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


Email



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


Email



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


Email



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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name