UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009139 |
|---|---|
| Receipt number | R000010713 |
| Scientific Title | Effects of Highly Absorptive Curcumin on Inflammation in Chronic Obstructive Pulmonary Disease (HS-Cur COPD study) |
| Date of disclosure of the study information | 2012/10/18 |
| Last modified on | 2017/04/24 00:05:06 |
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Basic information
Public title
Effects of Highly Absorptive Curcumin on
Inflammation in Chronic Obstructive Pulmonary Disease (HS-Cur COPD study)
Acronym
Effects of HS-Curcumin on COPD
Scientific Title
Effects of Highly Absorptive Curcumin on
Inflammation in Chronic Obstructive Pulmonary Disease (HS-Cur COPD study)
Scientific Title:Acronym
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
| 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, Fushimi-ku, 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 Medical Center
Division name
Division of Translational Research
Zip code
Address
1-1 Mukaihata-cho, Fukakusa, Fushimi-ku, 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
Theravalues Inc.
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
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 |
Related information
URL releasing protocol
Publication of results
Published
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
Main results already published
Date of protocol fixation
| 2012 | Year | 10 | Month | 15 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010713
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
