• 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 Korean Medicine Rehabilitation
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• v.29 no.1
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• pp.63-73
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• 2019

Objectives The purpose of this study is to evaluate the safety of Ojeok-san extract powder and soft extract in healthy male volunteers. Methods Randomized controlled, cross over study was carried out in healthy male volunteers. Total 27 of 31 subjects meeting the inclusion criteria were enrolled and three subjects for waiting were included. To each group 12 subjects were randomly allocated by random number table. Group A took the extract powder in the first period and then took the soft extract in the second period. Group B took the medicine in the opposite order. Trial was conducted through two times of hospitalizations and all subjects had a seven-days of wash out period. Vital sign and laboratory test were checked before and after the medication. The mean difference of safety evaluation variables were analyzed by paired t-test (p<0.001) or wilcoxon signed rank test (p<0.05). The mean difference between two groups were analyzed by independent t-test (p<0.05) or Mann whitney test (p<0.05). Results As a result of all data related to vital sign and laboratory test in both group, There were no significant differences associated with the clinical trial drug between before and after the medication. And there was no adverse event associated with the clinical trial drug. Conclusions Both Ojeok-san extract powder and soft extract were found to be safe for healthy male volunteers.

• Journal of Acupuncture Research
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• v.39 no.3
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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.

• Journal of the Korean Association of Oral and Maxillofacial Surgeons
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• v.48 no.6
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• pp.356-362
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• 2022

Objectives: A single-blinded randomized controlled trial was designed to compare and evaluate the effectiveness of the periotome and piezotome as aids for atraumatic extraction and its sequalae. Materials and Methods: The study sample comprised 48 teeth, equally allotted to the piezotome or periotome groups by random allocation, in participants aged 19-62 years. All samples in both groups had either complete tooth structure or intact roots without crowns and had mobility ≤grade II. Clinical parameters of operative duration, presence or absence of gingival laceration, reported operative and postoperative pain, and intake of analgesics following extraction were recorded. IBM SPSS software package version 22 was used for data entry and analysis. Results: The mean operation time was significantly (P≤0.05) longer in the piezotome group than in the periotome group. However, fewer gingival lacerations were observed with use of a piezotome than with a periotome, although no significant difference was observed. The piezotome group reported significantly (P≤0.05) higher visual analog scale (VAS) pain scores during the procedure and non-significantly higher scores thereafter until the third postoperative day. In the piezotome group, the dosage of analgesic was higher, although the periotome group had a higher percentage of participants who used analgesics postoperatively; however, these differences were not statistically significant. Conclusion: The present clinical trial favors the use of periotome over piezotome for atraumatic extraction due to shorter operating time, lower postoperative VAS pain scores, and lower dosage of analgesics despite the superior ability of the piezotome to prevent gingival laceration.

• The Journal of Korean Obstetrics and Gynecology
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• v.33 no.3
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• pp.149-174
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• 2020

Objectives: This study was aimed to figure out the effect of Onkyung-tang (OKT) on cold hypersensitivity on feet in female patients. Methods: This study was designed to implement multi-center randomized clinical trial in three korean medical hospitals. The female patients who were enrolled in this study were 112 women who suffered from cold hypersensitivity on feet. They were randomly allocated into OKT group or control group in 1:1 ratio. The primary outcome was change in score of visual analogue scale of hypersensitivity on feet, and the secondary outcomes were thermometer of LU4, PC8, ST32, LR3, visual analogue scale of hypersensitivity on hands, result of cold stress test, and score of World Health Organization Quality of Life-BREF. Results: In both group, the VAS of hypersensitivity on feet and hands was decreased while taking the medicine, and the effect of decreasing the VAS continues for the 4 weeks after the end of medication (p<0.001, 0.003, 0.001). In OKT group, the body temperature difference in lower extremity (ST32-LR3) was steadily decreased at every visit and it was statistically significant(p=0.003, <0.001). On the other hand, in control group, the body temperature difference in lower extremity was decreased only while taking the medicine (p<0.001). Conclusions: OKT significantly reduced discomfort coldness on feet in patients, and the effect of treatment was maintained at least for four weeks after medication.

• The korean journal of orthodontics
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• v.50 no.6
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• pp.373-382
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• 2020

Objective: To compare computer-aided design and computer-aided manufacturing (CAD/CAM) customized nitinol retainers with standard stainless-steel fixed retainers over a 12-month study period. Methods: This randomized controlled trial (RCT) was conducted on 62 patients randomly allocated to a control group that received stainless-steel retainers or a test group that received customized CAD/CAM nickel-titanium retainers. Four time points were defined: retainer placement (T0) and 1-month (T1), 6-month (T2), and 12-month (T3) follow-up appointments. At each time point, Little's irregularity index (LII) (primary endpoint) and dental stability measurements such as intercanine width were recorded in addition to assessment of periodontal parameters. Radiological measurements such as the incisor mandibular plane angle (IMPA) were recorded at T0 and T3. Failure events (wire integrity or debonding) were assessed at each time point. Results: From T0 to T3, LII and other dental measurements showed no significant differences between the two groups. The data for periodontal parameters remained stable over the study period, except for the gingival index, which was slightly, but significantly, higher in the test group at T3 (p = 0.039). The IMPA angle showed no intergroup difference. The two groups showed no significant difference in debonding events. Conclusions: This RCT conducted over a 12-month period demonstrated no significant difference between customized CAD/CAM nickel-titanium lingual retainers and standard stainless-steel lingual retainers in terms of dental anterior stability and retainer survival. Both retainers eventually appeared to be equally effective in maintaining periodontal health.

• 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.

• 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 Korean Medicine for Obesity Research
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• v.17 no.2
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• pp.87-95
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• 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.

• Clinical Nutrition Research
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• v.13 no.1
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• pp.74-87
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• 2024

Since the effects of cinnamon supplementation on lipid profiles are still controversial, this study conducted a meta-analysis of randomized controlled trials to assess the effect of cinnamon supplementation on lipid profiles. The study was designed and conducted according to the guidelines of the 2020 preferred reporting items for systematic reviews and meta-analysis (PRISMA) statements. A systematic and comprehensive search was performed in several databases from inception up to 11 November 2023. The meta-analysis on the impact of Cinnamon on lipid profiles indicates a non-significant overall effect on low-density lipoprotein (weighted mean differences [WMD], -2.48; 95% confidence interval [CI], -9.70, 4.72). However, significant reductions are seen with doses < 500 mg/day (-10.26), and non-significant increases with doses ≥ 500 mg/day (1.18). The overall effect on high-density lipoprotein is non-significant (WMD, 3.97; 95% CI, -7.877, 15.831), showing varying responses at different doses. Triglycerides exhibit a significant overall reduction (WMD, -6.88; 95% CI, -12.62, -1.15), particularly in the < 500 mg/day group. The overall effect on cholesterol is non-significant (WMD, -4.314; 95% CI, -15.011, 6.384), with diverse responses at different doses. High heterogeneity underlines the importance of standardized study designs and further exploration of dosage-specific effects. Findings from this study suggest that cinnamon supplements might be beneficial to modulate the blood lipid profile.