• 생물정신의학
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• 제22권2호
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• pp.63-77
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• 2015

Objectives The combination extract of four kinds of herbs, Gastrodia elata, Liriope platyphylla, Dimocarpus longan, and Salvia miltiorrhiza, has shown to have memory improving effects in mice. The aim of this study was to investigate the efficacy and safety of the herbal mixture for improving working memory as well as microstructural changes in white matter integrity in individuals with subjective memory complaints. Methods Seventy-five individuals with subjective memory complaints were assigned to receive either placebo (n = 15) or herbal mixture (low-dose group, n = 30 and high-dose group, n = 30) supplementation in an 8-week, randomized, double-blind, placebo-controlled clinical trial. Changes in working memory performance and fractional anisotropy (FA) values reflecting white matter integrity from baseline to 8-week endpoint were assessed. Results The herbal mixture group showed an increase in working memory performance compared to the placebo group (p for interaction = 0.001). In addition, the herbal mixture group showed an increase in FA values in the temporo-parietal regions (corrected p < 0.05), which are crucially involved in working memory function and are among the most affected regions in patients with cognitive impairments. Conclusions Findings from this study indicate that the herbal mixture may be a promising therapeutic option for individuals with subjective memory complaints.

• Journal of Ginseng Research
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• 제42권1호
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• pp.90-97
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• 2018

Background: Antihyperglycemic effects of Panax ginseng berry have never been explored in humans. The aims of this study were to assess the efficacy and safety of a 12-wk treatment with ginseng berry extract in participants with a fasting glucose level between 100 mg/dL and 140 mg/dL. Methods: This study was a 12-wk, randomized, double-blind, placebo-controlled clinical trial. A total of 72 participants were randomly allocated to two groups of either ginseng berry extract or placebo, and 63 participants completed the study. The parameters related to glucose metabolism were assessed. Results: Although the present study failed to show significant antihyperglycemic effects of ginseng berry extract on the parameters related to blood glucose and lipid metabolism in the total study population, it demonstrated that ginseng berry extract could significantly decrease serum concentration of fasting glucose by 3.7% (p = 0.035), postprandial glucose at 60 min during 75 g oral glucose tolerance test by 10.7% (p = 0.006), and the area under the curve for glucose by 7.7% (p = 0.024) in those with fasting glucose level of 110 mg/dL or higher, while the placebo group did not exhibit a statistically significant decrease. Safety profiles were not different between the two groups. Conclusion: The present study suggests that ginseng berry extract has the potential to improve glucose metabolism in human, especially in those with fasting glucose level of 110 mg/dL or higher. For a more meaningful benefit, further research in people with higher blood glucose levels is required.

• 대한한방내과학회지
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• 제27권4호
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• pp.836-844
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• 2006

Background: Mahuang (Ephedra sinica STAPF) is well known as an herbal medicine and has been widely used to reduce body weight and increase athletic ability. However, as a result of reporting many cases of adverse effects on the cardiovascular system, use of dietary supplements containing ephedra was prohibited by the FDA. Objectives : The object of this study was to find the effectiveness of ephedra on weight loss without severe adverse effect. Methods : 16 healthy volunteers consisting of an ephedra group (N=8) and a placebo group (N=8) were investigated. Study form was a randomized, controlled, double-blind clinical trial. The ephedra group took 12g of ephedra while the placebo group took 12g of glutinous rice powder. Both groups were measured with BCA (body composition analysis) on weight loss and with HRV (heart rate variability) on its adverse effect before and after medication. Results : The following results were obtained after taking 12g of ephedra for 14 days. In the ephedra group, body weight reduced significantly. In the placebo group, there were no significant differences of body weight between before and after placebo treatment. There was a slight increase of heart beat rate and deactivation of cardiac activity. Parasympathetic nerves were deactivated, but balances of autonomic nervous system were well maintained. Conclusions : The results suggest that ephedra in healthy adults tends to reduce body weight and deactivation of autonomic nervous system and cardiac activity.

• Journal of Ginseng Research
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• 제38권4호
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• pp.239-243
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• 2014

Background: To investigate the antidiabetic effects of hydrolyzed ginseng extract (HGE) for Korean participants in an 8-wk, randomized, double-blinded, placebo-controlled clinical trial. Methods: Impaired fasting glucose participants [fasting plasma glucose (FPG) ${\geq}5.6mM$ or < 6.9mM who had not been diagnosed with any disease and met the inclusion criteria were recruited for this study. The 23 participants were randomly divided into either the HGE (n = 12, 960 mg/d) or placebo (n = 11) group. Outcomes included measurements of efficacy (FPG, postprandial glucose, fasting plasma insulin, postprandial insulin, homeostatic model assessment-insulin resistance, and homeostatic model assessment-${\beta}$) and safety (adverse events, laboratory tests, electrocardiogram, and vital signs). Results: After 8 wk of HGE supplementation, FPG and postprandial glucose were significantly decreased in the HGE group compared to the placebo group. No clinically significant changes in any safety parameter were observed. Our study revealed that HGE is a potent antidiabetic agent that does not produce noticeable adverse effects. Conclusion: HGE supplementation may be effective for treating impaired fasting glucose individuals.

• The Korean Journal of Pain
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• 제33권1호
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• pp.40-47
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• 2020

Background: Duloxetine is an antidepressant that is also useful in chronic neuropathic and central origin pain. In this study, the role of duloxetine in decreasing acute postoperative pain after lumbar canal stenosis surgery is explored. Methods: In this single center, triple blinded, and placebo-controlled trial, 96 patients were randomized for statistical analysis. The intervention group received oral duloxetine 30 mg once a day (OD) for 2 days before surgery, 60 mg OD from the day of surgery to the postoperative second day and 30 mg OD for the next 2 days (a total duration of 7 days). A placebo capsule was given in the other group for a similar time and schedule. The same standard perioperative analgesia protocols were followed in both groups. Results: Total morphine consumption up to 24 hours was significantly decreased in the duloxetine group (P < 0.01). The time to the first analgesia requirement was similar in both groups but the time to the second and third dose of rescue analgesia increased significantly in the duloxetine group. The time to ambulation was decreased significantly (P < 0.01) in the duloxetine group as compared to the placebo group. Pain scores remained similar during most of the time interval. No significant difference was observed in the complication rate and patient satisfaction score recorded. Conclusions: Duloxetine reduces postoperative pain after lumbar canal stenosis surgery with no increase in adverse effects.

• 대한한방소아과학회지
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• 제33권4호
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• pp.37-46
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• 2019

Objectives The purpose of this study is to confirm the efficacy and safety of the treatment of with fermented oyster extract on height growth in children with short stature. Methods A total of 100 people, between 6 and 11 years old, will be participated in a randomized, double-blind, and placebo-controlled human study. The fermented oyster group will take 500 mg of fermented oyster extract once a day for 24 weeks. The placebo group will take 3400 mg of fructooligosaccharide as placebo once a day for 24 weeks. The outcomes of the intervention will be measured at the baseline, 6 week, 12 week, 18 week, and 24 week. The primary outcome is the changes in height from the baseline. The secondary outcomes are growth rate, height SDS, bone age, GH, IGF-1, IGFBP-3, osteocalcin, BALP, DPD, and LH. Results This trial was approved by the institutional review board of Pusan National University Korean Medicine Hospital (registry number: PNUKHIRB-2019002). Recruitment of the research participants will be opened from May 2019 till December 2019. Conclusions This study will provide clinical information to determine the efficacy and safety of the treatment with fermented oyster extract on height growth in children with short stature.

• Journal of Ginseng Research
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• 제39권1호
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• pp.7-13
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• 2015

Background: Many patients with glaucoma have difficulty using antiglaucoma eye drops because of dry eye symptom. In this prospective, randomized, double-blind, placebo-controlled study, we evaluated the effect of Korean Red Ginseng on dry eye syndrome in patients with glaucoma treated with antiglaucoma eye drops. Methods: Forty-nine participants were allocated to the Korean Red Ginseng (3 g/day; n = 24) or placebo (n = 25) groups for 8 weeks. Tear film stability, fluorescein corneal staining, conjunctival hyperemia, tear production, grade of meibomian gland dysfunction, and dry eye questionnaire (Ocular Surface Disease Index) were evaluated at baseline and on completion of the treatment. Results: Almost all patients displayed dry eye symptoms and signs at baseline. After the 8-week intervention, Korean Red Ginseng supplementation significantly improved the tear film stability and total Ocular Surface Disease Index score, as compared to placebo (p < 0.01). Conclusion: Korean Red Ginseng supplementation may provide an additional treatment option for dry eye and patients with glaucoma using antiglaucoma eye drops.

• Fisheries and Aquatic Sciences
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• 제25권8호
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• pp.450-461
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• 2022

A randomized, double-blind, and placebo-controlled clinical study was used to determine the cognitive functions related to working memory (WM) and antioxidant properties of fermented Laminaria japonica (FLJ) on healthy volunteers. Eighty participants were divided into a placebo group (n = 40) and FLJ group (n = 40) that received FLJ (1.5 g/day) for 6 weeks. Memory-related blood indices (brain-derived neurotrophic factor, BDNF; angiotensin-converting enzyme; human growth hormone, HGH; insulin-like growth factor-1, IGF-1) and antioxidant function-related indices (catalase, CAT; malondialdehyde, MDA; 8-oxo-2'-deoxyguanosine, 8-oxo-dG; thiobarbituric acid reactive substances, TBARS) were determined before and after the trial. In addition, standardized cognitive tests were conducted using the Cambridge Neuropsychological Test Automated Batteries. Furthermore, the Korean Wechsler Adult Intelligence Scale (K-WAIS)-IV, and the Korean version of the Montreal Cognitive Assessment (MoCA-K) were used to assess the pre and post intake changes on WM-related properties. According to the results, FLJ significantly increased the level of CAT, BDNF, HGH, and IGF-1. FLJ reduced the level of TBARS, MDA, and 8-oxo-dG in serum. Furthermore, FLJ improved physical activities related to cognitive functions such as K-WAIS-IV, MoCA-K, Paired Associates Learning, and Spatial Working Memory compared to the placebo group. Our results suggest that FLJ is a potential candidate to develop functional materials reflecting its capability to induce antioxidant mechanisms together with WM-related indices.

• Journal of Acupuncture Research
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• 제39권3호
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• pp.202-212
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• 2022

Background: The aim of this study was to evaluate the effectiveness and safety of Cheong-A-Won Gagambang (JCE003) treatment for degenerative knee osteoarthritis. Methods: This was a single-center, randomized, double-blind, placebo-controlled pilot clinical trial. There were 36 adults with degenerative knee osteoarthritis who were randomly allocated into JCE003 1,000 mg, JCE003 2,000 mg, or the placebo group (in a 1:1:1 ratio). The participants received 12 weeks of treatment and had scheduled tests every 6 weeks. The primary outcomes were measured using the Korean Western Ontario and McMaster Universities scale, and the secondary outcomes were measured using the visual analog scale, European quality of life-5-dimensions, patient global impression of change, C-reactive protein, and erythrocyte sedimentation rate. Changes between baseline scores and scores following study completion were analyzed. Results: There were 29 participants whose data were analyzed in this study. The change of Korean Western Ontario and McMaster Universities, visual analog scale, European quality of life-5-dimensions scores showed significant improvement in the JCE003 1,000 mg group. The change of patient global impression of change was significantly improved in the placebo group. There were 14 adverse events, but there was no clinically significant relationship with the intake of JCE003 compared with the placebo. Conclusion: Taking JCE003 may be effective at improving knee pain in patients with degenerative knee osteoarthritis and appears to be safe. Based on this study, the concentration and feasibility of the test group may be used when conducting a large-scale clinical trial of degenerative knee osteoarthritis in the future.

• Nutrition Research and Practice
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• 제17권5호
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• pp.883-898
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• 2023

BACKGROUND/OBJECTIVES: Probiotics have been suggested as potent modulators of age-related disorders in immunological functions, yet little is known about sex-dependent effects of probiotic supplements. Therefore, we aimed to investigate sex-dependent effects of probiotics on profiles of the gut microbiota and peripheral immune cells in healthy older adults. SUBJECTS/METHODS: In a randomized, double-blind, placebo-controlled, multicenter trial, healthy elderly individuals ≥ 65 yrs old were administered probiotic capsules (or placebo) for 12 wk. Gut microbiota was analyzed using 16S rRNA gene sequencing and bioinformatic analyses. Peripheral immune cells were profiled using flow cytometry for lymphocytes (natural killer, B, CD4⁺ T, and CD8⁺ T cells), dendritic cells, monocytes, and their subpopulations. RESULTS: Compared with placebo, phylum Firmicutes was significantly reduced in the probiotic group in women, but not in men. At the genus level, sex-specific responses included reductions in the relative abundances of pro-inflammatory gut microbes, including Catabacter and unclassified_Coriobacteriales, and Burkholderia and unclassified Enterobacteriaceae, in men and women, respectively. Peripheral immune cell profiling analysis revealed that in men, probiotics significantly reduced the proportions of dendritic cells and CD14⁺ CD16^- monocytes; however, these effects were not observed in women. In contrast, the proportion of total CD4⁺ T cells was significantly reduced in women in the probiotic group. Additionally, serum lipopolysaccharide-binding protein levels showed a decreasing tendency that were positively associated with changes in gut bacteria, including Catabacter (ρ = 0.678, P < 0.05) and Burkholderia (ρ = 0.673, P < 0.05) in men and women, respectively. CONCLUSIONS: These results suggest that probiotic supplementation may reduce the incidence of inflammation-related diseases by regulating the profiles of the gut microbiota and peripheral immune cells in healthy elders in a sex-specific manner.