Healthy male/female adults
Conditions
Interventions
Use of the test additive (4 tablets) once a day, while taking a bath.
Not using the test additive, while taking a bath.
Sponsors
CPCC Company Limited
HOTTAB. Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Male/female subjects ranging in age from 30 to 59 at informed consent. (2) Subjects fully realized that the subjects themselves must be in a stressful condition. (3) Subjects who are dissatisfied with their sleep condition. (4) Women who reached the menopause, or ranging in menstruation from 28 to 32 days steadily. (5) Subjects who can take a bath once a day, during this trial. (6) Subjects who can give informed consent to take part in this trial, after being provided with an explanation of our experimental protocol detail.
Exclusion criteria
Exclusion criteria: (1) Subjects who take steadily in the health-specific/functional/supplementary/health foods which might affect this trial, and will have any difficulty in giving up taking them after the consent. (2) Subjects who have taken affecting medicines, and have any difficulty in refraining from taking them during this trial. (3) Subjects having an irregular life rhythm with irregular shift work or midnight one. (4) Subjects with previous and/or current medical history of serious diseases in heart, liver, kidney and/or digestive organs. (5) Pregnant, possibly pregnant, and lactating women. (6) Subjects having the possibility of unconsciousness induced by arrhythmia, hypertension, orthostatic hypotension, sleep-apnea syndrome, or epileptic/hypoglycemic fit. (7) Subjects with some kind of skin symptom, just like an itch and a rash, by using a bath additive. (8) Subjects who are under other clinical trials with some kind of medicine/food, or participated in those within the last four weeks before this trial, or are planning to join those after the consent. (9) Subjects who donated their blood components and/or whole blood (200 mL) within a month to this trial. (10) Males who donated their whole blood (400 mL) within the last three months to this trial. (11) Females who donated their whole blood (400 mL) within the last four months to this trial. (12) Males who will be collected in total of their blood (1200 mL) within the last twelve months, after adding the blood amounts planning to be sampled in this trial. (13) Females who will be collected in total of their blood (800 mL) within the last twelve months, after adding the blood amounts planning to be sampled in this trial. (14) Others who have been determined as ineligible for participation, judging from the principal/sub investigator's opinions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Simplified questionnaire survey about mental stress (simple ver.: 23 questions) 2. Sleeping parameter by activity tracker 3. Pittsburg sleep questionnaire | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Test for immunological capacity 2. Neutrophilic phagocytosis 3. NK-cell activity 4. The Profile of Mood States Second Edition (Japanese short ver.) | — |
Countries
Japan
Contacts
Public ContactMasanori Numa
CPCC Company Limited Clinical Planning Department
Outcome results
None listed