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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000045742
Receipt No. R000052122
Scientific Title Open-label safety evaluation of functional food materials including cannabidiol in healthy volunteers.
Date of disclosure of the study information 2021/10/13
Last modified on 2021/10/22

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Basic information
Public title Open-label safety evaluation of functional food materials including cannabidiol in healthy volunteers.
Acronym Safety evaluation of cannabidiol.
Scientific Title Open-label safety evaluation of functional food materials including cannabidiol in healthy volunteers.
Scientific Title:Acronym Safety evaluation of cannabidiol.
Region
Japan

Condition
Condition Not applicable
Classification by specialty
Not applicable
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Open-label safety evaluation of functional food materials including cannabidiol in healthy volunteers.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Subjective symptoms
Blood pressure, Pulse rate
Clinical laboratory test
Key secondary outcomes POMS 2
STAI
PMA-Impact (only in premenopausal women)
Self-rating Depression Scale
Pittsburgh Sleep Quality Index

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
69 years-old >=
Gender Male and Female
Key inclusion criteria 1.Male or female Japanese subjects between 20 and 69 years old at the date of signing informed consent.
2.Healthy subjects with no therapy.
3.Subjects who can visit on schedule, and record their life diary every day.
4.Subjects who were fully informed of the objectives and contents, had a consent ability and voluntarily agreed to participate to the study in written consent.
Key exclusion criteria 1.Subjects who have diabetes mellitus, liver disease, kidney disease, cardiovascular disease, or medical history.
2.Subjects who were judged as to be inappropriate by the data of laboratory test at the screening period.
3.Subjects who have any allergies.
4.Subjects who smoke more than 1 pack on average.
5.Subjects who regularly use pharmaceuticals, quasi-drugs, foods for specified health use foods with functional claims, supplements, health food, etc.
6.Subjects who drink more than 1,000mL of beer(5%) per day (40g of alcohol).
7.Subjects who are pregnant, breastfeeding, or plan to become pregnant or breastfeeding during the study period.
8.Subjects who participated or are planning to participate in other clinical trials within one month from the time of obtaining consent, or who are planning to participate
9.Subjects who are judged by the investigator to be inappropriate for participate in this study.
Target sample size 10

Research contact person
Name of lead principal investigator
1st name Kazumoto
Middle name
Last name Sasaki
Organization Sasaki Memorial Hospital, Ichigenkai Medical Corporation
Division name Director
Zip code 359-1144
Address 1-7-25 Nishitokorozawa, Tokorozawa-shi, Saitama-ken Japan
TEL 04-2923-7751
Email soumuka@sasaki-memorial.com

Public contact
Name of contact person
1st name Hiroki
Middle name
Last name Yoshimura
Organization APO PLUS STATION CO., LTD
Division name CRO Business division
Zip code 103-0027
Address 2-14-1 Nihonbashi, Chuo-ku, Tokyo
TEL 03-6386-8801
Homepage URL
Email h-yoshimura@apoplus.co.jp

Sponsor
Institute ONE-INCH LTD.
Institute
Department

Funding Source
Organization ONE-INCH LTD.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Nihonbashi Sakura Clinic
Address 1-9-2 Nihonbashikayabacho, Chuo-ku, Tokyo
Tel 03-6661-9061
Email c-irb_ug@neues.co.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

Other administrative information
Date of disclosure of the study information
2021 Year 10 Month 13 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 No longer recruiting
Date of protocol fixation
2021 Year 09 Month 22 Day
Date of IRB
2021 Year 09 Month 22 Day
Anticipated trial start date
2021 Year 10 Month 16 Day
Last follow-up date
2021 Year 11 Month 27 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information none

Management information
Registered date
2021 Year 10 Month 13 Day
Last modified on
2021 Year 10 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052122

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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