Human study to evaluate the efficacy and safety of ginseng for relieving stress and tension

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0006840

Enrollment

Registered

2021-12-17

Start date

2022-02-10

Completion date

Unknown

Last updated

2023-11-13

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

Conditions

None listed

Interventions

Dietary Supplement : Eligibility of the individuals who have signed the informed consent form will be screened according to the inclusion and exclusion criteria on visit 1. After 2-week run-in period,

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Volunteers who have signed the informed consent form 2. Individuals who are between the ages of 20 and 60 3. Reported stress and tension symptoms on psychiatric interview and self-report questionnaire (scoring more than 50% on the visual analog scale)

Exclusion criteria

Exclusion criteria: 1. Diagnosed with any major medical conditions requiring active treatment assessed during medical history taking, physical examination or experimental tests 2. Diagnosed with dementia or any cognitive disorders 3. Any contraindications to magnetic resonance imaging 4. Had taken psychotropic drugs or sleep medications within the past 3 months prior to enrollment 5. Had continually consumed any types of ginseng, ginseng-containing products, or health functional foods that could affect relief of tension within the past 1 month prior to enrollment 6. Participated in other clinical trials within the past 1 month prior to enrollment 7. Planning for pregnancy during the study participation, currently pregnant or breastfeeding 8. Hypersensitivity to ingredients of ginseng or placebo, or had experience severe food allergies 9. Judged inappropriate to participate the study by the researcher

Design outcomes

Primary

Measure	Time frame
Assessment of stress and tension using a visual analogue scale	—

Secondary

Measure	Time frame
Assessment of stress and tension using self-report instruments and interviews;Neurophysiological test (heart rate variability, skin conductance response);Blood cortisol level;Multimodal brain magnetic resonance imaging data;Neuropsychological test (Cambridge Neuropsychological Test Automated Battery, paper and pencil test);Safety marker (blood and urine tests, adverse effect)	—

Countries

Korea, Republic of

Contacts

Public ContactEunji Ha

Ewha Womens University

eunji.i.ha@gmail.com+82-2-3277-6556

Outcome results