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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000003853
Receipt No. R000004641
Scientific Title Effects of High-absorptive Curcumin on Oxidative Stress Caused by Smoking
Date of disclosure of the study information 2010/07/01
Last modified on 2017/07/06

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Basic information
Public title Effects of High-absorptive Curcumin on Oxidative Stress Caused by Smoking
Acronym Effect of Curcumin on Oxidative Stress
Scientific Title Effects of High-absorptive Curcumin on Oxidative Stress Caused by Smoking
Scientific Title:Acronym Effect of Curcumin on Oxidative Stress
Region
Japan

Condition
Condition Smoker
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effect of high-absorptive curcumin on oxidative stress caused by smoking
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Serum levels of oxidative stress markers
Key secondary outcomes Serum levels of possible novel biomarkers of cardiovascular risk

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 High-absorptive Curcumin 30mg/day
po for 12 weeks
Interventions/Control_2
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 1. Smokers who tried to but could not quit smoking after standard smoking cessation program at Smoking Cessation Clinic.

2. Smokers who will not quit smoking.
Key exclusion criteria 1) Unstable angina, recent (< 3 months)
myocardial infarction, severe coronary
heart disease (left main trunk or 3 vessel disease), and recent (=< 3 months) orplanned (=< 6 months) AC bypass
surgery / PCI
2) Severe arrhythmia (sustained
ventricular tachycardia, ventricular
fibrillation, and severe bradycardia with
an indication of pacemaker implantation
3) Moderate or severe valvular diseases
4) Cardiomyopathy or progressive
myocarditis
5) Severe respiratory diseases
6) Cardiogenic shock or systolic blood
pressure < 80 mmHg
7) Renal failure (Cre >= 4.0 mg/dL or
dialysis)
8) Severe liver dysfunction or liver
cirrhosis
9) Recent (< 3 months) cerebrovascular
disease
10) Malignancy
11) Poorly controlled diabetes (HbA1c >=
8.0%)
12) Anemia (Hb < 6.0 mg/dL)
13) Use of steroid
14) Past history of Curcumin allergy
15) Pregnancy, nursing, or a wish for
pregnancy within 6 months
16) etc
Target sample size 30

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, Fushimiku, Kyoto, Japan
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
Division name Division of Translational Research
Zip code
Address 1-1 Mukaihata-cho, Fukakusa, Fushimiku, Kyoto, Japan
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 The Japan Health Sciences Foundation
Organization
Division
Category of Funding Organization Other
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
2010 Year 07 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 Terminated
Date of protocol fixation
2010 Year 06 Month 09 Day
Date of IRB
Anticipated trial start date
2010 Year 07 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
2010 Year 07 Month 01 Day
Last modified on
2017 Year 07 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004641

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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