Effect of supplement on fatigue of adult males and females with feeling fatigue. -a randomized, double-blind, placebo-controlled study

Not Applicable

• Conditions: Healthy volunteer

• Registration Number: JPRN-UMIN000023821
• Lead Sponsor: Soiken Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-08-30
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Not provided

Exclusion Criteria

1)Subjects who are undergoing medication suffer from some sort of disease. 2)Subjects who are during pregnancy or lactation, and possibility of pregnancy during the study period. 3)Subjects who have alimentary allergy. 4)Subjects who have a intake habit of continued medicines, quasi-drugs, food with health claims (food for specified health use), health foods and supplements such currently or within the past three months, furthermore going to their intake during the study period. 5)Subjects who have previous history or present illness of cardiovascular disease, nephritis, hepatitis, pancreatitis, and so on. 6)Subjects who have previous history of serious disability of liver, kidney, heart, lung, blood, and so on. 7)Subjects who have comorbidity and previous history of digestive system. 8)Subjects who have diagnosis history or strongly suspected of insomnia, sleep apnea syndrome, depression and menopause. 9)Subjects who have diagnosis history of chronic fatigue syndrome or idiopathic chronic fatigue. 10)Subjects who systolic blood pressure is 140 mmHg or more, or diastolic blood pressure is greater than or equal to 90 mmHg at rest. 11)Subjects who are ingesting alcohol in excessive (alcohol in terms of 60 g or more per day). 12)Subjects who are planning to travel abroad or more than three days and two -nights of travel during the study period. 13)Subjects who are a blood donation of more than 200 mL in the past one month, or more than 400 mL in the past three months. 14)Subjects who are participating in other clinical trial or three months has not elapsed after joining other clinical trials. 15)Subjects who were deemed inappropriate to participate in the study by the investigator.

Study & Design

• Study Type: Interventional
• Study Design: Not specified