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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007361
Receipt No. R000008671
Scientific Title Effects of Highly Absorptive Curcumin on Impaired Glucose Tolerance
Date of disclosure of the study information 2012/02/22
Last modified on 2019/02/26

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Basic information
Public title Effects of Highly Absorptive Curcumin on Impaired Glucose Tolerance
Acronym Curcumin on IGT
Scientific Title Effects of Highly Absorptive Curcumin on Impaired Glucose Tolerance
Scientific Title:Acronym Curcumin on IGT
Region
Japan

Condition
Condition IGT
Classification by specialty
Medicine in general Endocrinology and Metabolism Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 to determine the beneficial effects of high-absorption curcumin with DDS (drug-delivery system) (Theracurmin) in patients with impaired glucose tolerance
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes HbA1c
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
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 Treatment
Type of intervention
Food
Interventions/Control_1 High-absorption curcumin with DDS (Theracurmin, 1 capsule: 30 mg) at a fixed daily dose of 6 capsules/day.
Interventions/Control_2 Placebo at a fixed daily dose of 6 capsules/day.
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
80 years-old >
Gender Male and Female
Key inclusion criteria Patients with impaired glucose tolerance or type 2 diabetes, in whom HbA1c values between 6.3 and <8.4%
(No history of insulin treatment within 1 year before registration)
Key exclusion criteria 1) insulin therapy
2) renal insufficiency (Cre >= 4.0mg/dL) or hemodialysis
3) severe hepatic disorder or liver chirrosis
4) Unstable angina pectoris, acute myocardial infarction, severe coronary heart disease (left main trunk or triple vessel disease)
5) Shock, Heart failure, myocardila infarction, Pulmonary embolism
6) Stroke within 3 months
7) Severe ketosis, diabetic coma or pre-coma
9) Malneutrition
10) Malignancy
11) Anemia
12) Steroid use
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Koji Hasegawa
Organization National Hospital Organization Kyoto Medical Center
Division name Division of Translational Research
Zip code
Address 1-1 Mukaihata-cho, Fukakusa, Fusimi-ku, Kyoto
TEL 075-641-9161
Email koj@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Koji Hasegawa
Organization National Hospital Organization Kyoto Medical Center
Division name Division of Translational Research
Zip code
Address Division of Translational Research
TEL 075-641-9161
Homepage URL
Email koj@kuhp.kyoto-u.ac.jp

Sponsor
Institute National Hospital organization Kyoto Medical Center
Institute
Department

Funding Source
Organization Theravalues
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
2012 Year 02 Month 22 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
2011 Year 12 Month 13 Day
Date of IRB
Anticipated trial start date
2012 Year 02 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
2012 Year 02 Month 22 Day
Last modified on
2019 Year 02 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008671

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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