UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of High-absorptive Curcumin on Oxidative Stress Caused by Smoking
Title of the study (Brief title)	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	Koji Hasegawa
Organization	National Hospital Organization Kyoto Medical Center
Division name	Division of Translational Research
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	Koji Hasegawa
Organization	National Hospital Organization Kyoto
Division name	Division of Translational Research
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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2010 Year 06 Month 09 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000004641