To administer the extract Salacia plant supplementation to Japanese adult male for 4 weeks for analyzing the effectiveness of the immune function and evaluate the effectiveness of an improvement in immune strength through this study.Study design: a double-blind placebo controlled trial.
- Conditions
- Healthy Adult
- Registration Number
- JPRN-UMIN000011732
- Lead Sponsor
- Shiba Palace Clinic
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Male
- Target Recruitment
- 32
Not provided
1) Subjects who have present and/or past history of disease of heart, kidneys, liver and digestive system. 2) Exclusion disorders: atrial fibrillation, arrhythmia, hepatic disease (especially who have present and/or past history of disease of hepatitis), kidney disorder, cerebrovascular disorder, rheumatism, diabetes, dyslipidemia, hypertension, and other chronic diseases. 3) Subjects who contract a disease related to digestive (e.g. obstipation and to have loose bowel). 4) Subjects who have serious anemia. 5) Subjects who regularly take supplementation and medicines included herbal one. 6) Subjects who have allergy to the medicine and food related to this study. 7) Subjects who regularly take food and drug of the effect of calming intestinal disorders within a month. 8) Subjects who drink excessive amounts of alcohol. 9) Smokers. 10) Diabetes. 11) Subjects who are participating in other clinical trials, either participated within 3 months. 12) Subjects who are not considered eligible to participated in this study by medical doctor or the study center.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method immune function
- Secondary Outcome Measures
Name Time Method Intestinal microbiota analysis,Gene expression analysis,safety evaluation