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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000046475
Receipt No. R000053025
Scientific Title Overdose safety study using rosemary material
Date of disclosure of the study information 2022/01/06
Last modified on 2021/12/25

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Basic information
Public title Overdose safety test
Acronym Overdose safety test
Scientific Title Overdose safety study using rosemary material
Scientific Title:Acronym Overdose safety study using rosemary material
Region
Japan

Condition
Condition healthy person
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluating the safety of rosemary materials in overdose
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Safety assessment of the recommended intake of 1000 mg rosemary material, which is five times the recommended intake of 200 mg rosemary material
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Duration:4 weeks
Test food:Rosemary material
Dosage and Administration:Take 5 rosemary capsules twice a day, after breakfast, lunch and dinner.
Interventions/Control_2
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
65 years-old >=
Gender Male and Female
Key inclusion criteria 1.Age:Men and women between 20 and 65 years old (at the time of obtaining consent) who are able to visit the hospital.
2.Healthy subjects (Healthy subjects in this study are defined as those who do not have any serious organ disorder or specific disease, who are not receiving any related treatment, and who are not receiving any medication. Whether or not a person falls under the category of healthy person shall be based on the declaration of the person himself/herself at the start of the study.)
3.Must be able to consume the test food for 4 weeks
4.Those who do not plan to change their daily habits during the examination period.
5.Persons for whom written consent can be obtained
6.Those who do not meet the following exclusion criteria for study participants
Key exclusion criteria 1.Those with a history of treatment for heart failure, myocardial infarction, etc.
2.Exclusion due to disease, etc. (those undergoing treatment for atrial fibrillation, arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes, dyslipidemia, hypertension, other chronic diseases, etc.)
3.Those who meet the Japanese Society for Medical Checkup criteria D (medical care required). However, this does not apply to those who are judged by the physician to be within the normal error range.
4.Those who regularly use medicines (including herbal medicines)and supplements
5.Those with allergies (to pharmaceuticals and test product-related foods)
6.Pregnant, lactating, or likely to become pregnant during the study period
7.Those who have participated or are currently participating in other clinical trials within one month
8.Any other person who is judged by the principal investigator to be inappropriate for this study.
Target sample size 22

Research contact person
Name of lead principal investigator
1st name Kazuhiko
Middle name
Last name Aida
Organization NIPPN CORPORATION
Division name Innovation Center, Central Research Laboratory
Zip code 243-0041
Address 5-1-3 Midorigaoka, Atsugi City, Kanagawa Prefecture
TEL 042-222-6963
Email kaida@nippn.co.jp

Public contact
Name of contact person
1st name KAZUHIRO
Middle name
Last name OHNO
Organization Clinical Creative Co., Ltd.
Division name Pharmaceutical Development Division
Zip code 0620933
Address 1-12-102, Hiragishi 3-13-1-12, Toyohira-ku, Sapporo City, Hokkaido
TEL 09031166218
Homepage URL
Email k-ohno@cli-creative.com

Sponsor
Institute Clinical Creative Co., Ltd.
Institute
Department

Funding Source
Organization NIPPN CORPORATION
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Sapporo Yurinokai Hospital Clinical Trial Review Committee
Address 11-186 Yurigahara, Kita-ku, Sapporo-shi, Hokkaido
Tel 011-771-1501
Email info@yurinokai.jp

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 札幌百合の会病院
Medical Corporation Association Sapporo Yurinokai Hospital

Other administrative information
Date of disclosure of the study information
2022 Year 01 Month 06 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 Preinitiation
Date of protocol fixation
2021 Year 11 Month 10 Day
Date of IRB
2021 Year 11 Month 24 Day
Anticipated trial start date
2022 Year 01 Month 06 Day
Last follow-up date
2022 Year 02 Month 19 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2021 Year 12 Month 25 Day
Last modified on
2021 Year 12 Month 25 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053025

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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