UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of Highly Absorptive Curcumin on Inflammation in Chronic Obstructive Pulmonary Disease (HS-Cur COPD study)
Title of the study (Brief title)	Effects of HS-Curcumin on COPD
Region	Japan

Condition
Condition	Mild or moderate chronic obstructive pulmonary disease
Classification by specialty	Medicine in general Pneumology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to determine the effects of high-absorption curcumin with DDS (drug-delivery system) (Theracurmin) on inflammatory markers in patients with mild or moderate chronic obstructive pulmonary disease.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Serum levels of inflammatory biomarkers such as IL-6, hsCRP, SAA-LDL
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	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Three capsules (1 capsule: 30 mg) of high-absorption curcumin capsule (Theracurmin) are orally administered twice daily (after breakfast and dinner, respectively) for 24 weeks.
Interventions/Control_2	Three capsules (1 capsule: 30 mg) of placebo capsule are orally administered twice daily (after breakfast and dinner, respectively) for 24 weeks.
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	85 years-old >
Gender	Male and Female
Key inclusion criteria	1) Patients with chronic obstructive pulmonary disease at stage 0, I, or II according to the definition by the Japanese Respiratory Society 2) Patients who have never smoked at least for the past 4 months
Key exclusion criteria	1) severe lung diseases other than COPD 2) renal insufficiency (Cre >= 4.0mg/dL) or hemodialysis 3) severe hepatic disorder or liver cirrhosis 4) Unstable angina pectoris, acute myocardial infarction, severe coronary heart disease (left main trunk or triple vessel disease) 5) Shock, Heart failure, myocardial infarction, Pulmonary embolism 6) Stroke within 3 months 7) Uncontrolled diabetes (more than 10% of HbA1c) 8) Severe infection or trauma 9) Malnutrition 10) Malignancy 11) Anemia (less than 6 mg/dL of Hb) 12) Use of steroid or antibiotics 13) Intake of curcumin 14) Allergy 15) Pregnancy 16) etc
Target sample size	60

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, Fushimi-ku, 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 Medical Center
Division name	Division of Translational Research
Address	1-1 Mukaihata-cho, Fukakusa, Fushimi-ku, 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	Theravalues Inc.
Organization
Division
Category of Funding Organization	Profit organization
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	2012 Year 10 Month 18 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2012 Year 10 Month 15 Day
Anticipated trial start date	2012 Year 10 Month 18 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	Published
URL releasing results
Results
Other related information

Management information
Registered date	2012 Year 10 Month 18 Day
Last modified on	2017 Year 04 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000010713