• 한방안이비인후피부과학회지
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• 제37권2호
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• pp.14-26
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• 2024

Objectives : The purpose of this study is to assess the feasibility of conducting a study on traditional Korean medicine treatments for periodontal diseases, specifically gingivitis and mild periodontitis. Methods : This study will employ a randomized, controlled, parallel-group design. Subjects with gingivitis and mild periodontitis will be recruited in one university hospital. In total, 45 subjects will be randomized into three arms (Acupuncture therapy group, herbal mouthwash group and usual care group), and will be followed up for 4 weeks. We will assess clinical variables such as, pocket depth, bleeding on probing, gingival index, plaque index, visual analog scale, uroqol-5 dimensions-5 levels to analyze changes in microbial flora before and after the intervention. Results : The protocol for this study was approved by the Institutional Review Board (IRB) of Dongguk University Ilsan Oriental Medicine Hospital, and registered with the Korean Clinical Trial Registry on March 29, 2024. Conclusions : This study is the first clinical research on periodontal diseases conducted in a Korean traditional medicine institution. The research aims to broaden the scope of traditional Korean medicine and is expected to serve as crucial data for future large-scale studies.

• 대한한방소아과학회지
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• 제37권3호
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• pp.121-132
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• 2023

Objectives We aimed to confirm whether Humulus japonicus Extract Powder can enhance child height growth significantly and safely compared with a placebo. Methods A total of 150 children between the 3rd and 25th percentiles in height and between the ages of 6 and 9 years will be recruited to participate in this randomized, double-blind, placebo-controlled clinical trial. The participants will be randomly assigned to the treatment or placebo group. Participants in the treatment group will take one pack per day (700 mg of Humulus japonicus Extract Powder) for 24 weeks. Participants in the placebo group will take one package of placebo per day (0 mg of Humulus japonicus Extract Powder) for 24 weeks. The primary outcome will be a change in height after 12 weeks, and the secondary outcomes will be the height after 24 weeks, growth rate, height standard deviation, growth hormone, insulin-like growth factor-1 (IGF-1), insulin-like growth factor binding protein-3 (IGFBP-3), bone alkaline phosphatase (BALP), and osteocalcin after 12 and 24 weeks. Results This protocol was approved by the Institutional Review Board (IRB) of the Korean Medicine Hospital of Busan University (IRB No. PNUKHIRB-2023-03-002). Research participants will be recruited from June 2023 to December 2023. Conclusions The results of this study provide clinical information regarding the effectiveness and safety of the Humulus japonicus Extract Powder in increasing child height.

• 대한한방부인과학회지
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• 제31권1호
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• pp.84-98
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• 2018

Objectives: The purpose of this pilot study was to examine the feasibility of recruiting women into a clinical trial designed to examine the effects of acupuncture and electroacupuncture in treating overactive bladder (OAB) in menopause women. We tried to determine if there was preliminary evidence to suggest that acupuncture may be effective in reducing OAB symptoms and improving disease-specific quality of life. We also tried to determine the appropriate treatment duration of OAB, with safety of performing acupuncture and electroacupuncture treatment. Methods: This study was a randomized clinical trial. 7 menopause women were randomly assigned to a electroacupuncture group (EA group) (n=4) or acupuncture group (AC group) (n=3) and received electroacupuncture or acupuncture treatment twice a week (16 sessions) in 8 weeks, and follow up assessment was performed after the end of treatment. Overactive Bladder Symptom Score (OABSS), 3-day bladder diary, and King's Health Questionnaire (KHQ) were performed 4 times (at baseline (visit 0), the middle of treatment (visit 8), after the end of treatment (visit 16), and at 4 weeks of follow-up (visit 17)) and analyzed. 2 subjects were dropped out, and finally 5 subjects completed the study. Statistical analysis was performed using SPSS 18.0 for window program. Results: There was an significant improvement in night-time frequency after the treatment (visit 17) in PP (Per-protocol) group analysis (p=0.042). In additional ITT (Inter-to-treat) group analysis, the OABSS (p=0.042) and night-time frequency (p=p=0.017) were improved significantly after the treatment (visit 17). But there was no significant difference of KHQ before and after the treatment. Also there was no significant difference between EA and AC group after the treatment (visit 16, 17). Conclusions: The results of this pilot study suggested that it was feasible to recruit subjects and perform the study procedures, after reconstructing several details of study protocol in performing further clinical trial.

• Journal of Periodontal and Implant Science
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• 제51권3호
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• pp.199-212
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• 2021

Purpose: This randomized clinical placebo-controlled trial was conducted to evaluate the effectiveness of Lactobacillus reuteri as a probiotic in guided pocket recolonization (GPR) for the treatment of chronic periodontitis (CP) adjunctive to scaling and root planing (SRP). Methods: Forty-eight CP patients were randomly assigned to 3 treatment groups: group 1 (SRP+placebo), group 2 (SRP+single application of probiotic), and group 3 (SRP+incremental application of probiotic). Clinical parameters were evaluated at baseline and at 8, 12, and 24 weeks, whereas biochemical parameters were measured at baseline and 12 weeks. Results: At 24 weeks, the probing pocket depth and clinical attachment level improved in all 3 groups from baseline with no significant intergroup differences; however, a statistically significant difference was observed in localized plaque and gingival scores between groups 1 and 3 (P<0.05). At 12 weeks, matrix metalloproteinase-8 (MMP-8), nitric oxide (NO), and gingipains-R (Rgps) levels improved in all 3 groups, with statistically significant differences between groups 1 and 3 for MMP-8 and NO (P<0.05), but no difference for Rgps levels. Conclusions: Within its limitations, the results of this study show that incremental 3-time application of L. reuteri as a probiotic led to improvements in clinical and biochemical parameters. This protocol can be a useful adjunct to SRP in the non-surgical management of CP.

• 대한한의진단학회지
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• 제19권2호
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• pp.91-100
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• 2015

Objectives The aim of this study is to develop a structured clinical protocol related with acquisition of radial pulse wave in the randomized, $2{\times}2$ cross-over design, and cold-heat intervention trial for a pilot and preliminary study. Methods The protocol was contrived based on wide ranging literature searches for cold-heat intervention experiments and radial pulse diagnoses. Results Sample size of 60 subjects was calculated based on an effect size derived from the previous study designed to detect the pre-post cold-heat differences in the radial pulse. Each subjects will be randomly assigned to the cold (first) to heat (last) group (n=30) or heat (first) to cold (last) group (n=30). All subjects will fill out a case report form and questionnaires related with pattern identification, dietary patterns, sleep quality, and physical activity will be surveyed and used as a secondary outcomes. Safety assessment will be reported at the final stage. Conclusions This protocol will provide an additional reference to future studies related with observation of radial pulse during any interventions and also expect to be used as a guideline for acquisition of reliable radial pulse wave data.

• Restorative Dentistry and Endodontics
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• 제49권2호
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• pp.15.1-15.11
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• 2024

Objectives: This study aimed to establish a single-session associative protocol for nonrestorative management of dentin hypersensitivity (DH). Materials and Methods: Twenty-four individuals with DH and a minimum sensitivity level of 4 on the visual analog scale (VAS) were selected. The study was conducted in a split-mouth design, with each participant (n = 20) having at least 1 affected tooth in all quadrants. The management protocols consisted of control group: universal adhesive, Neural Desensitizing Protocol group: 5% potassium nitrate, Mixed Desensitizing Protocol (PAM) group: 5% sodium fluoride and 5% potassium nitrate, Remineralizing Desensitizing Protocol (PDR) group: surface-partially reacted glass technology photopolymerizable varnish. Evaluations were performed immediately after application, at 1 week, 1 month, 2 months, and 12 months using the VAS sensitivity test. Results: The scores were subjected to statistical analysis using the Friedman test (p < 0.05), Durbin-Conover test (p < 0.05), and Wilcoxon test (p < 0.05). At the 12-month evaluation, all groups showed statistically significant differences compared to the initial assessment. For the evaluation after 12 months, there was a statistically significant difference between the PAM group, the control group, and the PDR group. Conclusions: It can be concluded that all groups were effective in controlling DH, but there were significant results in the control group and PDR group. The clinical relevance of this study is to demonstrate that the application of single-session desensitizing protocols can be effective in controlling DH for up to 12 months.

• Clinical Endoscopy
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• 제57권2호
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• pp.203-208
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• 2024

Background/Aims: Upper gastrointestinal bleeding (UGIB) is the most common GI condition requiring hospitalization. The present study aimed to evaluate the safety and feasibility of using the PillSense system (EnteraSense Ltd.), a novel diagnostic tool designed for the rapid in vivo detection of UGIB, in human volunteers. Methods: In the present study, 10 volunteers swallowed a PillSense capsule, followed by 2 servings of an autologous blood preparation. Participants were monitored for capsule passage, overall tolerability of the procedure, and adverse events. Results: The procedure was completed per the protocol established in the present study in 9/10 cases. In 9 of the subjects, after capsule ingestion, the device indicated the absence of blood with sensor output values of 1. After the ingestion of the first blood mixture, the sensor outputs of all devices increased to a range from 2.8 to 4, indicating that each sensor capsule detected blood. The sensor output remained within that range after the ingestion of the second mixture; however, in one case, the baseline capsule signal was positive, because of a preexisting condition. The passage of the capsule was verified in all patients, and no adverse events were reported. Conclusions: The first trial of the PillSense system in human subjects demonstrated the feasibility, safety, and tolerability of utilizing this product as a novel, noninvasive, and easy-to-use triage tool for the diagnosis of patients suspected of having UGIB.

• Journal of Acupuncture Research
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• 제23권1호
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• pp.165-177
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• 2006

Objectives : 1. Clinical trial for the efficacy evaluation of Korean acupuncture techniques in treating frozen shoulder. 2. Development of the standard clinical guidelines of the acupuncture treatment for the frozen shoulder. 3. Development of the new clinical protocol for the acupuncture treatments. 4. Verification of the hypothesis that treating at both the remote and the nearby acupoints according to the meridian theory is more effective than treating at only the nearby acupoints. Methods : 1. Research designed as Single blind, Randomized, Sham acupuncture controlled clinical Trial. 2. Assignment of 86 patients to one of three groups treated at nearby acupoints(group A), remote & nearby acupoints(group B), and sham points(group C) respectively. 3. Trial conducted at KIOM CRC of Dunsan oriental medical hospital, Daejeon Univ. 4. Estimation of the recovery rate of the frozen shoulder in subjects aged over 40. 5. Efficacy evaluation using VAS, SPADI, ROM and Improvement rate. Results : 1. There was no significant difference in VAS among the three groups. 2. Pain related scores in SPADI of the group B were significantly lower than those of the group A. 3. There was no significant difference in disability related scores of SPADI among the three groups. 4. External rotation of upper arm in the group B was significantly improved in comparison with that in the group C. 5. Abduction of upper arm in group A was improved with weak statistical significance in comparison with that in the group C. Conclusion : Acupuncture at both the remote and the nearby acupoints according to the meridian theory is effective to improve external rotation of frozen shoulder, and acupuncture at the nearby acupoints is effective to improve adduction of frozen shoulder. However it is not clear that acupuncture treatment at both the remote and the nearby acupoints according to the meridian theory is more effective than treating at only the nearby acupoints in the treatment of frozen shoulder. Since our study was a short term trial, a long term trial for a more precise evaluation of acupuncture treatment for frozen shoulder will be needed in the future.

• Korean Journal of Radiology
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• 제21권1호
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• pp.68-76
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• 2020

Objective: To survey care providers' willingness to use 2-mSv computed tomography (CT) in their usual practice for adolescents and young adults with suspected appendicitis. Materials and Methods: An ethical committee approved this prospective study. We introduced 2-mSv CT in 20 hospitals through a pragmatic clinical trial. At the final phase of the trial, we invited 698 potentially-involved care providers in the survey regarding their willingness to use 2-mSv CT. Multivariable logistic regression analyses were performed to identify factors associated with willingness. Nine months after the completion of the trial patient recruitment, we surveyed whether the hospitals were using 2-mSv CT in usual practice. Results: The analyses included responses from 579 participants (203 attendings and 376 trainees; 221 radiologists, 196 emergency physicians, and 162 surgeons). Regarding the willingness to immediately change their standard practice to 2-mSv CT, 158 (27.3%), 375 (64.8%), and 46 (7.9%) participants responded as "yes" (consistently), "partly" (selectively), and "no", respectively. Willingness varied considerably across the hospitals, but only slightly across the participants' departments or job titles. Willingness was significantly associated with attendings (p = 0.004), intention to maintain the dedicated appendiceal CT protocol (p < 0.001), belief in compelling evidence on the carcinogenic risk of conventional-dose CT radiation (p = 0.028), and hospitals having more than 1000 beds (p = 0.031). Fourteen of the 20 hospitals kept using 2-mSv appendiceal CT in usual practice after the trial. Conclusion: Despite the extensive efforts over the years of this clinical trial, many care providers were willing to use 2-mSv CT selectively or not willing to use.

• 한방비만학회지
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• 제24권1호
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• pp.87-93
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• 2024

Objectives: Obesity is a globally prevalent public health issue. Hence, there is a need for the development of safer and more effective anti-obesity drugs. Lythrum salicaria, a traditional medicinal herb used for centuries, has been reported to improve lipid metabolism and fat accumulation. It also has a low toxicity profile. Therefore, its potential as a functional ingredient in health functional foods needs to be evaluated. Methods: In this randomized, double-blind, placebo-controlled clinical trial, 90 participants will be randomly assigned to either the experimental or control group. Each subject will orally receive L. salicaria extract (1,350 mg/day) (500 mg L. salicaria+850 mg lactose as vehicle) or lactose (1,350 mg/day) as a hard capsule formula for 84 days (12 weeks). The primary outcome will be body fat mass (kg), which will be assessed using dual-energy x-ray absorptiometry (DXA) (performed only at visits 2 and 4). Secondary outcomes include body mass index, body weight, waist-to-hip ratio, body fat percentage (%) measured using DXA, lean body mass (kg) measured using DXA (assessed only at visits 2 and 4), lipids (total cholesterol, triglyceride, high-density lipoprotein cholesterol, and calculated low-density lipoprotein cholesterol), free fatty acid, high sensitivity C-reactive protein, adiponectin, and leptin. Conclusions: This protocol will be implemented after approval of Institutional Review Board of Pusan National University Korean Medicine Hospital (approval number: PNUKHIRB-2022-08-002) and registration with the Korean National Clinical Research Information Service (CRIS) (CRIS-KCT0008060). The results of this trial will provide potential of L. salicaria as a new anti-obesity functional food with fat-reducing effects and low toxicity.