Healthy Japanese subjects
Conditions
Interventions
Duration: Four weeks Test food: Ginger capsule Administration: Take one capsule in the morning *If you forget to take the test food, take it as soon as you remember. Daily dose should be taken wi
Sponsors
ORTHOMEDICO
Medical Corporation Seishinkai, Takara Clinic Nerima Medical Association, Minami-machi Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Japanese 2. Men or women 3. Adults 4. Healthy subjects 5. Subjects who do not have abdominal pain or whose abdominal pain subsides for less than one day per week within three months before briefing 6. Subjects who have loose stools at least three days per week and repeat for the last two months 7. Subjects whose defecation frequency a week prior to Scr is between 10 to 20 8. Subjects whose stool shape of all defecation a week prior to Sc are "4," "5," or "6"* *4: "Like a sausage and smooth surface" 5: "Soft blobs with clear cut edges" 6: "A mushy stool with ragged edges"
Exclusion criteria
Exclusion criteria: 1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction 2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Subjects currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. Subjects who use or take "Foods for Specified Health Uses," or "Foods with Functional Claims" in daily 5. Subjects who are currently taking medications (including herbal medicines) and supplements 6. Subjects who are allergic to medicines and/or the test food related products 7. Subjects who are pregnant, lactating, or planning to become pregnant during this trial 8. Subjects who suffer from COVID-19 9. Subjects who have been enrolled in other clinical trials within the last 28 days before the agreement to participate in this trial or plan to participate another trial during this trial 10. Subjects who are judged as ineligible to participate in this study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The defecation frequency in period 6* *Period 6: The 4th week after consumption of the test food | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The defecation frequency in period 3, 4, and 5 2. The numbers of defecation days and amount of defecation in period 3, 4, 5, and 6* 3. The rate of each state for stool shape, stool smell, and exhilarating feeling of defecation in period 3, 4, 5, and 6* 4. Frequency of defecation desire, feeling of defecation desire, and feeling of defecation urgency measured by visual analogue scale (VAS) at four weeks after consumption (4w) 5. Water content in stool, each score of the Gastrointestinal Symptom Rating Scale (GSRS) (total score, Reflux, Abdominal pain, Indigestion, Diarrhoea, and Constipation), and each score of the MOS Short-Form 36-Item Health. Survey (SF-36) {Physical Component Summary (PCS), Mental Component Summary (MCS), Role-social Component Summary (RCS), Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional, Mental Health} at 4w *Period 1: Seven days prior to screening (before consumption: Scr) Period 2: Seven days prior to the initial day to consume the test food Period 3: The 1st week after consumption of the test food Period 4: The 2nd week after consumption of the test food Period 5: The 3rd week after consumption of the test food Period 6: The 4th week after consumption of the test food | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed