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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024052
Receipt No. R000027694
Scientific Title Safety evaluation of an excessive consumption of Longvida
Date of disclosure of the study information 2016/10/01
Last modified on 2018/02/14

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Basic information
Public title Safety evaluation of an excessive consumption of Longvida
Acronym Safety evaluation of an excessive consumption of Longvida
Scientific Title Safety evaluation of an excessive consumption of Longvida
Scientific Title:Acronym Safety evaluation of an excessive consumption of Longvida
Region
Japan

Condition
Condition Nothing (healthy subject)
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the safety of excessive consumption of Longvida
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes physical examination
Hematologic test
blood biochemical test
urine analysis
Doctor's questions
adverse events
Key secondary outcomes Questionnaires

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
Food
Interventions/Control_1 Longvida 2000mg/day, 4weeks
Interventions/Control_2 Placebo, 4weeks
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
70 years-old >
Gender Male and Female
Key inclusion criteria 1. Healthy Japanese males and females
2. BMI>=18.5 and <25 kg/m2
3. Subjects who are judged as appropriate for the study by the principal investigator
Key exclusion criteria 1. Subjects who have at least one previous medical history of malignant tumor, heart failure or myocardial infarction
2. Subjects who are patient or have history of cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension or other chronic diseases
3. Subjects who have undergone gastrointestinal tract surgery; except appendectomy
4. Subjects who are currently taking medicines (include herbal medicines) and/or supplements
5. Subjects who are allergic to medicines or the test material of this trial
6. Subjects who are or are possibly pregnant, or are lactating
7. Subjects who participate in other clinical trials in the past 3 months
8. Subjects who work time is irregular
9. Subjects who have been determined ineligible by principal investigator for other reasons
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yutaka Kondo
Organization Omnica Co.,Ltd
Division name Research and development Dept.
Zip code
Address TN Koishikawa BLDG. 5F, 1-15-17 Koishikawa, Bunkyo-ku, Tokyo, JAPAN
TEL 03-5840-9815
Email kondo@omnica.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Satomi Iwata
Organization Omnica Co.,Ltd
Division name Research and development Dept.
Zip code
Address TN Koishikawa BLDG. 5F, 1-15-17 Koishikawa, Bunkyo-ku, Tokyo, JAPAN
TEL 03-5840-9815
Homepage URL
Email iwata@omnica.co.jp

Sponsor
Institute ORTHOMEDICO, Inc.
Institute
Department

Funding Source
Organization Omnica Co.,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
Address
Tel
Email

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)

Other administrative information
Date of disclosure of the study information
2016 Year 10 Month 01 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
2016 Year 09 Month 13 Day
Date of IRB
Anticipated trial start date
2016 Year 09 Month 19 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 09 Month 14 Day
Last modified on
2018 Year 02 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027694

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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