UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012826 |
|---|---|
| Receipt number | 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 15:26:13 |
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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 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
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
ymizuno@jmks-med.or.jp
Sponsor or person
Institute
Chuou Naika Clinic
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014881
