UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000005500
Receipt number R000006522
Scientific Title The efficacy of the healthy food containing an extract prepared from Actinidia arguta, in decreasing symptoms of pruritus in hemodialysis patients
Date of disclosure of the study information 2011/04/25
Last modified on 2012/11/10 09:18:44

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Basic information

Public title

The efficacy of the healthy food containing an extract prepared from Actinidia arguta, in decreasing symptoms of pruritus in hemodialysis patients

Acronym

The efficacy of an water soluble extract prepared from Actinidia arguta in hemodialysis patients with pruritus

Scientific Title

The efficacy of the healthy food containing an extract prepared from Actinidia arguta, in decreasing symptoms of pruritus in hemodialysis patients

Scientific Title:Acronym

The efficacy of an water soluble extract prepared from Actinidia arguta in hemodialysis patients with pruritus

Region

Japan


Condition

Condition

pruritus in hemodialysis patients

Classification by specialty

Medicine in general Nephrology Dermatology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the effect of tablets contain an water soluble extract prepared from Actinidia arguta on the decrease of the level of risk factors for allergy such as IgE and symptoms of pruritus.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase I,II


Assessment

Primary outcomes

1, Evaluate the effect in decreasing symptoms of pruritus measured by VAS(Visual analogue scale).
2, Changes in the level of IgE in the blood
3, Changes in the number of eosinophils in the blood
4, Changes in the level of ECP (Eosinophil Cationic Protein)

Key secondary outcomes

1, Changes in the level of phosphorus and potassium
2, Changes in the level of intact-PTH
3, Changes in the value of blood test and urine test


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

tablets contain an water soluble extract prepared from Actinidia arguta

Interventions/Control_2


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, Age: Men and women 20 years old and older
2, Hemodialysis patients with symptomatic pruritus
3, Patients who don't need assist from others in their daily life
4, Level of IgE in the blood: 50 IU/ml and over
5, Patients who haven't had benefit of existing treatments for pruritus (antohistamin drug, steroid, etc.)

Key exclusion criteria

1, Level of IgE in the blood: under 50 IU/mL
2, Patients with i-PTH of 500pg/ml and above in the past one month.
3, Patients who had parathyroidectomy in the past 6 months of int the study
4, Patients with allergy to kiwi fruits
5, Patients in asthma care.
6, Patients in the cancer treatment
7, Patients with a history of kidney transplant
8, Patients who are pregnant or to be pregnant within three months
9, Patients with severe mental disorder
10, Patients who are unsuitable to the study at a physician's discretion

Target sample size

10


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Arao Futenma

Organization

Amano Memorial Clinic

Division name

Center for renal and collagen disease

Zip code


Address

4-3-6,Kaminagoya,Nishi-ku,Nagoya,Japan

TEL

+81-52-521-2788

Email



Public contact

Name of contact person

1st name
Middle name
Last name Yurina Ono

Organization

Amano Memorial Clinic

Division name

Center for clinical trial supporting

Zip code


Address

4-3-6,Kaminagoya,Nishi-ku,Nagoya,Japan

TEL

+81-52-521-2788

Homepage URL


Email



Sponsor or person

Institute

Amano Memorial Clinic

Institute

Department

Personal name



Funding Source

Organization

SBI BIOTECH CO.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan


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

天野記念クリニック(愛知県)


Other administrative information

Date of disclosure of the study information

2011 Year 04 Month 25 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

2011 Year 02 Month 28 Day

Date of IRB


Anticipated trial start date

2011 Year 04 Month 01 Day

Last follow-up date

2011 Year 10 Month 01 Day

Date of closure to data entry

2011 Year 11 Month 01 Day

Date trial data considered complete

2011 Year 12 Month 01 Day

Date analysis concluded

2012 Year 04 Month 01 Day


Other

Other related information



Management information

Registered date

2011 Year 04 Month 24 Day

Last modified on

2012 Year 11 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006522


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name