• The Journal of Internal Korean Medicine
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• v.28 no.2
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• pp.346-353
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• 2007

Background : Over a thousand years of clinical preparation of Ephedrain traditional Korean medicine has confirmed effectiveness and security. Recently. Ephedra-containing herbal preparations to treat obesity are common. The aim of this study is to identify effects of Ephedra on psychological anxiety. Objectives : To determine effects of Ephedraon psychoactivity and autonomic nervous system. Methods : The study design was a double-blind randomized controlled trial. The subjects of this study were healthy adults. They were allocated to either the Ephedragroup (N =66) or the placebo group (N =32), Ephedra(8 g) or a placebo in similar opaque capsules was given twice a day for 2 weeks. Anxiety score was estimated with State-Trait Anxiety Inventory before first and after last medication. 36 of the Ephedragroup and 24 of the placebo group finished the trial and were analyzed. Paired samples T-test and independent samples T-test were applied to statistical analysis. Results : The following result was obtained: After taking Ephedra. state anxiety increased significantly. In the placebo group. both state and trait anxiety increased although significance was not reached. Conclusions : It is concluded that the intake of Ephedraplays a significant role in the increase of anxiety in healthy adults. It is suggested that anxiety level change should be considered when using Ephedra in clinics.

• 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.

• 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.

• Nutrition Research and Practice
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• v.17 no.4
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• pp.698-716
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• 2023

BACKGROUND/OBJECTIVES: The aim of this study was to evaluate the sensory properties of antioxidant-rich bread made by adding pomegranate peels and their effects on anthropometric measurements and metabolic and oxidative parameters of individuals with type 2 diabetes after consumption. SUBJECTS/METHODS: This randomized, double-blind, placebo-controlled study was conducted with 22 individuals aged between 19 and 64 years who had been diagnosed with type 2 diabetes for at least 5 years, used only metformin, did not lose more than 10% of their body weight in the last 6 months, and had a body mass index of ≥ 25.0 kg/m². While the study group (n = 11) consumed bread containing 500 mg pomegranate peel daily for 8 wk, the control group (n = 11) consumed standard bread. Anthropometric measurements and metabolic and oxidative parameters of individuals were evaluated at the beginning and end of the study. RESULTS: Decreases were detected in the waist circumference, waist/hip and waist/height ratios, body fat percentages, blood pressure, and serum insulin, triglyceride, and total cholesterol levels in the individuals in the treatment group, compared with those in the control group (P < 0.05). CONCLUSIONS: Pomegranate peel consumption by individuals with type 2 diabetes may have positive effects on anthropometric measurements and glycemic and lipid parameters.

• The Journal of Internal Korean Medicine
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• v.32 no.4
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• pp.542-549
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• 2011

Objectives : The present study was made to evaluate the clinical effectiveness of Saengmaeg-san (生脈散) extract to treat xerostomia in stroke patients. Methods : The study design was a double-blind randomized controlled trial. Subjects were stroke patients with xerostomia. They were allocated to either the Saengmaeg-san (n=12) or placebo group (n=12). Saengmaeg-san extract or a placebo in similar opaque capsules was given three times a day for a week. The improvement of xerostomia was measured by the xerostomia-evaluating questionnaire, developed by the school of dentistry in Seoul National University, before baseline and one week later. Eleven of the Saengmaeg-san group and ten of the placebo group finished the trial and were analyzed. Paired samples t-test and Mann-Whitney test were applied to statistical analysis. Results : On three of the six questions, the Saengmaeg-san group improved significantly. On two of the six questions, the Saengmaeg-san group improved significantly more than the placebo group. On the other questions, the Saengmaeg-san group improved more than the placebo group, although significance was not reached. Conclusions : These results demonstrate that Saengmaeg-san extract is effective for treating xerostomia in stroke patients, and further studies should be conducted to provide more valuable information.

• Nutrition Research and Practice
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• v.10 no.2
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• pp.175-181
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• 2016

BACKGROUND/OBJECTIVES: The anti-obesity effect of quercetin-rich onion peel extract (OPE) was suggested in rats, but information from human studies is limited. This study aimed to investigate the effects of OPE on the body composition of overweight and obese subjects. MATERIALS/METHODS: In this 12-week, randomized, double-blind, placebo-controlled study, parallel clinical trials were performed in overweight and obese Korean subjects. Randomly assigned subjects were instructed to take daily either the placebo (male, 6 and female, 30) or OPE capsules containing 100 mg of quercetin (male, 5 and female, 31). Body composition was measured by using bioimpedance and dual-energy X-ray absorptiometry (DXA). Resting energy expenditure (REE) and respiratory quotient (RQ) were evaluated by using indirect calorie measurement methods. Fasting blood levels of glucose, insulin, lipids, and leptin were determined. RESULTS: Quercetin-rich OPE supplementation significantly reduced the weight and percentage of body fat as measured by DXA (P = 0.02). These effects were not shown in the control group. Levels of blood glucose (P = 0.04) and leptin (P = 0.001 for placebo, P = 0.002 for OPE) decreased in both groups. Significant increases in REE and RQ were observed in both groups (P = 0.003 for placebo, P = 0.006 for OPE) and in the OPE group alone (P = 0.02), respectively. CONCLUSIONS: Quercetin-rich OPE supplementation changed the body composition of the overweight and obese subjects. This result suggests a beneficial role of the anti-obesity effect of OPE human subjects.

• Journal of Sasang Constitutional Medicine
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• v.30 no.2
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• pp.42-54
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• 2018

Objectives This study was aimed to compare effects of Yukgunja-tang (YGJT) extract granule on functional dyspepsia (FD) by sasang constitution. Methods A placebo-controlled, double-blind, randomized, two-center trial was performed. We obtained 3D face images of FD patients participating in this study using face-only scanner and classified them into two types as narrow face and wide face by 3D facial shape diagnosis system (3-FSDS). 96 subjects (48 subjects per type) were enrolled and were randomly allocated into treatment or control groups in a 2:1 ratio. YGJT extract granule or placebo were administered to each group during the 8 week treatment period. One of sasang constitutional specialist diagnosed their constitutions by referring to questionnaires and 3D face images. The primary outcome was total dyspepsia symptom scale (TDS scale), the secondary outcomes were single dyspepsia symptom scale (SDS scale), visual analog scale (VAS) and so on. This trial was registered with clinical research information service identifier: KCT0001920, 15 May, 2016. Results In the Taeeumin treatment group, the TDS scale was significantly decreased after 8 weeks compared to the control group (t=2.331, p=0.025) and the SDS scale also significantly decreased. (t=2.042, p=0.048). The specific effects of the YGJT extract granule without the placebo effect on the Taeeumin with functional dyspepsia were 30.61% in TDS scale and 28.33% in SDS scale. Conclusions The effects of Yukgunja-tang extract granule on functional dyspepsia was different according to Sasang constitution. So the constitution should be considered in randomized controlled trials using herbal extract granules.

• Nutrition Research and Practice
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• v.10 no.3
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• pp.364-364
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• 2016

• The Korean Journal of Pain
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• v.35 no.3
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• pp.311-318
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• 2022

Background: Ketamine is widely used in infants and young children for procedural sedation and anesthesia. The aim of this study was to evaluate the efficacy and safety of low dose oral ketamine to control pain and distress in children during intravenous (IV) cannulation. Methods: This is a prospective, randomized, double-blind study, including children aged between 3 and 6 years requiring a non-emergent IV-line placement. Children were randomly assigned to two groups, treated either with oral ketamine or a placebo. All patients were monitored for vital signs. Pain was assessed using the Children's Hospital of Eastern Ontario Pain Scale (CHEOPS) and Wong-Baker Faces Pain Rating Scale (WBFS) scales and sedation using a 5-point sedation score. The facility of IV-line placement was measured by a 3-point scale. Adverse effects were recorded after 1 and 24 hours. Results: A total of 79 and 81 children were entered in the ketamine and placebo groups, respectively. The heart and respiratory rates increased significantly in the placebo group. The median CHEOPS 4 (95% confidence interval [CI]: 3, 4, P < 0.001) and WBFS 6 (95% CI: 4, 6, P < 0.001) scores decreased statistically in the ketamine group. IV-line placement was 50% easier in the ketamine group (95% CI: 37%, 63%, P < 0.001). No serious adverse effects were observed in all cases. Conclusions: Low dose oral ketamine effectively decreased the pain and distress during IV cannulation in children without any significant adverse reactions.

• The Journal of Korean Medicine
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• v.24 no.2
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• pp.109-120
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• 2003

Objectives: This study was conducted to evaluate the clinical efficacy of EC102, a composition containing oriental medicine, for relieving VDT syndrome, including eye symptoms and musculo-skeletal symptoms. Methods: The study was conducted by using a double blind randomized controlled trial design. 40 subjects were randomly assigned to the placebo group or the EC102 group. The visual analogous scale (VAS) was used to evaluate various VDT symptoms, including eye pain, eye fatigue, back pain, shoulder pain and so on. Refractory indexes were measured using refractometer, and tear film break-up time (BUT) were measured using fluorescein strip. Blood circulation was measured using photo-plethysmography. Blood pressure and blood biochemistry were also measured. Statistical analysis was conducted by a Mann-Whitney test using SPSS 9.0 software. Results: The EC102 group showed a statistically significant reduction of eye symptoms including eye fatigue, eyelid fatigue, itching, pain, and photophobia when compared with the placebo group (P<0.05). The EC102 group also showed a statistically significant reduction of back pain compared with the placebo group (P<0.05). No side effects on liver function and blood biochemistry were observed. Conclusions: EC102 has significant clinical efficacy for relieving symptoms of VDT syndrome.