None listed
Conditions
Interventions
Dietary Supplement : Take a black ginseng extract or a red ginseng extract or placebo for 6 weeks, 3 capsules twice a day with water (total 2 g)
Sponsors
Kyung Hee University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Subjects who agree to participate in this study and have given their written informed consent 2) Men and women aged 20 to under 65, excluding an illiterate
Exclusion criteria
Exclusion criteria: 1) Present or previous significant allergy to any health supplements and medicine, including ginseng 2) History or presence of any clinically significant medical condition such as dementia, brain tumor, hydrocephalus. 3) History or presence of clinically significant medical condition such as stroke, heart disease (heart failure, angina, myocardial infarction), malignant disease, narrow angle glaucoma, resistant hypertension, lung disease. 4) Subjects who have clinical manifestation associated renal or hepatic disorders (serum creatinine > 2.0 mg/dL, liver function test: ALT, AST > 2.5 times of the upper limit of normal range) 5) Subjects who show the following results; - Fasting blood glucose ? 160 mg/dL, despite of taking oral antidiabetic agents - Platelet ? 150,000/mm3, WBC ? 4,000/mm3, Hemoglobin ? 9.5 g/dL for men or ? 9.0 g/dL for women 6) Use of the medications or products such as oral steroid, hormones within 3 months prior to the scheduled study drug administration. 7) Subjects who have been taking medication or functional food, known to interfere with the absorption, metabolism and elimination of study drug (test food) or Subjects who participated in any other clinical trial within 3 months prior to the scheduled study drug administration 8) Subjects who have undergone surgical procedures within 6 months prior to the scheduled study drug administration or who have are taking medications such as herbal supplements (ginseng) or herbal medicine within 1 months prior to the scheduled study drug administration 9) Any condition possibly affecting drug absorption such as gastrectomy 10) Pregnant women, lactating women, or unable to take effective contraceptive measures (oral contraceptive pills, birth control implants, intrauterine devices, condoms, spermicides) 11) Donation of a unit of blood within two months, or of blood components within one month, or receipt of blood transfusion within one month before the first administration of the study drug 12) Subjects who do not follow informed-consent rules, or who are judged by the investigator to be inappropriate for inclusion in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in craniocervical area temperature | — |
Secondary
| Measure | Time frame |
|---|---|
| Inflammation index(hs-CRP, IL-6);Changes in biomarkers;Chalder fatigue changes | — |
Countries
Korea, Republic of
Contacts
Public ContactKEUM-RAN JEONG
Kyung Hee University Hospital
Outcome results
None listed