UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050471 |
|---|---|
| Receipt number | R000057485 |
| Scientific Title | A study to evaluate the safety of overdose intake of plant extract materials |
| Date of disclosure of the study information | 2023/03/30 |
| Last modified on | 2023/07/13 23:18:48 |
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Basic information
Public title
Overdose safety test
Acronym
Overdose safety test
Scientific Title
A study to evaluate the safety of overdose intake of plant extract materials
Scientific Title:Acronym
A study to evaluate the safety of overdose intake of plant extract materials
Region
| Japan |
Condition
Condition
healthy person
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the Safety of plant extract materials in Overdose
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Safety evaluation of 1000 mg of plant extract material, which is 5 times the recommended intake.
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: plant extract materials
Dosage and administration: 10 capsules of plant extract materials 50 mg/1 capsule (20 capsules/day, 1000 mg plant extract materials/day) at breakfast 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 who are between 20 and 65 years old (at the time of obtaining consent) and able to go to 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 and are not receiving any related treatment or any kind of drug therapy. Whether or not a person qualifies as an able-bodied person is based on the person's declaration at the start of the examination).
3) The applicant must be able to avoid eating, drinking, and excessive exercise during the examination period, and must be able to lead the same lifestyle (eating and exercise habits, sleep, etc.) as he/she did before the examination period.
4) Those who have been fully informed of the purpose and content of the study, have the capacity to consent, and have voluntarily volunteered to participate in the study based on a good understanding of the purpose and content of the study, and who have agreed to participate in the study in writing.
Key exclusion criteria
1) Patients with a history of treatment for heart failure, myocardial infarction, etc.
2) Exclusion due to disease, etc. (those suffering from or undergoing treatment for atrial fibrillation, arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes, dyslipidemia, hypertension, or other chronic disease, etc.)
3)Those whose physical measurements, physical examination values, and clinical examination values in the preliminary examination show values that are significantly out of the reference range.
4) Those who regularly use pharmaceuticals (including herbal medicines) or supplements
5) Those who have allergies (to pharmaceuticals or food related to the tested products).
6) Pregnant, lactating, or likely to become pregnant during the study period.
7) Who have participated or are currently participating in other clinical trials within one month.
8) Other subjects who are judged by the investigator to be unsuitable for this study.
Target sample size
22
Research contact person
Name of lead principal investigator
| 1st name | Kazuhiko |
| Middle name | |
| Last name | Aida |
Organization
NIPPNCORPORATION
Division name
Innovation Center, Central Research Laboratory
Zip code
2430041
Address
5-1-3 Midorigaoka, Atsugi City, Kanagawa Prefecture
TEL
042-222-6963
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
k-ohno@cli-creative.com
Sponsor or person
Institute
Clinical Creative Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
NIPPNCORPORATION
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
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
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（北海道）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 03 | Month | 30 | 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
Completed
Date of protocol fixation
| 2023 | Year | 02 | Month | 15 | Day |
Date of IRB
| 2023 | Year | 02 | Month | 22 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 30 | Day |
Last follow-up date
| 2023 | Year | 05 | Month | 13 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 03 | Month | 02 | Day |
Last modified on
| 2023 | Year | 07 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057485
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
