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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000033774
Receipt No. R000038523
Official scientific title of the study 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

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Basic information
Official scientific title of the study Investigation of the effects of curcumin supplementation in patients with non-alcoholic fatty liver disease
Title of the study (Brief title) 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 Yunes Panahi
Organization Baqiyatallah University of Medical Sciences, Tehran, Iran
Division name Pharmacotherapy Department
Address School of Pharmacy, Molla-Sadra st., Vanaq Sq., Tehran, Iran
TEL +982182483393
Email yunespanahi@yahoo.com

Public contact
Name of contact person Yunes Panahi
Organization Baqiyatallah University of Medical Sciences, Tehran, Iran
Division name Pharmacotherapy Department
Address School of Pharmacy, Molla-Sadra st., Vanaq Sq., Tehran, Iran
TEL +982182483393
Homepage URL
Email yunespanahi@yahoo.com

Sponsor
Institute Baqiyatallah University of Medical Sciences, Tehran, Iran
Institute
Department

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)

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

Progress
Recruitment status Completed
Date of protocol fixation
2017 Year 04 Month 01 Day
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

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038523

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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