• Journal of Ginseng Research
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• v.46 no.4
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• pp.585-591
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• 2022

Background: Korean Red Ginseng (KRG) extract has been shown to have beneficial effects in patients with atherosclerosis, suggesting that KRG extract may be effective in preventing subsequent ischemic stroke in patients with severe atherosclerosis. Methods: This double-blind, placebo-controlled trial randomized patients with severe atherosclerosis in major intracranial arteries or extracranial carotid artery, to ginseng group and placebo group. They were given two 500-mg KRG tablets or identical placebo tablets twice daily for 12 months according to randomization. The primary endpoint was the composite of cerebral ischemic stroke and transient ischemic attack during 12 months after randomization. The secondary endpoints were change in volumetric blood flow of the intracranial vessels and the incidence of newly developed asymptomatic ischemic lesions. Any adverse events were monitored. Results: Fifty-eight patients were randomized from June 2016 to June 2017, 29 to ginseng and 29 to placebo, and 52 (28 and 24, respectively) completed the study. One patient in the placebo group, but none in the ginseng group, experienced ischemic symptoms (p = 0.46). Changes in volumetric blood flow and the presence of ischemic brain lesions did not differ significantly in the two groups, and none of these patients experienced adverse drug reactions. Conclusion: Ginseng was well tolerated by patients with severe atherosclerosis, with these patients showing good compliance with ginseng dosing. Ginseng did not show significant effects compared with placebo, although none of the ginseng-treated patients experienced ischemic events. Long-term studies in larger patient populations are required to test the effect of ginseng.

• Journal of Ginseng Research
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• v.46 no.4
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• pp.543-549
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• 2022

Background: In physical activity or labor, the human body is in a state of high intensity stress, and all parts or physiological functions of the body respond positively to maintain or balance the need for movement. The human body has many physiological changes in the process of movement, and fatigue is the external manifestation of various complex changes inside the human body. Fatigue is also a physiological mechanism of self-protection after the body reaches a certain level of activity, which can prevent the occurrence of life-threatening excessive functional failure. The generation of fatigue is a very complex process, and its mechanism has not been concluded yet. Therefore, it is an important work to search and screen the effective components of natural plants that have anti-fatigue effect and to explore their mechanism. Methods: This was a 8-week, randomized, double-blind, placebo-controlled clinical trial. A total of 110 subjects who passed physical examination were included according to the scheme design, and randomly divided into a test group which was given KRG and a placebo control group. The calculation is carried out according to the standard of sub-high-intensity exercise test. Results: There was no adverse effect on safety index of subjects after taking red ginseng capsule. After KRG treatment, subjective strength grade is significant lower than placebo treatment. Blood lactic acid content is significantly get lower after trial in KRG group, and significant lower than placebo group. Creatine phosphokinase(CK) content is significantly get lower after trial in KRG group, and significant lower than placebo group. Conclusion: According to the criterion in the test scheme, the result shows that KRG is helpful on relieving physical fatigue.

• Journal of Ginseng Research
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• v.46 no.4
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• pp.601-608
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• 2022

Background: Various treatments are used to relieve menopausal symptoms for women. However, herbal substances are frequently used as complementary and alternative therapies as other treatments can increase ovarian and breast cancer risk. While the herbal substances' therapeutic effect is essential, the safety of their use is considered more important. This study aims to confirm the safety of red ginseng and herb extract complex (RHC), which are used to relieve menopausal symptoms. Methods: This randomized, double-blind, placebo-controlled clinical study recruited and divided 120 women experiencing menopausal symptoms into the RHC and placebo groups (60 women per group). Subjects were administered with 2 g RHC or placebo daily for 12 wk. Adverse reactions, female hormonal changes, and uterine thickness were observed and recorded on wk 0, 6, and 12. Hematologic and blood chemistry tests were also conducted. Results: The reactions of the subjects who received RHC or placebo at least once were analyzed. A total of six adverse reactions occurred in the RHC group, while nine occurred in the placebo group; common reactions observed in both groups were genital, subcutaneous tissue, and vascular disorders. However, there was no statistically significant difference between the administration groups (p = 0.5695), and no severe adverse reactions occurred in both groups.

• Journal of Audiology & Otology
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• v.24 no.1
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• pp.10-16
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• 2020

Background and Objectives:The blockage of adenosine receptors by caffeine changes the levels of neurotransmitters. These receptors are present in all parts of the body, including the auditory and vestibular systems. This study aimed to evaluate the effect of caffeine on evoked potentials using auditory brainstem responses (ABRs) and cervical vestibular-evoked myogenic potentials (cVEMPs) in a double-blind placebo-controlled study. Subjects and Methods: Forty individuals (20 females and 20 males; aged 18-25 years) were randomly assigned to two groups: the test group (consuming 3 mg/kg pure caffeine powder with little sugar and dry milk in 100 mL of water), and the placebo group (consuming only sugar and dry milk in 100 mL water as placebo). The cVEMPs and ABRs were recorded before and after caffeine or placebo intake. Results: A significant difference was observed in the absolute latencies of I and III (p<0.010), and V (p<0.001) and in the inter-peak latencies of III-V and I-V (p<0.001) of ABRs wave. In contrast, no significant difference was found in cVEMP parameters (P13 and N23 latency, threshold, P13-N23 amplitude, and amplitude ratio). The mean amplitudes of P13-N23 showed an increase after caffeine ingestion. However, this was not significant compared with the placebo group (p>0.050). Conclusions: It seems that the extent of caffeine's effects varies for differently evoked potentials. Latency reduction in ABRs indicates that caffeine improves transmission in the central brain auditory pathways. However, different effects of caffeine on auditory- and vestibular-evoked potentials could be attributed to the differences in sensitivities of the ABR and cVEMP tests.

• Korean Journal of Audiology
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• v.24 no.1
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• pp.10-16
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• 2020

Background and Objectives:The blockage of adenosine receptors by caffeine changes the levels of neurotransmitters. These receptors are present in all parts of the body, including the auditory and vestibular systems. This study aimed to evaluate the effect of caffeine on evoked potentials using auditory brainstem responses (ABRs) and cervical vestibular-evoked myogenic potentials (cVEMPs) in a double-blind placebo-controlled study. Subjects and Methods: Forty individuals (20 females and 20 males; aged 18-25 years) were randomly assigned to two groups: the test group (consuming 3 mg/kg pure caffeine powder with little sugar and dry milk in 100 mL of water), and the placebo group (consuming only sugar and dry milk in 100 mL water as placebo). The cVEMPs and ABRs were recorded before and after caffeine or placebo intake. Results: A significant difference was observed in the absolute latencies of I and III (p<0.010), and V (p<0.001) and in the inter-peak latencies of III-V and I-V (p<0.001) of ABRs wave. In contrast, no significant difference was found in cVEMP parameters (P13 and N23 latency, threshold, P13-N23 amplitude, and amplitude ratio). The mean amplitudes of P13-N23 showed an increase after caffeine ingestion. However, this was not significant compared with the placebo group (p>0.050). Conclusions: It seems that the extent of caffeine's effects varies for differently evoked potentials. Latency reduction in ABRs indicates that caffeine improves transmission in the central brain auditory pathways. However, different effects of caffeine on auditory- and vestibular-evoked potentials could be attributed to the differences in sensitivities of the ABR and cVEMP tests.

• Korean Journal of Exercise Nutrition
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• v.24 no.1
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• pp.29-36
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• 2020

[Purpose] The purpose of this study was to investigate the effects of short-term creatine intake on muscle fatigue induced by resistance exercise in healthy adolescent men, i.e., lactic acid concentration and wrist and head tremor measured by an accelerometer. [Methods] Twelve healthy adolescent men who had no experience with creatine intake were included. The subjects were randomly assigned to the creatine group and the placebo group, followed by 5 days of creatine and placebo intake, and 5 times of 5 sets of leg press, leg extension, bench press, and arm curl exercises at 70% repetition maximum (RM). The lactic acid concentration before and after exercising, rate of perceived exertion (RPE), and accelerometer-based wrist tremor and head tremor during exercise were measured. Subsequently, after 7 days to allow for creatine washout, the same exercise treatment and measurement were performed in each group after switching drug and placebo between the groups. [Results] The level of lactic acid before and after the acute resistance exercise trial was significantly lower in the creatine group than in the placebo group (P <0.05). The mean RPE during the resistance exercise was significantly lower in the creatine group than in the placebo group (P <0.05). There was no difference between the two groups in the mean wrist tremor during resistance exercise, but the mean head tremor values were significantly lower in the creatine group than in the placebo group in the arm curl, the last event of the exercise trials (P <0.05). [Conclusion] Short-term creatine intake reduces the blood fatigue factor increased by resistance exercise, and is thought to suppress fatigue, especially in the latter half of resistance exercise. Therefore, these findings indicate that short-term creatine intake can have an improved effect on anaerobic exercise performance.

• The Journal of Pediatrics of Korean Medicine
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• v.37 no.3
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• pp.121-132
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• 2023

Objectives We aimed to confirm whether Humulus japonicus Extract Powder can enhance child height growth significantly and safely compared with a placebo. Methods A total of 150 children between the 3rd and 25th percentiles in height and between the ages of 6 and 9 years will be recruited to participate in this randomized, double-blind, placebo-controlled clinical trial. The participants will be randomly assigned to the treatment or placebo group. Participants in the treatment group will take one pack per day (700 mg of Humulus japonicus Extract Powder) for 24 weeks. Participants in the placebo group will take one package of placebo per day (0 mg of Humulus japonicus Extract Powder) for 24 weeks. The primary outcome will be a change in height after 12 weeks, and the secondary outcomes will be the height after 24 weeks, growth rate, height standard deviation, growth hormone, insulin-like growth factor-1 (IGF-1), insulin-like growth factor binding protein-3 (IGFBP-3), bone alkaline phosphatase (BALP), and osteocalcin after 12 and 24 weeks. Results This protocol was approved by the Institutional Review Board (IRB) of the Korean Medicine Hospital of Busan University (IRB No. PNUKHIRB-2023-03-002). Research participants will be recruited from June 2023 to December 2023. Conclusions The results of this study provide clinical information regarding the effectiveness and safety of the Humulus japonicus Extract Powder in increasing child height.

• Journal of Ginseng Research
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• v.47 no.6
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• pp.735-742
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• 2023

Background: Gintonin is a new material of ginseng that acts through the ginseng-derived lysophosphatidic acid (LPA) receptor ligand. The gintonin-enriched fraction (GEF) inhibits amyloid plaque accumulation in the cortex and hippocampus, improves cognitive dysfunction by increasing acetylcholine levels, and promoted hippocampal neurogenesis in an animal model of Alzheimer's disease. We evaluated the effect of the GEF on the cognitive performance of subjects with subjective memory impairment (SMI). Methods: In this eight-week, randomized, assessor- and participant-blinded, placebo-controlled study, participants with SMI were assigned to three groups receiving placebo, GEF 300 mg/day or GEF 600 mg/day. The Korean versions of the Alzheimer's Disease Assessment Scale (K-ADAS), Mini-Mental State Examination (K-MMSE), and Stroop color-word test (K-SCWT) were also evaluated along with the safety profiles. Results: One hundred thirty-six participants completed the study. After eight weeks, we analyzed intergroup differences in primary or secondary outcome score changes. When we compared the GEF group with the placebo group, we observed significant improvements in the K-ADAS and K-SCWT scores. The GEF group did not show a significant improvement in K-MMSE and BDI scores compared to the placebo group. No adverse events were observed in the gintonin and placebo groups for eight weeks. Conclusion: The GEF is safe and effective in improving subjective cognitive impairment related to both the K-ADAS and K-SCWT in this study. However, further large-scale and randomized controlled studies are warranted to secure other cognitive function tests besides the K-ADAS and K-SCWT, and to confirm the findings of the current study.

• Nutrition Research and Practice
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• v.18 no.1
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• pp.33-45
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• 2024

BACKGROUND/OBJECTIVES: Onion, particularly onion peel, is a quercetin-rich food with, anti-inflammatory and immunomodulatory effects. However, the effect of onion peel extract (OPE) in humans is unclear. Thus, the present study aimed to investigate whether OPE improves natural killer (NK) cell activity and cytokine concentration in a randomized double-blind placebo-controlled trial. SUBJECTS/METHODS: Eighty participants aged 19-64 yrs old with a white blood cell count of 4,000-10,000 cells/µL, symptoms of upper respiratory infection at least once within the previous 12 mon, and perceived stress scale (PSS) over 14 were included. Participants were randomly assigned to take either 1,000 mg/day OPE or a placebo for 8 weeks. RESULTS: Compliance were 87.4 ± 8.6% and 86.9 ± 79.0% in OPE and placebo groups. Compared to the placebo, OPE supplementation improved "Hoarseness" (P = 0.038) of the Wisconsin Upper Respiratory Symptom Survey (WURSS)-21 symptom, and stress scores (P = 0.001; 0.021) of PSS. Supplementation of OPE had no significant effect on NK cell activity and concentrations of cytokines such as interleukin (IL)-2, IL-6, IL-12, IL-1β, interferon-γ, and tumor necrosis factor-α. At baseline, the WURSS-21 symptom and PSS score (P = 0.024; 0.026) were higher in the OPE group than the placebo group. Among participants with higher than median WURSS-21 symptom score, OPE supplementation increased NK cell activity (P = 0.038). Supplementation of OPE had no significant effects on safety measurements and adverse events. CONCLUSIONS: The present study suggested that OPE supplementation improves NK cell activity in participants with moderate upper respiratory symptoms without any significant adverse effects.

• Journal of Ginseng Research
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• v.42 no.4
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• pp.571-576
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• 2018

Background: Korean Red Ginseng (KRG) has been used in Asia for its various biological effects, but no studies have investigated the safety of its long-term intake. Therefore, the present study evaluated the safety of KRG intake for 24 weeks. Methods: We randomized 1,000 participants in a 1:1 ratio into two groups, which were treated daily with 2 g of KRG or a placebo for 24 weeks. The primary endpoint was all adverse events and adverse drug reactions (ADRs) that occurred after KRG or placebo administration, which were reported at week 4, 12, and 24 after the baseline visit. Results: In total, 192 and 211 participants experienced adverse events in the KRG and placebo groups (39.2% and 42.0%, respectively; p = 0.361), and 59 and 57 KRG- and placebo-treated individuals reported ADRs (12.0% and 11.4%, respectively; p = 0.737). The frequently occurring ADRs were pruritus (2.0%), headache (1.6%), diarrhea (1.4%), and dizziness (1.2%) in the KRG group and pruritus (2.0%), headache (1.8%), dizziness (1.6%), rash (1.4%), and diarrhea (1.2%) in the placebo group. Discontinuation of drug administration due to ADRs was reported in 13 participants, six (1.2%) and seven (1.4%) in the KRG and placebo groups, respectively (p = 0.814). No significant abnormal changes were revealed by anthropometric, laboratory, and vital sign measurements in the KRG group compared with those in the placebo group. Conclusion: The present study confirms the safety and tolerability of daily intake of 2 g of KRG for 24 weeks by healthy adults.