UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000012826
Receipt No. R000014881
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 2014/01/12
Last modified on 2014/01/11

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 ECP(Eosinophilic cathionic protein) and symptoms of pruritus.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase 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 Parallel
Randomization Randomized
Randomization unit Individual
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
Food
Interventions/Control_1 tablets contain an water soluble extract prepared from Actinidia arguta
Interventions/Control_2 placebo
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
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 scheduled to commence of Nalfurafine Hydrochloride and/or Antihistamic drug of int. the study.
11, Patients who are unsuitable to the study at a physician's discretion
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshie Kusano
Organization Chuou Naika Clinic
Division name Internal Medicine
Zip code
Address 1-4-40 Hiroekimae, Kure, Japan
TEL 81-823-71-8585
Email rdimmuno-group@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yurina Ono
Organization 2014 PG3S Secretariat (c/o Amano Kinen Clinic)
Division name Secretariat
Zip code
Address 4-3-6, Kaminagoya, Nishi-ku, Nagoya
TEL 81525212788
Homepage URL
Email ymizuno@jmks-med.or.jp

Sponsor
Institute Chuou Naika Clinic
Institute
Department

Funding Source
Organization SBI Biotech Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
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
2014 Year 01 Month 12 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 Enrolling by invitation
Date of protocol fixation
2013 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 01 Month 13 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
2014 Year 01 Month 11 Day
Last modified on
2014 Year 01 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014881

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.