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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Preinitiation |
Unique ID issued by UMIN | UMIN000042764 |
Receipt No. | R000048801 |
Scientific Title | Effect of feeding black ginger supplement on improvement of cold intolerance |
Date of disclosure of the study information | 2021/01/13 |
Last modified on | 2020/12/16 |
Basic information | ||
Public title | Effect of feeding black ginger supplement on improvement of cold intolerance | |
Acronym | Improvement of cold intolerance by feeding black ginger supplement | |
Scientific Title | Effect of feeding black ginger supplement on improvement of cold intolerance | |
Scientific Title:Acronym | Effect of feeding black ginger supplement on improvement of cold intolerance | |
Region |
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Condition | ||
Condition | Healthy adult | |
Classification by specialty |
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Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | Investigate the effects of feeding black ginger supplement on improvement of cold tolerance |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | Skin surface temperature of fingers and feet |
Key secondary outcomes | Vas questionaire
(1)cold intolerance of whole body (2)cold intolerance of limbs (3)fatigue (4)shoulder stiffness (5)quality of sleep (6)constipation |
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 | The subjects ingested the placebo meal for 28 days. | |
Interventions/Control_2 | The subjects ingested the active meal for 28 days. | |
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 male and female between 20 and 70 years old
2) Individuals who has subjective symptoms of cold intolerance 3) Individuals who can refrain from over drinking and over eating during the test period 4) Individuals who understand the purpose and contents of the experiment |
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Key exclusion criteria | 1)Subjects who are contracting or treating severe diabetes and kidney and/or liver diseases
2)Individuals who have a chronic diseases and regularly use drugs 3)Pregnant women, or women with intending to become pregnant, and lactating woman 4)Individuals participating or intending to participate in a drug administration test 5)Individuals judged by the doctor to be unsuitable |
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Target sample size | 60 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Univercity of Nagasaki | ||||||
Division name | Regional Partnership Center | ||||||
Zip code | 8512195 | ||||||
Address | 1-1-1 Manabino, Nagayo-cho, Nishisonogi-gun, Nagasaki, Japan, 851-2195 | ||||||
TEL | 0958135216 | ||||||
katanaka@sun.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | Univercity of Nagasaki | ||||||
Division name | Regional Partner Center | ||||||
Zip code | 8512195 | ||||||
Address | 1-1-1 Manabino, Nagayo-cho, Nishisonogi-gun, Nagasaki, Japan, 851-2195 | ||||||
TEL | 0958135216 | ||||||
Homepage URL | |||||||
katanaka@sun.ac.jp |
Sponsor | |
Institute | Univercity of Nagasaki |
Institute | |
Department |
Funding Source | |
Organization | Charle 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 | Univercity of Nagasaki |
Address | 1-1-1 Manabino, Nagayo-cho, Nishisonogi-gun, Nagasaki, Japan, 851-2195 |
Tel | 0958135216 |
katanaka@sun.ac.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 | 60 |
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://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048801 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |