Unique ID issued by UMIN | UMIN000007694 |
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Receipt number | R000009074 |
Scientific Title | The randomized controlled clinical trial of the utilization of Red Koji (Red Mold Rice) in dietary therapy for serum lipid improvement |
Date of disclosure of the study information | 2012/04/09 |
Last modified on | 2017/04/12 09:52:23 |
The randomized controlled clinical trial of the utilization of Red Koji (Red Mold Rice) in dietary therapy for serum lipid improvement
The randomized controlled clinical trial of the utilization of Red Koji (Red Mold Rice) in dietary therapy for serum lipid improvement
The randomized controlled clinical trial of the utilization of Red Koji (Red Mold Rice) in dietary therapy for serum lipid improvement
The randomized controlled clinical trial of the utilization of Red Koji (Red Mold Rice) in dietary therapy for serum lipid improvement
Japan |
Hyperlipemia
Endocrinology and Metabolism |
Others
NO
Examine the usefulness of Red Koji as a dietary supplement in the primary care stage of improvement of life style including dietary therapy in the clinical practice for people with hyperlipidemia
Safety,Efficacy
Confirmatory
Pragmatic
Not applicable
Change of LDL-C from the baseline to 4 and 8 weeks later
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
YES
YES
Institution is not considered as adjustment factor.
NO
Central registration
2
Treatment
Food |
Dietary therapy + Red Koji
Dietary therapy
20 | years-old | <= |
80 | years-old | > |
Male and Female
1)People with LDL-cholesterol level of 140 and over mg/dL without the past of a coronary artery disease
2)patients under an enforcement schedule or enforcement of dietary therapy for hypercholesterolemia
3)Age >=20 years, <80 years (Male and Female)
4)A consent form for participating in this study is submitted
1)Patients with familial hypercholesterolemia or with LDL-cholesterol level of 180 and over mg/dL
2)People with rice allergy, and people who have resistance in eating rice
3)Patients taking statin drugs within 4 weeks (or Probucol within 8 weeks) in the past
4)Patients with type 1 diabetes or diabetic patients with HbA1c level of over 8%
5)Patients with sever diseases other than diabetes, such as liver disease, a renal disease, and cardiac disease
6)Patients with the past, such as a food allergy, idiosyncrasy, and alcoholism
7)People who participated in other clinical trials within the past three months before the start of this clinical trial, or who have participated in other clinical trials at the start of this clinical trial
8)Patients who are pregnant, breastfeeding or intention to becoming pregnant
9)Patients whose LDL-cholesterol level became less than 140 mg/dL by dietary therapy of period I or patients with TG level of 400 and over mg/dL
10)Patients judged unsuitable by the investigator
32
1st name | |
Middle name | |
Last name | Koutaro Yokote |
Graduate School of Medicine, Chiba University
Clinical Cell Biology and Medicine
1-8-1 Inohana, Chuo-ku, 260-8670, Chiba-city
043-226-2092
kyokote@faculty.chiba-u.jp
1st name | |
Middle name | |
Last name | Kazuki Kobayashi |
Graduate School of Medicine, Chiba University
Clinical Cell Biology and Medicine
1-8-1 Inohana, Chuo-ku, 260-8670, Chiba-city
043-226-2092
koba-chi@faculty.chiba-u.jp
Graduate School of Medicine, Chiba University
Biopharm Research Laboratories Inc.
Other
NO
2012 | Year | 04 | Month | 09 | Day |
Unpublished
Completed
2012 | Year | 03 | Month | 19 | Day |
2012 | Year | 05 | Month | 01 | Day |
2016 | Year | 10 | Month | 01 | Day |
2017 | Year | 12 | Month | 31 | Day |
2012 | Year | 04 | Month | 08 | Day |
2017 | Year | 04 | Month | 12 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009074
Research Plan | |
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Research case data specifications | |
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Research case data | |
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