• Journal of Ginseng Research
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• v.44 no.5
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• pp.697-703
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• 2020

Background: GS-3K8 and GINST, both of which are modified ginseng extracts, have never been examined in terms of their effectiveness for the prevention of acute respiratory illness (ARI) in humans. We conducted a pilot study to assess the feasibility of performing a large-scale, randomized, controlled trial. Methods: This study was a randomized, double-blind, placebo-controlled, pilot study at a single center from October 2014 to March 2015. The 45 healthy applicants were randomly divided into the GS-3K8 (n = 15), GINST (n = 15), and placebo groups (n = 15). The study drug was administered as a capsule (500 mg/cap and 3000 mg/day). GS-3K8 contained 6.31 mg/g of Rg1, 15.05 mg/g of Re, 30.84 mg/g of Rb1, 15.02 mg/g of Rc, 12.44 mg/g of Rb2, 6.97 mg/g of Rd, 1.59 mg/g of Rg3, 3.25 mg/g of Rk1, and 4.84 mg/g of Rg5. GINST contained 7.54 mg/g of Rg1, 1.87 mg/g of Re, 5.42 mg/g of Rb1, 0.29 mg/g of Rc, 0.36 mg/g of Rb2, 0.70 mg/g of Rd, and 6.3 mg/g of compound K. The feasibility criteria were the rates of recruitment, drug compliance, and successful follow-up. The primary clinical outcome measure was the incidence of ARI. The secondary clinical outcome measures were the duration of symptoms. Results: The rate of recruitment was 11.3 participants per week. The overall rate of completed follow-up was 97.8%. The mean compliance rate was 91.64 ± 9.80%, 95.28 ± 5.75%, and 89.70 ± 8.99% in the GS-3K8, GINST, and placebo groups, respectively. The incidence of ARI was 64.3% (9/14; 95% confidence interval [CI], 31.4-91.1%), 26.7% (4/15; 95% CI, 4.3-49.0%), and 80.0% (12/15; 95% CI, 54.8-93.0%) in the GS-3K8, GINST, and placebo groups, respectively. The average days of symptoms were 3.89 ± 4.65, 9.25 ± 7.63, and 12.25 ± 12.69 in the GS-3K8, GINST, and placebo groups, respectively. Conclusion: The results support the feasibility of a full-scale trial. GS-3K8 and GINST appear to have a positive tendency toward preventing the development of ARI and reducing the symptom duration. A randomized controlled trial is needed to confirm these findings.

• Journal of Pharmacopuncture
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• v.25 no.3
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• pp.233-241
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• 2022

Objectives: Asthma is a chronic disease, and the demand for herbal medicines in this field has increased in recent years. The new findings highlight the role of the gut-lung axis in the pathophysiology of asthma. Hence, this study will evaluate the safety and efficacy of Glasthma syrup, an herbal formula based on Persian medicine, in improving asthma and regulating intestinal permeability. The formula consists of five herbal ingredients that have anti-inflammatory effects on the respiratory tract, also known as gut tonics. Methods: The study will be conducted as a placebo-controlled, triple-blind, randomized trial. It will consist of a 4-week intervention followed by a 4-week follow-up period. The target sample size is 20 patients with moderate asthma aged 18 to 60 years. Eligible participants will be randomly assigned to either the experimental group or the control group in equal numbers. Patients in the experimental group will take Glasthma syrup (7.5 mL, twice a day), while patients in the control group will take a matching placebo. Both groups will receive a 4-week combination of a long-acting beta2 agonist and a leukotriene modulator as standard of care. Inhaled corticosteroids can be used as rescue medication as needed. Results: The primary outcomes are asthma symptom scale, lung function, and intestinal permeability. Secondary outcomes include quality of life, symptom recurrence rates, and blood tests. A safety assessment will also be conducted during the trial. Conclusion: In this trial, the effects of Glasthma syrup in patients with moderate asthma will be examined. The study will also assess the effects of the formulation on the gut-lung axis by simultaneously monitoring the gut permeability index, asthma symptoms, and lung function.

• Journal of Food Hygiene and Safety
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• v.37 no.3
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• pp.198-205
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• 2022

Hepatic diseases are divided into two types: alcoholic and non-alcoholic. Non-alcoholic liver injury finally induces fatty liver and damages liver function. Many studies have demonstrated that Ecklonia stolonifera has antioxidative, anti-inflammatory, and hepatoprotective activities. We conducted a 12-week double-blind, placebo-controlled, randomized trial to examine the efficacy of E. stolonifera extracts (ESE) on biochemical markers of hepatic function. Sixty-five subjects with mild or moderate liver injuries were randomly allocated to receive either 420 mg/d of ESE or a placebo for 12 weeks. Fifty-five participants completed the trial. No significant adverse events were observed among the subjects during the study. The primary end points were changes in plasma levels of aspartate transaminase (AST), alanine transaminase (ALT), and γ-glutamyltransferase (γ-GT). The secondary end points were changes in lipid profile levels, including total cholesterol (TC), triglyceride (TG), high-density lipoprotein cholesterol (HDL), and low-density lipoprotein cholesterol (LDL). Compared with the baseline, AST and ALT levels decreased significantly in the ESE group compared to those in the placebo group (P<0.001). In addition, γ-GT levels in the ESE group were significantly lower than those in the placebo group (P=0.016). There were no differences in the TC, TG, HDL, and LDL levels between groups. In conclusion, ESE consumption for 12 weeks improved liver parameters in subjects with liver injury. Regular consumption of ESE could maintain liver health in individuals at risk of hepatic damage.

• Tuberculosis and Respiratory Diseases
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• v.46 no.2
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• pp.251-259
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• 1999

Background: Even though the necessity for premedication has been questioned, some combinations of antisialogogues, sedatives and analgesics are usually employed by most bronchoscopists. The goal of this study was to determine whether fiberoptic bronchoscopy(FOB) could be performed safely and effectively without premedication while using a standardized topical anesthetic. Method: Eighty outpatients were randomized in a double-blind manner into group I(n=20) with 1 ml normal saline, group II(n=20) with 0.5mg of atropine, group III(n=20) with 0.5mg of atropine plus 5mg of midazolam, and group IV(n=20) with 0.5mg of atropine plus 50mg of meperidine, given intramuscularly 30 minutes before FOB as premedication Topical anesthetics administered were same in each group. Each patient was given 5ml(200mg) of 4% nebulized lidocaine and additional intratracheobronchial 2% lidocaine. Oxygen saturation, pulse rate and electrocardiogram were monitored and recorded before, during, just after and 2 minutes after FOB. Immediately after FOB, the bronchoscopists answered four questions such as ease of procedure, extent of coughing, extent of secretion, and overall impression. Before leaving bronchoscopy suite, patients completed similar questions on discomfort during procedure, and willingness to return for a repeat procedure. Results: Age, gender, baseline pulmonary function, dose of 2% lidocaine used for topical anesthesia, and duration of FOB were not significantly different. There was no statistical difference among group I to IV with regard to extent of coughing answered by bronchoscopist. But extent of secretion was significantly different between group I without atropine and group II-IV with atropine. And there was also significant difference in ease of procedure and overall impression among groups. There was no statistical difference in patient's willingness and level of discomfort among the groups. Thirteen patients(16%) showed hypoxemia(arterial oxygen saturation: <90%), and 3 patients(4%) showed significant tachyarrhythmia(heart rate: > l60/min), but the rate of complication was not statistically different among the groups. Conclusion: These results suggest that the value of premedication is questionable for outpatient FOB, although it may be necessary in excessively anxious patient.

• Journal of Oriental Neuropsychiatry
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• v.18 no.1
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• pp.79-94
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• 2007

Objective : The Purpose of this research is to examine the effect of Sa-am acupuncture treatment(Sim-seungkyuk) for major symptoms of Hwa-byung. Method : In this randomized, single blind, placebo-controlled study, we compared active acupuncture with sham acupuncture in the treatment for major symptoms of Hwa-byung. likert scale(5 score) for major symptom of Hwa-byung was measured as the 1st evaluative instrument, and STAXI-K, STAI-K, BDI-K and HRV were also measured as the 2nd evaluative instrument at the before treatment and after treatment. Results : 26 volunteers participated in this study by dividing two groups, each 13 persons in trial group and control group at random. In comparison of likert scale for major symptoms, after treatment the total score of likert scale for major symptoms decreased significantly in both group than before treatment. And after treatment, the total score of trial group decreased less than those of control group in comparison between two groups. especially after 2 weeks from all treatment, there was significant difference between two groups. Conclusion : We considered that Shim-seungkyuk of Sa-am acupuncture treatment will be not recommended to treatment of Hwa-byung because this study could not prove effect of Shim-seungkyuk treatment for Hwa-hyung in spite of preliminary study. This study will be used to provide a fundamental data for development of clinical research as preliminary study of Hwa-byung.

• Preventive Nutrition and Food Science
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• v.6 no.1
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• pp.51-56
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• 2001

This study was carried out to evaluate whether antioxidant nutrient suppplementation with $\alpha$-tocopherol, vitamin C, $\beta$-carotene, and selenium reduces the lipid peroxide levels and increases the antioxidative enzyme activities in patients with coronary hart disease. Eighty nine patients participated in a randomized, double-blind, placebo-controlled trial. The antioxidant group (45 patients) was given daily doses of $\alpha$-tocopherol (400 IU), vitamin C (50 mg), $\beta$-carotene (15 mg), and selenium (50 $\mu\textrm{g}$) and forty four patients received a placebo. Thirty eight subjects (84.4%) of the antioxidant group and thirty nine subjects (88.6%) of the placebo group completed the three-month supplementation. Serum levels of tocopherol, vitamin C and $\beta$-carotene significantly increased in the antioxidant group compared with the baseline (p<0.05). Thiobarbituric acid-reactive substances(TBARS) decreased significantly (0.6 nmol MDA/mL) in the antioxidant group compared with that (0.09 nmol MDA/mL) in the placebo group (p=0.03). However, antioxidant supplementation did not affect the level of oxidized-LDL measured as autoantibodies against oxidized-LDL. The superoxide dimutase activity in red blood cells increased in the antioxidant group compared with the baseline (p<0.05). However, glutathione peroxidase activities did not change after supplementation in both groups, and catalase activity significantly decreased in the placebo group (p<0.05). These results suggest that antioxidant supplementation for 3 months with $\alpha$-tocopherol, vitamin C, $\beta$-carotene and selenium in patients with coronary heat disease may be partially protective against oxidative stress.

• Journal of Acupuncture Research
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• v.24 no.1
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• pp.1-12
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• 2007

Objectives : Functional dyspepsia is a prevalent disease. It impedes subjective quality of life. The purpose of this research is to examine the effect of acupuncture treatment for functional dyspepsia. Methods : In this randomized, single blind, placebo-controlled study, we compared active acupuncture with sham acupuncture for the treatment of functional dyspepsia. Volunteers who satisfied the requirements were enrolled in study. Severity of dyspepsia was measured by Nepean Dyspepsia Index(NDI) and Functional Dyspepsia Quality fo Life(FD-QOL) before and after treatments. Results : 68 subjects finished study. There were not difference between two groups on age, sex, weight, height, severity of dyspepsia, subtype, Byeonjeung, surmise of treatment. After treatment total key symptoms score, improve rate of key symptoms were decreased than before treatment in active acupuncture group, but there were no statistical significance compared with sham acupuncture group. After treatment "pressure in upper abdomen" and " cramps in upper abdomen" were more decreased in active acupuncture group compared with sham acupuncture group(p=0.001, p=0.014). After treatment total symptom score and QOL of NDI were decreased than before treatment in active acupuncture group, but there were no statistical significance compared with sham acupuncture group. After treatment eating status of FD-QOL in active acupuncture group was significantly increased than sham acupuncture group(p=0.008). After treatment liveliness status of FD-QOL and total score of FDQOL in active acupuncture group was increased than sham acupuncture group though statistically insignificant(p=0.095, p=0.077). Conclusion : Acupuncture treatment is effective to improve the symptoms and quality of life in patients with functional dyspepsia.

• Journal of Korean Medicine for Obesity Research
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• v.4 no.1
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• pp.45-54
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• 2004

Objective: To evaluate the effect of Ephedra Sinica and Evodia Rutaecarpa on resting metabolic rate(RMR), weight and body composition in obese women during low-calorie diet. Methods: We recruited 90 healthy premenopausal women$(body\;mass\;index{\geq}25kg/m^2)$ and randomly assigned to three groups(ephedra group, evodia group and placebo group). Subjects were administered Ephedra Sinica(6g twice a day) or Evodia Rutaecarpa(6g twice a day) or placebo in a double-blind fashion and participated in low-calorie diet for 8 weeks. Resting metabolic rate and body composition were measured at baseline, 4 and 8 weeks. Results: RMR change for 4 weeks was significantly higher in the ephedra group compared with the placebo group(p<.05). But the change for 8 weeks was not significant and the Evodia group showed no significant RMR change. Weight and percent body fat changes for 4 weeks and 8 weeks were significantly higher than the placebo group in the ephedra group(p<.05), but the Evodia group didn't show significant level. Conclusions: This study supports and emphasizes the benefits of herbal medicine in maintaining or increasing RMR during low-calorie diet. Especially Ephedra treatment was effective on significant maintainment of RMR, loss of weight and percent body fat(P<.05).

• Korean Journal of Oriental Medicine
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• v.15 no.3
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• pp.83-91
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• 2009

$\beta$-glucan is a fiber-type complex sugar (polysaccharide) derived from the cell wall of baker's yeast, oat and barley fiber, and many medicinal mushrooms, such as maitake. The primary uses of $\beta$-glucan are to enhance the immune system, to lower blood cholesterol levels and to treat tumor. $\beta$-glucan has no systemic toxicity in mice, therefore it needed clinical trail to prove efficacy and safety for human. The subjects total 56 healty volunteers were divided into two groups including taken $\beta$-glucan tablet group and placebo group. Subjects were taken two tablets per oral for 4 weeks. They had agreed to take part in this experiment, and didn't take any other clinical trail products. After 4 weeks blood of subjects were checked. The check list are TNF-$\alpha$, INF-$\gamma$, IL-2, IL-4, total WBC, differential WBC, RBC, hemoglobin, platelet, MCV, MCH, MCHC, HCT, Na, K, Ca, Cl, AST, ALT, ALP, $\gamma$-GTP, total protein, triglyceride, total cholesterol, total bilirubin, albumin, uric acid, creatinine, BUN, pH, protein, glucose, ketone body, blood, bilirubin. We evaluated efficacy by cytokines that compare before and after taking. Collected data were analyzed as two sample t-test, chi-square test and ANOVA using SAS V.9.1.This study results are that in TNF-$\alpha$ of $1^{st}$ efficacy measurement item, all of two groups figure were increased significantly compare to before figure. In IL4 of $2^{nd}$ efficacy measurement item, experimental group figure were decreased significantly but placebo group figure were increased. The conclusions show that based on the above results, $\beta$-glucan has favorable effect to enhance immune system, especially IL4 results showed that it has effect to improve the allergic immune system.

• Osteoporosis and Sarcopenia
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• v.2 no.4
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• pp.228-237
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• 2016

Objective: There has been no prospective study that examined intramuscular injection of high-dose vitamin D in Korean adults. The aim of this study was to assess the efficacy and safety of high-dose vitamin $D_3$ after intramuscular injection in Korean adults with vitamin D deficiency. Method: This study was a 24-week, prospective, multicenter, randomized, double-blind, placebo-controlled trial. A total of 84 subjects ${\geq}19$ and <65 years of age were randomly allocated to either the vitamin $D_3$ or placebo group in a 2:1 ratio. After randomization, a single injection of plain vitamin $D_3$ 200,000 IU or placebo was intramuscularly administered. If serum 25-hydroxyvitamin D (25[OH]D) concentrations were <30 ng/mLon week 12 or thereafter, a repeat injection was administered. Results: After a single intramuscular injection of vitamin $D_3$ to adults with vitamin D deficiency, the proportion of subjects with serum 25(OH)D concentrations ${\geq}30ng/mL$ within 12 weeks was 46.4% in the vitamin $D_3$ group and 3.6% in the placebo group (p<0.0001). The proportion of subjects with serum 25(OH)D concentrations ${\geq}30ng/mL$ within 24 weeks was 73.2% in the vitamin $D_3$ group and 3.6% in the placebo group (p<0.0001). Mean change in serum 25(OH)D concentrations at weeks 12 and 24 after vitamin $D_3$ injection was $12.8{\pm}8.1$ and $21.5{\pm}8.1ng/mL$, respectively, in the vitamin $D_3$ group, with no significant changes in the placebo group. Serum parathyroid hormone concentrations showed a significant decrease in the vitamin $D_3$ group but no change in the placebo group. Conclusion: Intramuscular injection of vitamin $D_3$ 200,000 IU was superior to placebo in terms of its impact on serum 25(OH)D concentrations, and is considered to be safe and effective in Korean adults with vitamin D deficiency.