UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015490 |
|---|---|
| Receipt number | R000018001 |
| Scientific Title | Randomized double-blind study for the effect of highly absorption curcumin on volunteers with high levels of gamma-GTP |
| Date of disclosure of the study information | 2014/10/21 |
| Last modified on | 2025/05/07 17:43:18 |
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Basic information
Public title
Randomized double-blind study for the effect of highly absorption curcumin on volunteers with high levels of gamma-GTP
Acronym
Randomized double-blind study of highly absorption curcumin in volunteers with high levels of gamma-GTP
Scientific Title
Randomized double-blind study for the effect of highly absorption curcumin on volunteers with high levels of gamma-GTP
Scientific Title:Acronym
Randomized double-blind study of highly absorption curcumin in volunteers with high levels of gamma-GTP
Region
| Japan |
Condition
Condition
Healthy volunteers with high or moderate level of gamma-GTP
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine whether highly absorption curcumin dose-dependently improves gamma-GTP level in healthy volunteers with high or moderate level of gamma-GTP
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Evaluation of gamma-GTP level by blood examination
Key secondary outcomes
1) Evaluation of blood pressure
2) Hematological and biochemical evaluation by blood examination
3 Measurement of curcumin level in blood
4) Others, adverse events
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Highly absorption curcumin 180 mg/day for 12 weeks
Interventions/Control_2
Highly absorption curcumin 60 mg/day for 12 weeks
Interventions/Control_3
placebo for 12 weeks
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy volunteers with gamma-GTP level from standard value to upper limit - 200(IU/L) at the time of study entry
Key exclusion criteria
1) Cirrhosis or liver cancer
2) Occlusive jaundice or hepatic bile congestion
3) Use of antiplatelet
4) Pregnancy, nursing, or a wish of pregnancy within next 6 months
5) The person who participates in other clinical trials at the time of this study entry
6) etc
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tatsuya Morimoto |
Organization
Shizuoka Prefectural General Hospital
Division name
Department of Cardiovascular Clinical Pharmacology, Clinical Research Institue
Zip code
Address
1-27-4, Kita-ando, Aoi-ku, Shizuoka-shi, Shizuoka 420-8527
TEL
054-247-6111
morimoto@u-shizuoka-ken.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tatsuya Morimoto |
Organization
Shizuoka Prefectural General Hospital
Division name
Department of Cardiovascular Clinical Pharmacology, Clinical Research Institue
Zip code
Address
4-27-1, Kita-ando, Aoi-ku, Shizuoka-shi, Shizuoka 420-8527
TEL
054-247-6111
Homepage URL
morimoto@u-shizuoka-ken.ac.jp
Sponsor or person
Institute
Shizuoka Prefectural General Hospital
Institute
Department
Personal name
Funding Source
Organization
Theravalues corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
KYORIN Pharmaceutical Co
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
静岡県立総合病院
聖隷健康サポートセンター
SBS静岡健康増進センター
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 10 | Month | 21 | 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
Completed
Date of protocol fixation
| 2014 | Year | 08 | Month | 11 | Day |
Date of IRB
| 2014 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2014 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 10 | Month | 21 | Day |
Last modified on
| 2025 | Year | 05 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018001
