UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007015 |
|---|---|
| Receipt number | R000007820 |
| Scientific Title | Placebo-controlled double blind study of the efficacy of Curcumin in patients with NAFLD/NASH |
| Date of disclosure of the study information | 2012/01/04 |
| Last modified on | 2012/01/04 19:46:51 |
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Basic information
Public title
Placebo-controlled double blind study of the efficacy of Curcumin in patients with NAFLD/NASH
Acronym
Placebo-controlled double blind study of the efficacy of Curcumin in patients with NAFLD/NASH
Scientific Title
Placebo-controlled double blind study of the efficacy of Curcumin in patients with NAFLD/NASH
Scientific Title:Acronym
Placebo-controlled double blind study of the efficacy of Curcumin in patients with NAFLD/NASH
Region
| Japan |
Condition
Condition
NAFLD/NASH
Classification by specialty
| Medicine in general | Gastroenterology | Hepato-biliary-pancreatic medicine |
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To evaluate safety and efficacy of Curcumin
by Placebo-controlled double blind study in patients with NAFLD/NASH.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The efficacy of Curcumin in patients with NAFLD/NASH.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Curcumin/Placebo
Interventions/Control_2
Placebo/Curcumin
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.patients diagnosed as NAFLD/NASH
2.PS0-2
3.patients being consent to this study.
Key exclusion criteria
1.patients having other severe complications.
2.patients incapable of oral intake.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Marusawa |
Organization
Graduate School of Medicine, Kyoto University
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
Shogoin-Kawaharacho 54, Sakyo-ku, Kyoto, Japan.
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Graduate School of Medicine, Kyoto University
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Department of Gastroenterology and Hepatology, Graduate School of Medicine, Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Department of Gastroenterology and Hepatology, Graduate School of Medicine, Kyoto University
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
| 2012 | Year | 01 | Month | 04 | 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
Preinitiation
Date of protocol fixation
| 2011 | Year | 12 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 01 | 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
| 2012 | Year | 01 | Month | 04 | Day |
Last modified on
| 2012 | Year | 01 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007820
