UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003853 |
|---|---|
| Receipt number | 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 15:40:01 |
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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
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
koj@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
National Hospital Organization Kyoto
Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004641
