UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062739 |
|---|---|
| Receipt number | R000071743 |
| Scientific Title | Potential immunomodulatory effects of acute red ginseng intake in healthy women of reproductive age across menstrual cycle phases: an exploratory single-blind crossover study |
| Date of disclosure of the study information | 2026/08/30 |
| Last modified on | 2026/08/30 17:22:13 |
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Basic information
Public title
Effects of acute red ginseng intake on immune function during the follicular and late luteal phases in healthy women
Acronym
Red ginseng and immune function study
Scientific Title
Potential immunomodulatory effects of acute red ginseng intake in healthy women of reproductive age across menstrual cycle phases: an exploratory single-blind crossover study
Scientific Title:Acronym
Red ginseng immunomodulatory crossover study
Region
| Japan |
Condition
Condition
Healthy women of reproductive age
Classification by specialty
| Obstetrics and Gynecology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Salivary secretory immunoglobulin A (SIgA), salivary chromogranin A (CgA), heart rate variability (HRV), the Japanese version of the Daily Record of Severity of Problems (DRSP), and the Profile of Mood States Second Edition (POMS 2).
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
6
Purpose of intervention
Prevention
Type of intervention
| Food |
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).
Interventions/Control_3
A single 30-mL serving of water is administered during the follicular phase (days 5-11 from the onset of menstruation).
Interventions/Control_4
A single 30-mL beverage containing 6 g of red ginseng powder is administered during the late luteal phase (within 7 days before the onset of the next menstruation).
Interventions/Control_5
A single 30-mL beverage containing 3 g of red ginseng powder is administered during the late luteal phase (within 7 days before the onset of the next menstruation).
Interventions/Control_6
A single 30-mL serving of water is administered during the late luteal phase (within 7 days before the onset of the next menstruation).
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 45 | 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 sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Tamaki |
| Middle name | |
| Last name | Matsumoto |
Organization
Shitennoji University
Division name
Faculty of Education
Zip code
583-8501
Address
3-2-1 Gakuenmae Habikino Osaka
TEL
072-959-2249
tamaki@shitennoji.ac.jp
Public contact
Name of contact person
| 1st name | Tamaki |
| Middle name | |
| Last name | Matsumoto |
Organization
Shitennoji University
Division name
Faculty of Education
Zip code
583-8501
Address
3-2-1 Gakuenmae Habikino Osaka
TEL
072-959-2249
Homepage URL
tamaki@shitennoji.ac.jp
Sponsor or person
Institute
Shitennoji University
Institute
Department
Personal name
Tamaki Matsumoto
Funding Source
Organization
Japan Red Ginseng Research Association
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Shitennoji University
Address
3-2-1 Gakuenmae, Habikino, Osaka 583-8501, Japan
Tel
072-956-3345
chiiki_kenkyu@shitennoji.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
四天王寺大学
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 08 | Month | 30 | Day |
Related information
URL releasing protocol
Not publicly available
Publication of results
Unpublished
Result
URL related to results and publications
Not publicly available
Number of participants that the trial has enrolled
20
Results
Salivary SIgA showed significant main effects of red ginseng intake (p = 0.029) and time (p = 0.001), and a red ginseng intake x time interaction (p < 0.001). SIgA increased at 30 and 60 min after 6 g (both p < 0.001) and at 30 min after 3 g (p = 0.040). SIgA after 6 g was higher than after 3 g and water. CgA showed main effects of menstrual phase, red ginseng intake, and time, but patterns varied across conditions. HRV changes were limited, and psychological symptom scores decreased over time.
Results date posted
| 2026 | Year | 08 | Month | 30 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The final analysis included 14 healthy adult women with a mean age of 21.0 +/- 0.7 years and a mean menstrual cycle length of 29.8 +/- 3.5 days.
Participant flow
Twenty-four women were screened, and 20 provided written informed consent to participate. Six participants withdrew before study completion, and 14 participants who completed all six trials were included in the final analysis.
Adverse events
No adverse events were observed.
Outcome measures
Salivary SIgA and CgA, heart rate variability (HRV), DRSP-JAPAN, and POMS 2
Plan to share IPD
Data will be shared upon reasonable request.
IPD sharing Plan description
The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.
Progress
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 |
Date of closure to data entry
| 2023 | Year | 08 | Month | 22 | Day |
Date trial data considered complete
| 2024 | Year | 02 | Month | 25 | Day |
Date analysis concluded
| 2026 | Year | 08 | Month | 19 | Day |
Other
Other related information
Management information
Registered date
| 2026 | Year | 08 | Month | 30 | Day |
Last modified on
| 2026 | Year | 08 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071743
