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

Not Applicable

Completed

• Conditions: Not Applicable

• Registration Number: KCT0006840
• Lead Sponsor: Ewha Womens University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2023-05-27
• Last Update Posted: 13 November 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 80

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

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

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assessment of stress and tension using a visual analogue scale

Secondary Outcome Measures

Name	Time	Method
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)