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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000033891 |
Receipt No. | R000038653 |
Scientific Title | Evaluation of physical function in elderly subjects by botanical extract-formulated food: a randomized, double-blind, placebo-controlled study |
Date of disclosure of the study information | 2018/09/03 |
Last modified on | 2019/07/09 |
Basic information | ||
Public title | Evaluation of physical function in elderly subjects by botanical extract-formulated food: a randomized, double-blind, placebo-controlled study | |
Acronym | Evaluation of physical function in elderly subjects by botanical extract -formulated food | |
Scientific Title | Evaluation of physical function in elderly subjects by botanical extract-formulated food: a randomized, double-blind, placebo-controlled study | |
Scientific Title:Acronym | Evaluation of physical function in elderly subjects by botanical extract -formulated food | |
Region |
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Condition | ||
Condition | Not applicable | |
Classification by specialty |
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Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | To evaluate the effect of intake of botanical extract-formulated food for 8 weeks on physical function in elderly subjects aged 65-74. |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase | Not applicable |
Assessment | |
Primary outcomes | 6-Minute Walk Test |
Key secondary outcomes | Timed Up and Go Test
Chair stand Test Handgrip strength Test Sit and Reach Test Profile of Mood States 2nd Edition Borg scale VAS (Visual analogue scale) Clinical examination |
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 | Treatment | |
Type of intervention |
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Interventions/Control_1 | Intake of test food for 8 weeks | |
Interventions/Control_2 | Intake of placebo food for 8 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. Males and females aged 65-74 years
2. Subjects who can carry out"Timed Up and Go Test" 3. Subjects who can carry out"6-Minute Walk Test" 4. Subjects who can visit the medical institution at the scheduled visit date 5. Subjects who recognize the object and contents of the study and submit the written informed consent |
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Key exclusion criteria | 1. Subjects with heart disease
2. Subjects with serious diseases (diabetes,hypertension, hyperlipidemia, liver disease, or kidney damage) 3. Subjects with respiratory diseases 4. Subjects who have experienced dizziness, syncope, and transient sight loss 5. Subjects with musculoskeletal disorders limiting physical activities 6. Subjects who take medicine affecting heart rate 7. Subjects who have allergy related to the test foods 8. Subjects who had a habit to ingest medicine, foods for specified health uses, and foods with function claims 9. Subjects who are difficult to swallow 10. Subjects who are ineligible due to physician's judgment |
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Target sample size | 34 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Miyawaki Orthopedic Clinic | ||||||
Division name | Hospital director | ||||||
Zip code | 061-1431 | ||||||
Address | 3-1-6 Ariake, Eniwa, Hokkaido, Japan | ||||||
TEL | 0123-33-4026 | ||||||
Miyawaki1571@north-wind.ne.jp |
Public contact | |||||||
Name of contact person |
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Organization | New drug research center, Inc. | ||||||
Division name | Clinical Research Dept. | ||||||
Zip code | 061-1445 | ||||||
Address | 452-1Toiso,Eniwa-shi,Hokkaido, Japan | ||||||
TEL | 0123-34-0412 | ||||||
Homepage URL | |||||||
s-tomita@ndrcenter.co.jp |
Sponsor | |
Institute | Maruzen Pharmaceuticals Co., Ltd. |
Institute | |
Department |
Funding Source | |
Organization | Maruzen Pharmaceuticals 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 | Miyawaki Orthopedic Clinic Clinical Trial Review Committee |
Address | 3-1-6 Ariakecho, Eniwa City, Hokkaido |
Tel | 0123-33-4026 |
d-kameda@mediffom.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 |
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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 | 34 |
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 |
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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=R000038653 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |