Unique ID issued by UMIN | UMIN000022822 |
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Receipt number | R000026307 |
Scientific Title | Effect of coadministration of ume paste (Prunus mume) and ginger powder on intolerance to cold |
Date of disclosure of the study information | 2016/06/22 |
Last modified on | 2018/06/26 10:15:40 |
Effect of coadministration of ume paste (Prunus mume) and ginger powder on intolerance to cold
Effect of coadministration of ume paste (Prunus mume) and ginger powder on intolerance to cold
Effect of coadministration of ume paste (Prunus mume) and ginger powder on intolerance to cold
Effect of coadministration of ume paste (Prunus mume) and ginger powder on intolerance to cold
Japan |
Healthy volunteers
Adult |
Others
NO
To evaluate the effect of coadministration of ume paste and ginger powder on intolerance to cold in female subjects who suffer from that symptom.
Efficacy
Exploratory
Explanatory
Not applicable
Change from baseline of mean body surface temperature of the following parts measured by infrared thermography (Time frame: Every 4 weeks between 0 and 20 weeks)
- Fingertip (the first joints of 5 fingers)
- Toe
1) Change from baseline of maximum and minimum body surface temperature of the following parts measured by infrared thermography (Time frame: Every 4 weeks between 0 and 20 weeks)
- Fingertip (the first joints of 5 fingers)
- Toe
2) Change from baseline of mean, maximum, and minimum body surface temperature of the following parts measured by infrared thermography (Time frame: Every 4 weeks between 0 and 20 weeks)
- Forearm
- Hand
- Lower thigh
- Foot
3) Change of subjective symptoms of intolerance to cold by a modified VAS (Time frame: 0, 8, 12, and 20 weeks)
4) Change of basal body temperature (Time frame: Everyday throughout the trial)
5) Recovery of body surface temperature after cold water loading test (Subjects immerse their hands in 10 degrees C water for 1 min, and then the body surface temperature of fingers and backs of their hands are measured at 0, 5, and 10 min later by infrared thermography.)(Time frame: Every 4 weeks between 0 and 20 weeks)
Interventional
Cross-over
Randomized
Individual
Double blind -all involved are blinded
Placebo
NO
NO
NO
Central registration
2
Prevention
Food |
Subjects receive 4 capsules (1200 mg)/day containing ume paste and ginger powder for 8 weeks.
Subjects receive 4 placebo capsules (1200 mg)/day for 8 weeks.
20 | years-old | <= |
70 | years-old | >= |
Female
Healthy with subjective complaint of intolerance to cold
1) Taking medicines or functional food that may affect the trial
2) Participation in any clinical trial within 90 days of the commencement of the trial
3) In pregnancy or nursing a child
4) History of severe disease and/or major surgery
5) Judged as ineligible by clinical investigators
30
1st name | |
Middle name | |
Last name | Fumiko Higashikawa |
Hiroshima University, Institute of Biomedical & Health Sciences
Project Research Center for Clinical Trial and Preventive Medicine
Kasumi 1-2-3, Minami-ku, Hiroshima 734-8551, JAPAN
082-257-1533
fumiko@hiroshima-u.ac.jp
1st name | |
Middle name | |
Last name | Fumiko Higashikawa |
Hiroshima University, Institute of Biomedical & Health Sciences
Project Research Center for Clinical Trial and Preventive Medicine
Kasumi 1-2-3, Minami-ku, Hiroshima 734-8551, JAPAN
082-257-1533
fumiko@hiroshima-u.ac.jp
Hiroshima University
KAWAMOTO FOODS CO., LTD.
Profit organization
NO
広島大学病院(広島県)
2016 | Year | 06 | Month | 22 | Day |
Unpublished
Completed
2016 | Year | 06 | Month | 21 | Day |
2016 | Year | 10 | Month | 01 | Day |
2016 | Year | 06 | Month | 21 | Day |
2018 | Year | 06 | Month | 26 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026307
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