UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033774 |
|---|---|
| Receipt number | R000038523 |
| Scientific Title | Investigation of the effects of curcumin supplementation in patients with non-alcoholic fatty liver disease |
| Date of disclosure of the study information | 2018/11/22 |
| Last modified on | 2018/11/22 19:24:50 |
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Basic information
Public title
Investigation of the effects of curcumin supplementation in patients with non-alcoholic fatty liver disease
Acronym
Curcumin for fatty liver disease
Scientific Title
Investigation of the effects of curcumin supplementation in patients with non-alcoholic fatty liver disease
Scientific Title:Acronym
Curcumin for fatty liver disease
Region
| Asia(except Japan) |
Condition
Condition
Non-alcoholic fatty liver disease
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Effect of curcumin versus placebo on the severity of hepatic steatosis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Effect of curcumin versus placebo on the severity of hepatic steatosis
Key secondary outcomes
Effect of curcumin versus placebo on liver enzymes, lipids and glucose
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
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Curcuminoinds
Interventions/Control_2
placebo (lactose)
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
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Diagnosis of non-alcoholic fatty liver disease according to liver sonography
Key exclusion criteria
Pregnancy or breastfeeding
Hepatic
Malignancy
Hemochromatosis
Alcohol or opium abuse
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yunes Panahi |
Organization
Baqiyatallah University of Medical Sciences, Tehran, Iran
Division name
Pharmacotherapy Department
Zip code
Address
School of Pharmacy, Molla-Sadra st., Vanaq Sq., Tehran, Iran
TEL
+982182483393
yunespanahi@yahoo.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yunes Panahi |
Organization
Baqiyatallah University of Medical Sciences, Tehran, Iran
Division name
Pharmacotherapy Department
Zip code
Address
School of Pharmacy, Molla-Sadra st., Vanaq Sq., Tehran, Iran
TEL
+982182483393
Homepage URL
yunespanahi@yahoo.com
Sponsor or person
Institute
Baqiyatallah University of Medical Sciences, Tehran, Iran
Institute
Department
Personal name
Funding Source
Organization
Baqiyatallah University of Medical Sciences, Tehran, Iran
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Iran
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
| 2018 | Year | 11 | Month | 22 | 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
| 2017 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 06 | 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
| 2018 | Year | 08 | Month | 16 | Day |
Last modified on
| 2018 | Year | 11 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038523
