• 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.

• Fisheries and Aquatic Sciences
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• v.25 no.8
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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.

• 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 Pharmacopuncture
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• v.11 no.1
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• pp.21-29
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• 2008

Objectives : To investigate the therapeutic effects of SBVP in the treatment of patients with cancer-related pain. Design : A prospective randomized, double-blind, placebo-controlled study of SBVP. Setting : The study was conducted at the East West Cancer Center of Daejeon University Dunsan Oriental Hospital from March 1, 2007 to June 20, 2007. Patients : 11 patients diagnosed with cancer-related pain of over 3rd degree on the Numeric Rating Scale(NRS)(0, no pain at all, 10, worst pain imaginable) were entered into a double-blind, placebo-controlled trial of SBVP. They were randomized into Groups A and B(SBVP and control group, respectively) using the table of random sampling numbers and never informed of their affiliation by the coordinator. 5 of 6 patients in Group A and 4 of 5 patients in Group B completed the clinical trial. Intervention : SBVP(1ml/day) for group A and Normal Saline Placebo(1ml/day) for group B was injected into the abdomen acupoint, Zhong Wan(CV 12). The treatment was administered daily for five days. Outcome Measures : Degree of cancer-related pain was measured using the Numeric Rating Scale(NRS) before and after each treatment for "Pain right now" and "Average pain in last 24 hours". Statistical Analysis : Analysis regarding variations in NRS was carried out by applying t-tests(independent sample t-test and paired sample t-test) and Wilcoxon signed rank test with level of significance at 5%. Results : Differences in NRS of "Pain right now" for the two groups were statistically significant. The mean improvement point of SBVP was significantly higher than the control group($2.48^{\circ}{\pm}1.52$ vs $0.97^{\circ}{\pm}1.88$, p<0.05). Differences in average pain score before and after treatment in SBVP group were also significant($5.13^{\circ}{\pm}1.77$ vs $2.65^{\circ}{\pm}0.67$, p<0.05) compared with control group. The two groups showed no significant differences for long term effects in "Average pain in last 24 hours." Conclusion : Although further study will be needed on the large scale, SBVP shows potential as an effective treatment for immediate relief of cancer-related pain.

• Journal of Physiology & Pathology in Korean Medicine
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• v.18 no.2
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• pp.606-611
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• 2004

In East-South Asia it has been known that Korean ginseng(Panax ginseng) increases blood pressure, whereas American ginseng(Panax quinquefolius) doesn't. This study was designed to find out if Korean ginseng really could increase blood pressure comparing with American ginseng. Double-blind randomized controlled trials on blood pressure and pulse rate of Korean ginseng and American ginseng in Koreans and Chineses was performed. There was no significant difference on blood pressure and pulse rate between Korean ginseng and American ginseng in both Koreans and Chineses by repeated-measures ANOVA. It was revealed that Korean ginseng does not increase blood pressure. Maybe the concept that Korean ginseng increases blood pressure is concerned with commercial interests dealing with American Ginseng.

• Journal of Physiology & Pathology in Korean Medicine
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• v.17 no.3
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• pp.837-841
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• 2003

In East-South Asia it has been widely known that Korean ginseng(Panax ginseng) increases body temperature, whereas American ginseng(Panax quinquefolius) decreases it. This study was designed to find out if Korean ginseng could increase body temperature comparing with American ginseng. Double-blind randomized controlled trials on body temperature of Korean ginseng and American ginseng in Koreans and Chineses was performed by using electronic thermometer at the ear. There was no significant difference between Korean ginseng and American ginseng in Koreans as well as Chineses by repeated-measures ANOVA. It was revealed that Korean ginseng does not increase body temperature. Maybe the concept that Korean ginseng increase body temperature is concerned with commercial interests dealing with American Ginseng.

• Journal of Korean Medicine Rehabilitation
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• v.30 no.1
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• pp.105-113
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• 2020

Objectives Excess weight and obesity are a crucial public health problem worldwide and are considered as the main cause of many chronic diseases. The present study evaluated the effects of Aronia melanocarpa extract (AMEX) supplementation on body compositions in overweight or obese people. Methods This randomized, double-blind, placebo-controlled clinical trial was carried out on 66 healthy overweight or obese peoples. The eligible subjects were divided into AMEX and placebo supplement treatment for 12 weeks. Anthropometrics, body composition (dual-energy X-ray absorptiometry), and blood analysis were performed preand post intervention. Results We observed significant reductions in the body weight and body mass index in both groups; however, the decrease was higher in the AMEX group. Body fat mass and percent body fat showed a tendency to decreases after AMEX supplementation. No clinically significant changes were observed for any safety parameter. Conclusions In conclusion, the data of this trial indicate that AMEX were not effective in reducing body compositions, but as a safe supplement, it may help weight loss in overweight or obese people.

• Journal of Periodontal and Implant Science
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• v.46 no.1
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• pp.46-56
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• 2016

Purpose: We evaluated the efficacy of a mouthwash containing potassium nitrate ($KNO_3$) as its main component, along with sodium fluoride (NaF) and cetylpyridinium chloride (CPC). The primary endpoint was the relief of dentin hypersensitivity (DH) against the cold stimuli. The effects on other DH tests and periodontal inflammation were also evaluated. Methods: We used a single-center, double-blind, placebo-controlled, randomized design. A total of 82 patients with DH (40 in the test group, 42 placebo controls) were analyzed using visual analog scales (VASs) for a cold test, a tactile test, a compressive air test, and self-reported pain during daily activities, as well as clinical parameters including plaque index, gingival index, modified sulcular bleeding index (mSBI), gingival recession, and probing depth, which were collected at baseline and after four and six weeks of mouthwash use. Results: VAS scores for cold sensations, tactile sensations, the compressive air test, and self-reported pain significantly decreased from baseline during the six weeks in both groups (P<0.01), and no significant differences between the groups were found. In male patients (10 in the test group and 7 in the control group), both groups showed significant reductions in VAS scores for the cold test over the six weeks, and greater reductions were found in the test group than in the control group between four and six weeks (P=0.01) and between baseline and six weeks (P<0.01). In addition, the mSBI in the test group significantly decreased from baseline during the six weeks (P<0.01), and the changes at four and six weeks from baseline were significantly greater in the test group compared to the control group (P=0.03 and P=0.02, respectively). Conclusions: A mouthwash containing a mixture of $KNO_3$, NaF, and CPC reduced DH and gingival inflammation, however, the efficacy was comparable to the control group.

• The Korean Journal of Pain
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• v.18 no.1
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• pp.43-47
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• 2005

Background: The optimal management of pain using magnetic irradiation modalities continues to attract considerable debate. Therefore, we conducted a randomized, double-blind, placebo-controlled clinical trial to determine the effectiveness of pulsed electromagnetic therapy for the treatment of chronic lower back pain. Methods: Fifteen-minute sessions of active (n = 20) or placebo (n = 20) electromagnetic therapy were repeated 3 times a week for 3 weeks. Patients were assessed using the 11-point numerical rating scale and the revised Oswestry disability scores for up to 4 weeks after therapy. Results: The active magnetic group showed significantly more pain reduction than the placebo group immediately after therapy and one and four weeks after therapy (P < 0.05). At 4 weeks after therapy percentage changes in NRS from baseline were $22{\pm}24%$ and $38{\pm}11%$ in the placebo and magnetic groups, respectively. The revised Oswestry disability percentage in the active magnetic group was also significantly improved (P < 0.05). Conclusions: Pulsed electromagnetic therapy provided pain relief and ameliorated disability in patients with chronic lower back pain. According to our results, pulsed electromagnetic therapy should be considered an important potential therapeutic tool for the conservative therapy of chronic lower back pain.

• 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.