A verification study for improving unidentified complaints with the test food containing Korean ginseng in healthy subjects: a randomized, single-blind, placebo-controlled, parallel-group trial
- Conditions
- Healthy Japanese subjects
- Registration Number
- JPRN-UMIN000033112
- Lead Sponsor
- ORTHOMEDICO Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 48
Not provided
1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, myocardial infarction, endometriosis, uterine myoma, and mental disorders 2. Currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver failure, kidney failure, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 3. Subjects who are undergoing medical treatment for erectile dysfunction (ED), prostatic hyperplasia, or a thyroid disorder 4. Subjects who have been diagnosed with a menopausal disorder and no treatment 5. Subjects who are on medication for any other diseases 6. Subjects who have suppurative inflammation (except for small cuts and scratches) 7. Subjects who use or take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage in daily 8. Subjects who currently take sleeping pills or sleep-inducing drugs 9. Subjects who currently take painkillers such as loxoprofen (Loxonin) and others 10. Subjects who currently take other medications (including herbal medicines) and supplements 11. Subjects who are allergic to medicines and/or the test food related products 12. Subjects who are pregnant, breast-feeding, or planning to become pregnant 13. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial 14. Subjects who are judged as ineligible to participate in the study by the physician
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method A questionnaire about unidentified complaints * Each item is assessed with a seven-point grading scale and the smaller number indicates more severe subjective symptoms. Furthermore, compared the results of the questionnaire at screening (before consumption) and at 4, 8, and 12 weeks after consumption, the grading scale is increased by 3 points and more indicating complete response, by 2 points indicating improvement, by 1 points indicating slight improvement, and by 0 points indicating maintaining health while the grading scale is decreased by 1 point and more indicating worsening.
- Secondary Outcome Measures
Name Time Method