A randomized, double-blind, placebo-controlled, parallel-group study to evaluate the safety and efficacy of a dietary supplement containing wine processing residue powder in healthy adult wome
- Conditions
- Healthy AdultsAntioxidant effect, anti-inflammatory effect, blood flow promotion, etc.Healthy Adults
- Registration Number
- JPRN-jRCT1031230157
- Lead Sponsor
- Hida Noriko
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 45
Persons who meet all of the following criteria shall be eligible.
1) Persons who are between 40 and 60 years of age at the time consent is obtained.
2) Female
3) Persons who are capable of consenting, abide by the rules of compliance during participation in the research, undergo the preliminary examination specified in the research protocol, and are able to report subjective symptoms, etc.
4) Persons who have been judged by the physician in charge of the research to be eligible to participate in this study based on the preliminary examination specified in the research protocol.
Persons who have any of the following will not be included in this study
1) Persons with a history of drug abuse or dependence, alcohol abuse or dependence, or heart, liver, renal, pulmonary, ocular, or hematologic disease that may affect the safety or the evaluation of this study.
2) Patients who are taking drugs (including dietary supplements and dietary supplements) that may affect the evaluation and safety of this study.
3) Have a history of drug allergy
4) Persons who regularly use excessive amounts of alcohol (those who cannot maintain abstinence from alcohol during the study period)
5) Those who are within 3 months of participating in another clinical research study
6) Other subjects who are judged by the investigator to be ineligible for this study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage change in whitening (spots) index at the end of the treatment periodPercentage change in self-assessment and amount of change in the pre- and post-treatment questionnaires
- Secondary Outcome Measures
Name Time Method Evaluate the rate and amount of change in skin beauty, mental stress, joint pain, and pre- and post-dose questionnaires at the end of the treatment period.