Unique ID issued by UMIN | UMIN000027038 |
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Receipt number | R000030997 |
Scientific Title | Safety evaluation of excessive consumption of crocetin.:A randomized, double-blind, placebo-controlled, parallel-group comparison trial. |
Date of disclosure of the study information | 2018/04/18 |
Last modified on | 2018/06/28 16:32:26 |
Safety evaluation of excessive consumption of crocetin.:A randomized, double-blind, placebo-controlled, parallel-group comparison trial.
Safety evaluation of excessive consumption of crocetin.
Safety evaluation of excessive consumption of crocetin.:A randomized, double-blind, placebo-controlled, parallel-group comparison trial.
Safety evaluation of excessive consumption of crocetin.
Japan |
Healthy adults
Not applicable | Adult |
Others
NO
To evaluate the safety of excessive consumption of crocetin.
Safety
Physical examinations
Hematological tests
Blood biochemistry tests
Urinalysis
(0, 2, 4 week)
Questionnaires of subjective symptoms
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
2
Treatment
Food |
Duration: 4 weeks
Test material: Soft capsule containing 7.5 mg of crocetin.
Five capsules per day
Duration: 4 weeks
Test material: Placebo soft capsule
Five capsules per day
20 | years-old | <= |
Not applicable |
Male and Female
Healthy adults of Japanese
a) At least one previous medical history of malignant tumor, heart failure or myocardial infarction
b) Currently under the treatment for either cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension or other chronic diseases
c) Those who use or take "Foods for Specified Health Uses" and "Foods with Functional Claims" in daily
d) Currently taking medicines and/or herbal medicines
e) Those who are allergic to medicines or foods related to the test material of this trial.
f) Pregnant women, lactating women, or women who plan to become a pregnant during the trial period.
g) Enrolled into other clinical trials within the last 3 months before agreeing to participate in this trial
h) Others considered as inappropriate for the study by the physician
30
1st name | |
Middle name | |
Last name | Kazuo YAMAMOTO |
ORTHOMEDICO, Inc.
R&D Department
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1 Koishikawa, Bunkyo-ku, Tokyo.
03-3818-0610
kazu@orthomedico.jp
1st name | |
Middle name | |
Last name | Naoko SUZUKI |
ORTHOMEDICO, Inc.
R&D Department
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1 Koishikawa, Bunkyo-ku, Tokyo.
03-3818-0610
nao@orthomedico.jp
ORTHOMEDICO, Inc.
RIKEN VITAMIN CO., LTD.
Profit organization
Seishin-kai Medical Association Inc, Takara Medial Clinic.
NO
医療法人社団 盛心会 タカラクリニック
2018 | Year | 04 | Month | 18 | Day |
Published
Yamashita S, Umigai N, Kakinuma T, Takara T. Safety evaluation of excessive intake of crocetin in healthy adult volunteers:A randomized, double-blind, placebo-controlled, parallel-group comparison trial. Jpn Pharmacol Ther. 2018, 46:393-401
Completed
2017 | Year | 04 | Month | 17 | Day |
2017 | Year | 04 | Month | 19 | Day |
2017 | Year | 07 | Month | 01 | Day |
2017 | Year | 08 | Month | 08 | Day |
2017 | Year | 04 | Month | 18 | Day |
2018 | Year | 06 | Month | 28 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030997
Research Plan | |
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Research case data | |
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