aggregation test, thromboxane B2, and MDA (malondialdehyde) levels at baseline and 12 weeks.


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

YES

Dynamic allocation

NO

Institution consideration


Blocking

YES

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Subjects receive 4 capsules (1200 mg)/day containing ume paste and ginger powder for 12 weeks.

Interventions/Control_2

Subjects receive 4 placebo capsules (1200 mg)/day for 12 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

Serum uric acid 6.0-7.9 mg/dL

Key exclusion criteria

1) Taking anti-hyperuricemic drugs
2) History of gouty arthritis, gouty node, and/or gouty attack
3) Taking medicines or receiving health guidance for hypertension, diabetes, hyperlipidemia, and/or metabolic syndrome
4) Taking drugs or functional food that may affect serum uric acid level
5) Participation in any clinical trial within 90 days of the commencement of the trial
6) CKD stage >=A2 and/or >=G3a
7) History of severe disease and/or major surgery
8) Judged as ineligible by clinical investigators.

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Fumiko Higashikawa

Organization

Hiroshima University, Institute of Biomedical & Health Sciences

Division name

Project Research Center for Clinical Trial and Preventive Medicine

Zip code


Address

Kasumi 1-2-3, Minami-ku, Hiroshima 734-8551, JAPAN

TEL

082-257-1533

Email

fumiko@hiroshima-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Fumiko Higashikawa

Organization

Hiroshima University, Institute of Biomedical & Health Sciences

Division name

Project Research Center for Clinical Trial and Preventive Medicine

Zip code


Address

Kasumi 1-2-3, Minami-ku, Hiroshima 734-8551, JAPAN

TEL

082-257-1533

Homepage URL


Email

fumiko@hiroshima-u.ac.jp


Sponsor or person

Institute

Hiroshima University

Institute

Department

Personal name



Funding Source

Organization

KAWAMOTO FOODS 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 06 Month 20 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 06 Month 15 Day

Date of IRB


Anticipated trial start date

2016 Year 08 Month 01 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 06 Month 17 Day

Last modified on

2018 Year 12 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026246


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name