Healthy Japanese subjects
Conditions
Interventions
Duration: Six weeks Test food: Akabudouhanoshizuku Administration: Take four capsules per day after breakfast with water *Daily dose should be taken within the day. If you forget to take the test
Sponsors
ORTHOMEDICO Inc.
Medical Corporation Seishinkai, Takara Clinic Nerima Medical Association, Minami-machi Clinic
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Japanese 2. Women 3. Subjects aged 20 or more and less than 70 4. Healthy subjects 5. Subjects who feel swelling in their legs 6. Subjects who are judged as eligible to participate in the study by the physician 7. Subjects whose swelling volume of the lower leg are large at screening (before consumption; Scr)
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 who currently undergoing treatment for any of the following chronic disease: 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," "Foods with Functional Claims," or other functional food/beverage in daily 5. Subjects who 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, breast-feeding, and planning to become pregnant 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 the study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The swelling volume of the lower leg*1 at six weeks after consumption (6w) *1 The swelling volume of the lower leg = the lower leg volume in the evening - the lower leg volume in the morning | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The swelling volume of the lower leg at two weeks after consumption (2w) 2. The lower leg volume in the morning or evening, subjective symptoms of swollen legs and face (visual analogue scale), and calf circumference (maximum circumference of the lower leg) at 2w and 6w | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed