• Journal of Acupuncture Research
• /
• v.27 no.4
• /
• pp.195-202
• /
• 2010

Objectives : This study was performed to report adverse events in Ojeok-san extract powders RCT. Methods : 180 patients with LBP were randomized into groups for a double blind, placebo-controlled clinical study. They received Ojeok-san simple Extract, Ojeok-san complex Extract or placebo in powders, orally dissolved 3times a day for 4weeks. During 4weeks, we researched the symptoms and duration of adverse events and Digest ability, Milk hypersensitivity, Starch hypersensitivity, Caramel hypersensitivity, West-med hypersensitivity, Herb-med hypersensitivity in patients who had adverse events. Results : 52patients(28.9%) had adverse events and of them 44patients(28.9%) had lost adverse events naturally. But 5patients(2.8%) were withdrawn from the research because of the adverse events. Most of the symptoms of adverse event was Gastrointestinal symptom(88.3%) and adverse events frequency was not different from Ojeok-san simple Extract, Ojeok-san complex Extract and placebo. Conclusions : Ojeok-san extract powders had adverse events no different from the placebo, which shows that it is a safe drug.

• Pediatric Gastroenterology, Hepatology & Nutrition
• /
• v.23 no.3
• /
• pp.251-258
• /
• 2020

Purpose: Proton-pump inhibitors (PPIs) are frequently used to treat gastroesophageal reflux disease (GERD) in children, but recent evidence suggests a potential association between PPI treatment and some types of infections. The aim of this study was to assess the effectiveness of Lactobacillus rhamnosus GG (LGG) for the prevention of gastrointestinal and respiratory tract infections in children with GERD treated with PPI (omeprazol). Methods: Children younger than 5 years with GERD were assigned by a computer-generated list to receive LGG (10⁹ colony-forming units) or placebo, twice daily, concomitantly with PPI treatment for 4-6 weeks; they were followed up for 12 weeks after therapy. The primary outcome measures were the percentage of children with a minimum of one episode of respiratory tract infection and the percentage of children with a minimum of one episode of gastrointestinal infection during the study. Results: Of 61 randomized children, 59 patients (LGG n=30; placebo n=29, mean age 11.3 months) were analyzed. There was no significant difference found between the LGG and placebo groups, either for the proportion of children with at least one respiratory tract infection (22/30 vs. 25/29, respectively; relative risk [RR] 0.85, 95% confidence interval [CI] 0.66-1.10) or for the proportion of children with at least one gastrointestinal infection (9/30 vs. 9/29, respectively; RR 0.97, 95% CI 0.45-2.09). Conclusion: LGG was not effective in the prevention of infectious complications in children with GERD receiving PPI. Caution is needed in interpreting these results, as the study was terminated early due to slow subject recruitment.

• Journal of Ginseng Research
• /
• v.34 no.3
• /
• pp.237-245
• /
• 2010

The purpose of this study was to evaluate the effect of Korean red ginseng (KRG) on ocular blood flow in patients with glaucoma. In a prospective, randomized, placebo-controlled, double-masked crossover trial, 36 patients with open-angle glaucoma were consecutively recruited. Subjects were randomly assigned into two groups. Group A received 1.5 g KRG, administered orally three times daily for 12 weeks, followed by a wash-out period of 8 weeks and 12 weeks of placebo treatment (identical capsules filled with 1.5 g corn starch). Group B underwent the same regimen, but took the placebo first and then KRG. Blood pressure, heart rate, and intraocular pressure were measured at baseline and at the end of each phase of the study. Visual field examination and ocular blood flow measurements by the Heidelberg Retina Flowmeter were performed at baseline and at the end of each phase of the study. Changes in blood pressure, heart rate, intraocular pressure, visual field indices, and retinal peripapillary blood flow were evaluated. Blood pressure, heart rate, intraocular pressure, and visual field indices did not change after placebo or KRG treatment. After KRG treatment, retinal peripapillary blood flow in the temporal peripapillary region significantly improved (p=0.005). No significant changes were found in retinal peripapillary blood flow in either the rim region or the nasal peripapillary region (p=0.051 and 0.278, respectively). KRG ingestion appears to improve retinal peripapillary blood flow in patients with open-angle glaucoma. These results imply that KRG ingestion might be helpful for glaucoma management.

• Nutrition Research and Practice
• /
• v.15 no.3
• /
• pp.309-318
• /
• 2021

BACKGROUD/OBJECTIVES: Data regarding the effects of poly-γ-glutamic acid (γ-PGA) on sleep status are limited. This study aimed to test whether γ-PGA and vitamin B₆ (VitB6) supplements improve sleep duration and quality. SUBJECTS/METHODS: A factorial randomized, double-blinded, placebo-controlled crossover study included 47 adults (25 men and 22 women) who were free of chronic disease. Stratified randomized allocation considered age and gender for three interventions, group A (supplementation with γ-PGA 600 mg; n = 16), group B (supplementation with VitB6 100 mg; n = 14), and group C (dual supplementation of both γ-PGA 600 mg and VitB6 100 mg; n = 17). Participants underwent a 1-mon intervention period, followed by a 1-mon washout period, and then a second 1-mon intervention period. Differences (mean ± SD) in nighttime sleep status before and after supplementation were compared between the placebo and intervention groups using nonparametric tests. RESULTS: Significant changes in sleep duration (0.27 ± 0.98 h, P < 0.05) and the Pittsburgh Sleep Quality Index global score (-0.52 ± 1.58, P < 0.05) indicating improved sleep status were observed in the intervention compared with the placebo of group C while no significant changes were observed in groups A and B. No statistical significance was detected between the intervention and the placebo; however, there was a greater increase in the group C intervention (4.59 ± 38.5 ng/mL) in serum serotonin concentrations than the groups A and B interventions. No side effects were observed. CONCLUSIONS: On the basis of these findings, the dual supplementation of γ-PGA and VitB6 may be effective as functional food components to improve nighttime sleep status.

• Journal of Korean Medicine Rehabilitation
• /
• v.30 no.1
• /
• pp.105-113
• /
• 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
• /
• v.46 no.1
• /
• pp.46-56
• /
• 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.

• Journal of Korean Medicine for Obesity Research
• /
• v.17 no.2
• /
• pp.87-95
• /
• 2017

Objectives: This study was conducted to evaluate efficacy and safety of Punica granatum L. Actinidia chinensis Planch. mixed extract on body fat. Methods: Thirty women were recruited ($25kg/m^2{\leq}body$ mass index [BMI]${\leq}29.9kg/m^2$) ($19yr{\leq}age{\leq}38yr$) and randomized to receive Punica granatum L. Actinidia chinensis Planch. mixed extract or placebo for 8 weeks. During the test, they visited four times including screening. Body fat mass, body fat rate, anthropometric dimensions at waist and hip, waist-hip ratio, total cholesterol, triglyceride, low density lipoprotein-cholesterol (LDL-C), and high density lipoprotein-cholesterol (HDL-C) were measured at screening and 8 weeks after screening. Adverse reaction were also checked each visit. Results: There were no significant differences in all index. But when divide experimental group by BMI index, age, and compliance, less than BMI $27kg/m^2$ group decreased body weight, body fat mass and more than BMI $27kg/m^2$ group also decreased body weight, body fat mass and waist circumference. Less than age 30 years group showed decline of waist circumference, fat free rate and T-cholesterol and more than age 30 years group showed decline of fat free mass. Group with compliance more than 95% was decreased BMI, fat free mass, and hip circumference. Conclusions: There was no significant efficacy as compared with placebo group, but as divide experimental group according to BMI index, age, compliance, mixed extract might be effective to reduce obesity index.

• Food Science and Biotechnology
• /
• v.17 no.6
• /
• pp.1261-1264
• /
• 2008

In the present study, a randomized, double-blind, placebo-controlled trial to determine the effect of conjugated linoleic acid (CLA) supplementation (50:50 ratio of cis-9, trans-11 and trans-10, cis-12 isomers) for 8 weeks on body composition and biochemical parameters in healthy overweight/obese (body mass index, BMI${\geq}23\;kg/m^2$) Korean subjects was performed, Thirty participants (3 males and 27 females) were randomized to receive placebo (2.4 g olive oil/day) or 2.4g/day CLA (mixture containing 36.9% of cis-9, trans-11 and 37.9% of trans-10, cis-12). Eight weeks of CLA supplementation significantly decreased body weight by -0.75kg, BMI by $-0.27\;kg/m^2$, and hip circumference by -1.11 cm. The reduction of body weight was ascribed to the reduction of body fat mass (-0.59 kg) and lean body mass (-0.18 kg), although these changes were not significant. No significant differences in serum lipid profiles, liver function enzyme activities, and protein concentration were observed in either the CLA or placebo groups. These results indicate that short tenn supplementation (8 weeks) with CLA (2.4 g/day) may decrease body weight in Korean overweight/obese subjects.

• Journal of the Korean Society of Physical Medicine
• /
• v.18 no.2
• /
• pp.1-11
• /
• 2023

PURPOSE: This study examined the immediate effects of applying ankle eversion taping using kinesiology tape in chronic stroke patients-design: a randomized cross-over trial. METHODS: Seventeen stroke patients underwent three interventions in random order. The subjects were initially assigned randomly to an ankle eversion taping, placebo taping, or no taping for each intervention. Ankle eversion taping was used for mechanical correction and was involved in ankle dorsiflexion and eversion. The tape was stretched by 30-40%. Placebo tapping was applied in the same form as eversion tapping but was not stretched. The balance ability was assessed using the Y-balance test. The gait ability was assessed by maximum foot pressure and time of stance phase, and gait speed was assessed using a 10 m walk test (10MWT). All measurements were performed immediately after the intervention. RESULTS: The results showed that the dynamic balance and stance phase time in chronic stroke patients was improved after ankle eversion taping. The ankle eversion taping conditions increased significantly (p < .05) compared to the placebo and no taping conditions. CONCLUSION: The application of ankle eversion taping that uses kinesiology tape instantly increased the gait ability of chronic stroke patients. On the other hand, more research will be needed to identify the long-term effects of ankle eversion taping.

• The Journal of Internal Korean Medicine
• /
• v.27 no.1
• /
• pp.188-196
• /
• 2006

Background: Ma-huang (Ephedra sinica) has been widely used to treat respiratory disease in oriental medicine for over a hundred years. Ma-huang preparations contain approximately 1.25% ephedrine alkaloids. Recently, the ephedra alkaloids have received much press lately due to adverse effects in those using whole extracts as 'dietary supplements' for weight loss or athletic performance enhancement, and these reports are troubling given the increasing use of Ma-huang by the general public. The purpose of this report is to determine the proper dosage to minimize adverse effects and maximize the potential curative value. Objectives : The object of this study was to find an effective yet low risk dosage of Ma-huang. Methods : The study was designed as a double-blind randomized placebo-controlled trial. The subjects of this study were 26 adults between 20 to 40 of age who agreed to participate in this study. They were allocated through randomization into three groups. Each group took three opaque capsules three times a day. A group (N=9) took one Ma-huang capsule and two placebo capsules, B group (N=8) took two Ma-huang capsules and one placebo capsule, C group (N=9) took three Ma-huang capsules. The total trial periods was two days. To compare the adverse effects of Ma-huang according to dosage, blood pressure and pulse were checked, and other adverse effects were assessed using a morning questionnaire, patient's global assessment scale and Wong-Baker faces pain rating. Results : The following result were obtained: 1. After taking 18 g of Ma-huang per day, pulse rate had a significant increase. 2. After taking more than 6 g of Ma-huang per day, palpitation would be increased significantly. 3. After taking more than 18 g of Ma-huang per day, tiredness would be increased significantly. Conclusion: According to the results, 12 g of Ma-huang per day will minimize adverse effects and maximize the potential curative value.