Tokyo, Aug. 31 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062739) titled 'Effects of acute red ginseng intake on immune function during the follicular and late luteal phases in healthy women' on Aug. 30.
Study Type:
Interventional
Study Design:
Basic Design - Cross-over
Randomization - Randomized
Blinding - Single blind -participants are blinded
Control - Dose comparison
Primary Sponsor:
Institute - Shitennoji University
Condition:
Condition - Healthy women of reproductive age
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - This study aimed to investigate the acute effects of red ginseng intake on psychological states, neuroendocrine function, and immune responses in healthy women of reproductive age and to examine whether these effects vary according to dose and menstrual cycle phase.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - A single 30-mL beverage containing 6 g of red ginseng powder is administered during the follicular phase (days 5-11 from the onset of menstruation).
Interventions/Control_2 - A single 30-mL beverage containing 3 g of red ginseng powder is administered during the follicular phase (days 5-11 from the onset of menstruation).
Eligibility:
Age-lower limit - 20
years-old
=
Gender - Female
Key inclusion criteria - Women aged 20-45 years with regular menstrual cycles (25-38 days).
Key exclusion criteria - Women with medical, gynecological, or psychiatric disorders; those with a smoking habit; and those using oral contraceptives or regularly taking medications were excluded.
Target Size - 60
Recruitment Status:
Recruitment status - Completed
Date of protocol fixation - 2021 Year 10 Month 28 Day
Date of IRB - 2021 Year 10 Month 29 Day
Anticipated trial start date - 2021 Year 11 Month 12 Day
Last follow-up date - 2023 Year 04 Month 29 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071743
Disclaimer: Curated by HT Syndication.
