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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | No longer recruiting |
Unique ID issued by UMIN | UMIN000042595 |
Receipt No. | R000048616 |
Scientific Title | A verification study of safety evaluation of excessive consumption of the test food: a randomized, placebo-controlled, double-blind, parallel-group comparison study |
Date of disclosure of the study information | 2020/11/30 |
Last modified on | 2021/01/18 |
Basic information | ||
Public title | A verification study of safety evaluation of excessive consumption of the test food | |
Acronym | A verification study of safety evaluation of excessive consumption of the test food | |
Scientific Title | A verification study of safety evaluation of excessive consumption of the test food: a randomized, placebo-controlled, double-blind, parallel-group comparison study | |
Scientific Title:Acronym | A verification study of safety evaluation of excessive consumption of the test food | |
Region |
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Condition | |||
Condition | Healthy Japanese subjects | ||
Classification by specialty |
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Classification by malignancy | Others | ||
Genomic information | NO |
Objectives | |
Narrative objectives1 | To verify the safety of excessive consumption of the test food for four weeks in healthy Japanese adult subjects |
Basic objectives2 | Safety |
Basic objectives -Others | |
Trial characteristics_1 | Confirmatory |
Trial characteristics_2 | Pragmatic |
Developmental phase | Not applicable |
Assessment | |
Primary outcomes | 1. Incidence of side effects
2. Incidence of adverse events |
Key secondary outcomes | 1. The proportion of subjects whose values of blood test and urinalysis are outside the reference range after intervention despite within the reference range at screening (before intervention)
2. Physical measurement 3. Urinalysis 4. Blood test |
Base | |
Study type | Interventional |
Study design | |
Basic design | Parallel |
Randomization | Randomized |
Randomization unit | Individual |
Blinding | Double blind -all involved are blinded |
Control | Placebo |
Stratification | YES |
Dynamic allocation | NO |
Institution consideration | Institution is not considered as adjustment factor. |
Blocking | NO |
Concealment |
Intervention | ||
No. of arms | 2 | |
Purpose of intervention | Prevention | |
Type of intervention |
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Interventions/Control_1 | Duration: Four weeks
Test food: Tablet containing garlic extract Administration: Take a total of 15 tablets per day with water. *If you forget to take the test food, take it as soon as you remember within the day. |
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Interventions/Control_2 | Duration: Four weeks
Test food: Placebo Administration: Take a total of 15 tablets per day with water. *If you forget to take the test food, take it as soon as you remember within the day. |
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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. Japanese
2. Male or female 3. Subjects aged 20 or more 4. Healthy subjects 5. Subjects who are judged as eligible to participate in the study by the physician |
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Key exclusion criteria | 1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction
2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Subjects who currently undergoing treatment for any of the following chronic disease: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. Subjects who take "Foods for Specified Health Uses," "Foods with Functional Claims," or other functional food/beverage in daily use 5. Subjects who currently taking medications (including herbal medicines) and supplements 6. Subjects who are allergic to medicines and/or the test food related products 7. Subjects who are pregnant, lactation, or planning to become pregnant 8. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial or plan to participate another trial during this trial 9. Subjects who are judged as ineligible to participate in the study by the physician |
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Target sample size | 20 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Medical Corporation Seishinkai, Takara Clinic | ||||||
Division name | Director | ||||||
Zip code | 141-0022 | ||||||
Address | 9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan | ||||||
TEL | 03-5793-3623 | ||||||
t-takara@takara-clinic.com |
Public contact | |||||||
Name of contact person |
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Organization | ORTHOMEDICO Inc. | ||||||
Division name | R&D Department | ||||||
Zip code | 112-0002 | ||||||
Address | 2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan. | ||||||
TEL | 03-3818-0610 | ||||||
Homepage URL | |||||||
nao@orthomedico.jp |
Sponsor | |
Institute | ORTHOMEDICO Inc. |
Institute | |
Department |
Funding Source | |
Organization | Daicel Corporation |
Organization | |
Division | |
Category of Funding Organization | Profit organization |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | Medical Corporation Seishinkai, Takara Clinic
Nerima Medical Association, Minami-machi Clinic |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | the ethical committee of the Takara Clinic, Medical Corporation Seishinkai |
Address | 9F Taisei Building, 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan. |
Tel | 03-5793-3623 |
IRB@takara-clinic.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 | 医療法人社団盛心会 タカラクリニック (東京都)
Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan) 南町医院 (東京都) Nerima Medical Association, Minami-machi Clinic (Tokyo, Japan) |
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 | 22 |
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 |
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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://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048616 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |