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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005500
Receipt No. 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

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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
Institute Amano Memorial Clinic
Institute
Department

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
URL(English) https://upload.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


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