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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.

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. - Effectiveness of an Improvement in Immune Strength by Taking the Extract Salacia Plant Supplementation for Evaluation.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000011732
Enrollment
30
Registered
2013-09-12
Start date
2013-09-30
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Adult

Interventions

Administer study drugs to subjects within 4 weeks. Administer placebo to subjects within 4 weeks.

Sponsors

Shiba Palace Clinic
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1) Japanese male who are equal or more than 50-year-old and less than 60-year-old when informed consent is obtained. 2) Subjects who get exhausted easily and cannot seem to shake the fatigue. 3) Subjects who go to the office on the day shift. 4) Subjects who live a well-regulated life rhythm.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
immune function

Secondary

MeasureTime frame
Intestinal microbiota analysis,Gene expression analysis,safety evaluation

Countries

Japan

Contacts

Public ContactKo MASUDA

SOUKEN Co., Ltd Management Division

k_masuda@mail.souken-r.com03-5408-1555

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026