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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016493
Receipt No. R000019154
Scientific Title Comparison of bioavailability of curcuminoid-containing turmeric supplements after single oral administration in humans: a double-blind, four-way crossover study
Date of disclosure of the study information 2015/02/10
Last modified on 2016/03/09

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Basic information
Public title Comparison of bioavailability of curcuminoid-containing turmeric supplements after single oral administration in humans: a double-blind, four-way crossover study
Acronym Comparison of oral bioavailability of turmeric supplements in humans
Scientific Title Comparison of bioavailability of curcuminoid-containing turmeric supplements after single oral administration in humans: a double-blind, four-way crossover study
Scientific Title:Acronym Comparison of oral bioavailability of turmeric supplements in humans
Region
Japan

Condition
Condition Healthy subjects
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluation of oral bioavailability of turmeric supplements
Basic objectives2 Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Plasma concentrations of curcuminoids and related pharmacokinetics parameters
Key secondary outcomes Safety (biochemical examination of blood, medical examination by interview)

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Non-randomized
Randomization unit
Blinding Double blind -all involved are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 4
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Turmeric supplement 1
Single oral dose of the supplement containing about 30 mg of curcumin
Interventions/Control_2 Turmeric supplement 2
Single oral dose of the supplement containing about 300 mg of curcumin
Interventions/Control_3 Turmeric supplement 3
Single oral dose of the supplement containing about 30 mg of curcumin
Interventions/Control_4 Turmeric supplement 4
Single oral dose of the supplement containing about 40 mg of curcumin
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
45 years-old >=
Gender Male and Female
Key inclusion criteria Good general condition

Body weight <= 80 kg

20<=BMI<25
Key exclusion criteria Severe disease history

Food or drug allergy

Regular use or use within 2 weeks of turmeric-containing drugs or supplements
Target sample size 9

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Naoki Miura
Organization Miura Clinic
Division name Head of clinic
Zip code
Address 9F Higashitemma Bld., 1-7-17, Higashitemma, Kita-ku, Oosaka-shi, Osaka, 530-0044
TEL 06-6135-5200
Email miura@miura-cl.jp

Public contact
Name of contact person
1st name
Middle name
Last name Makoto Terashima
Organization Oneness Support Co., Ltd.
Division name Director
Zip code
Address 8F Higashitemma Bld., 1-7-17, Higashitemma, Kita-ku, Oosaka-shi, Osaka, 530-0044
TEL 06-4801-8917
Homepage URL
Email mterashima@oneness-sup.co.jp

Sponsor
Institute Health Evaluation Research Office
Kobe University Hospital
Institute
Department

Funding Source
Organization Association for Health Economics Research and Social Insurance and Welfare
Organization
Division
Category of Funding Organization Non profit foundation
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
2015 Year 02 Month 10 Day

Related information
URL releasing protocol
Publication of results Published

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
2015 Year 01 Month 26 Day
Date of IRB
Anticipated trial start date
2015 Year 02 Month 10 Day
Last follow-up date
2015 Year 03 Month 31 Day
Date of closure to data entry
2015 Year 03 Month 31 Day
Date trial data considered complete
2015 Year 06 Month 30 Day
Date analysis concluded
2015 Year 10 Month 31 Day

Other
Other related information

Management information
Registered date
2015 Year 02 Month 09 Day
Last modified on
2016 Year 03 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019154

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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