Unique ID issued by UMIN | UMIN000005500 |
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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 |
The efficacy of the healthy food containing an extract prepared from Actinidia arguta, in decreasing symptoms of pruritus in hemodialysis patients
The efficacy of an water soluble extract prepared from Actinidia arguta in hemodialysis patients with pruritus
The efficacy of the healthy food containing an extract prepared from Actinidia arguta, in decreasing symptoms of pruritus in hemodialysis patients
The efficacy of an water soluble extract prepared from Actinidia arguta in hemodialysis patients with pruritus
Japan |
pruritus in hemodialysis patients
Medicine in general | Nephrology | Dermatology |
Others
NO
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.
Safety,Efficacy
Exploratory
Pragmatic
Phase I,II
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)
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
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Food |
tablets contain an water soluble extract prepared from Actinidia arguta
20 | years-old | <= |
Not applicable |
Male and Female
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.)
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
10
1st name | |
Middle name | |
Last name | Arao Futenma |
Amano Memorial Clinic
Center for renal and collagen disease
4-3-6,Kaminagoya,Nishi-ku,Nagoya,Japan
+81-52-521-2788
1st name | |
Middle name | |
Last name | Yurina Ono |
Amano Memorial Clinic
Center for clinical trial supporting
4-3-6,Kaminagoya,Nishi-ku,Nagoya,Japan
+81-52-521-2788
Amano Memorial Clinic
SBI BIOTECH CO.
Profit organization
Japan
NO
天野記念クリニック(愛知県)
2011 | Year | 04 | Month | 25 | Day |
Unpublished
Completed
2011 | Year | 02 | Month | 28 | Day |
2011 | Year | 04 | Month | 01 | Day |
2011 | Year | 10 | Month | 01 | Day |
2011 | Year | 11 | Month | 01 | Day |
2011 | Year | 12 | Month | 01 | Day |
2012 | Year | 04 | Month | 01 | Day |
2011 | Year | 04 | Month | 24 | Day |
2012 | Year | 11 | Month | 10 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006522
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