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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Preinitiation |
Unique ID issued by UMIN | UMIN000047688 |
Receipt No. | R000054189 |
Scientific Title | A study to evaluate the safety of long-term intake of plant extract materials |
Date of disclosure of the study information | 2022/05/14 |
Last modified on | 2022/04/18 |
Basic information | ||
Public title | A study to evaluate the safety of long-term intake of plant extract materials | |
Acronym | A study to evaluate the safety of long-term intake of plant extract materials | |
Scientific Title | A study to evaluate the safety of long-term intake of plant extract materials | |
Scientific Title:Acronym | A study to evaluate the safety of long-term intake of plant extract materials | |
Region |
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Condition | |||
Condition | Healthy volunteers | ||
Classification by specialty |
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Classification by malignancy | Others | ||
Genomic information | NO |
Objectives | |
Narrative objectives1 | To investigate the safety of the test food when ingested for 12 consecutive weeks |
Basic objectives2 | Safety |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | Adverse events, Side effects |
Key secondary outcomes |
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 | Prevention | |
Type of intervention |
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Interventions/Control_1 | Intake of test food for 12 weeks | |
Interventions/Control_2 | Intake of placebo for 12 weeks | |
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 |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | 1) Healthy males and females whose age of 20 years or more and less than 65 years
2) Subjects receiving a sufficient briefing of the objective and content of the present study, fully understanding and agreeing to voluntarily participate in the study and being able to personally sign a written informed consent |
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Key exclusion criteria | 1) Subjects with serious cardio-vascular, hepatic, renal, respiratory, endocrine or metabolic disorders or having a medical history of these disorders
2) Subjects who have the possibility of developing allergic symptoms by the test food 3) Female subjects who are pregnant or lactating, or intending to become pregnant during the study 4) Subjects having blood sample of 200 ml or more taken within 1 month, or 400 ml or more within 3 months prior to the start of the present study (e.g. donated blood) 5) Subjects who took part in another study within 3 months prior to the start of the present study or who is currently taking part in another study 6) Subjects deemed unsuitable by the investigator |
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Target sample size | 40 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Kracie Holdings, Ltd. | ||||||
Division name | R&D Innovation Group | ||||||
Zip code | 108-8080 | ||||||
Address | 3-20-20, Kaigan, Minato-ku, Tokyo | ||||||
TEL | 070-3350-0767 | ||||||
s.inamasu@kracie.co.jp |
Public contact | |||||||
Name of contact person |
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Organization | Soiken Inc. | ||||||
Division name | R&D Division | ||||||
Zip code | 560-0082 | ||||||
Address | Senri Life Science Center 13F, 1-4-2, Shinsenri-higashimachi, Toyonaka-shi, Osaka | ||||||
TEL | 06-6871-8888 | ||||||
Homepage URL | |||||||
watanabe_kota@soiken.com |
Sponsor | |
Institute | Soiken Inc. |
Institute | |
Department |
Funding Source | |
Organization | None |
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 | IRB of Fukuda Clinic |
Address | Shin-Osaka brick building 2F, 1-6- 1 Miyahara, Yodogawa-ku, Osaka-shi, Osaka |
Tel | 06-6398-0203 |
fukudaclinicIRB@gmail.com |
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 | 医療法人弘正会ふくだ内科クリニック(大阪府) |
Other administrative information | |||||||
Date of disclosure of the study information |
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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 |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054189 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |