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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000027038
Receipt No. 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

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Basic information
Public title Safety evaluation of excessive consumption of crocetin.:A randomized, double-blind, placebo-controlled, parallel-group comparison trial.
Acronym Safety evaluation of excessive consumption of crocetin.
Scientific Title Safety evaluation of excessive consumption of crocetin.:A randomized, double-blind, placebo-controlled, parallel-group comparison trial.
Scientific Title:Acronym Safety evaluation of excessive consumption of crocetin.
Region
Japan

Condition
Condition Healthy adults
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the safety of excessive consumption of crocetin.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Physical examinations
Hematological tests
Blood biochemistry tests
Urinalysis
(0, 2, 4 week)
Key secondary outcomes Questionnaires of subjective symptoms

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 Duration: 4 weeks
Test material: Soft capsule containing 7.5 mg of crocetin.
Five capsules per day
Interventions/Control_2 Duration: 4 weeks
Test material: Placebo soft capsule
Five capsules per day
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 Healthy adults of Japanese
Key exclusion criteria 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
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuo YAMAMOTO
Organization ORTHOMEDICO, Inc.
Division name R&D Department
Zip code
Address 2F Sumitomo Fudosan Korakuen Bldg., 1-4-1 Koishikawa, Bunkyo-ku, Tokyo.
TEL 03-3818-0610
Email kazu@orthomedico.jp

Public contact
Name of contact person
1st name
Middle name
Last name Naoko SUZUKI
Organization ORTHOMEDICO, Inc.
Division name R&D Department
Zip code
Address 2F Sumitomo Fudosan Korakuen Bldg., 1-4-1 Koishikawa, Bunkyo-ku, Tokyo.
TEL 03-3818-0610
Homepage URL
Email nao@orthomedico.jp

Sponsor
Institute ORTHOMEDICO, Inc.
Institute
Department

Funding Source
Organization RIKEN VITAMIN CO., LTD.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Seishin-kai Medical Association Inc, Takara Medial Clinic.
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 医療法人社団 盛心会 タカラクリニック

Other administrative information
Date of disclosure of the study information
2018 Year 04 Month 18 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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
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 Completed
Date of protocol fixation
2017 Year 04 Month 17 Day
Date of IRB
Anticipated trial start date
2017 Year 04 Month 19 Day
Last follow-up date
2017 Year 07 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2017 Year 08 Month 08 Day

Other
Other related information

Management information
Registered date
2017 Year 04 Month 18 Day
Last modified on
2018 Year 06 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030997

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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