A study for effects on body surface temperature and feeling of "Ninnikushoga" intake under cool conditions in healthy adult female who are concerned about cold.
- Conditions
- Healthy adult
- Registration Number
- JPRN-UMIN000044513
- Lead Sponsor
- EP Mediate Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 16
Not provided
(1)Subjects who have been diagnosed underlying disease accompanied with angiopathy (e.g. arteriosclerosis obliterans, arteritis obliterans, collagen disease and diabetes, etc.) (2)Subjects who constantly take medicines affecting the skin surface temperature(e.g. warfarin) (3)Subjects who eat food for specified health or health food affecting the skin surface temperature(e.g. healthy food including garlic or ginger) at least once a week (4)Subjects having food allergy (5)Subjects who are smokers or have smoked within the past 3 months (6)Subjects who have a scar affecting the skin surface temperature and autonomic function on fingers, palms, toes and insteps (7)Subjects who have worked shifts day and night or are planned to work shifts day and night from a month before obtaining the consent for this study to the date of the completion this study (8)Subjects who have gone abroad or are planned to go abroad from a month before obtaining the consent for this study to the date of the completion this study (9)Subjects who have participated in other clinical study within the last one month prior to the current study or are planned to participate in other clinical study after informed consent for the current study (10)Subjects who intend to become pregnant or lactating during the study (11)Subjects having a disease requiring treatment or taking medicines (12)Subjects having a history of serious diseases (13)Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire (14)Subjects who are not judged as healthy based on the results of clinical and physical examination on preliminary examination (15)Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Area under the curve of body surface temperature
- Secondary Outcome Measures
Name Time Method Body surface temperature Autonomic function Subjective symptoms questionnaire