• 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.

• The Journal of Korean Medicine
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• v.38 no.3
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• pp.124-142
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• 2017

Objectives: This study aimed to learn what should be considered in [Guideline of Clinical Trial with Herbal Medicinal Product for Gastric Cancer)] by analyzing the existing guidelines and clinical trials. Methods: The development committee searched guidelines for herbal medicinal product or gastric cancer developed already. Then, clinical trials for gastric cancer using herbal medicine were searched. The searched trials were analyzed in terms of inclusion and exclusion of participants, intervention, comparator, outcomes and trial design. Then, we compared the results of analysis with the regulations and guidelines of Ministry of Food and Drug Safety to suggest the issue that we will have to consider when making the [Guideline of Clinical Trial with Herbal Medicinal Product for Gastric Cancer]. Results: As a result, few guidelines for anti-tumor agent and clinical trial with herbal medicinal product were searched in the national institution homepage. In addition, 10 articles were searched by using the combination following search term; 'stomach neoplasm', 'herbal medicine', 'Medicine, Korean traditional', 'Medicine, Chinese Traditional', 'TCM', 'TKM', 'trial'. Most trials included gastric cancer participants with medical history of operation. The type of intervention was various such as decoction, granules, and fluid of intravenous injection. Comparators were diverse such as placebo, conventional treatment including chemotherapy and nutritional supplement. The most frequently used outcome for efficacy was quality of life. Besides, the symptom score, tumor response, and survival rate were used. Safety was investigated by recording adverse events. Conclusion: We found out some issue by reviewing the existing guidelines and comparing it with clinical trials for gastric cancer and herbal medicinal products. These results will be utilized for developing [Guideline of Clinical Trial with Herbal Medicinal Product for Gastric Cancer].

• Journal of Korean Biological Nursing Science
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• v.16 no.4
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• pp.267-275
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• 2014

Purpose: The practice of enteral nutrition with gastric residual volumes (GRVs) as a clinical indicator is poorly standardized in intensive care units. This study aims to summarize the results from studies that evaluated the clinical outcomes related to the GRVs. Methods: This systematic review study analyzed 11 studies consisting of four randomized controlled trials, one non-randomized controlled trial, and six observational studies. Results: No consistent relationship between GRV thresholds and clinical outcomes was observed. Higher GRVs were not consistently correlated with clinical outcomes such as higher gastrointestinal complications, aspiration pneumonia, or mortality. Higher GRVs significantly generate complications more often. Findings show that a single GRV more than 200 mL or two consecutive GRVs more than 150 mL should raise concern about negative consequences. Conclusion: Critical care nurses need to monitor GRVs closely during their practice of enteral nutrition. For critically ill patients receiving enteral nutrition, a GRV threshold of 200 ml would be a desirable limit to provide safe and adequate nutrition with a conservative approach.

• The Journal of Pediatrics of Korean Medicine
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• v.29 no.4
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• pp.119-126
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• 2015

Objectives The purpose of this study is to investigate recent clinical studies on effect of acupuncture for Autism Spectrum Disorder in other countries. We have analyzed the studies on effect of acupuncture for Autism Spectrum Disorder within randomized controlled trail (RCT) for 6years (from 2010 to 2015). Methods The search database includes Medline, Embase, Cochrane library and CNKI (China National Knowledge Infrastructure). To narrow the search, the following key search terms were used: 'autism or ASD or Asperger's Syndrome or pervasive developmental disorder, acupuncture'. The search was limited to the publication date from 2010 to 2015. 7 control studies in Medlin, Embase, Cochrane library and 5 control studies in CNKI were selected for analysis. Results and Conclusions 1. The acupuncture and rehabiliation treatment is more effective than only acupuncture treatment. Especially, Retention of needling is helpful. 2. It is necessary to set up standard scale in assessment of ASD patients and serum arginine-vasopressin (AVP) can be substitution. 3. Head acupuncture and tongue acupuncture is effective for ASD.

• The Journal of Korean Medicine
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• v.31 no.4
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• pp.1-8
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• 2010

Objective: The study aimed to review all randomized controlled clinical trials (RCTs) performed in Korea with herbal medicine, to produce further useful information for herbal-drug development. Methods: All papers reporting RCT with herbal drugs were collected via public database of Korea Science and Technology Integration Services, and various Oriental medicine journals. Then, the clinical question, herbal medicine, result, RCT design, and its conductor were analyzed. Results: A total of 20 RCTs were finally selected, and most of them were performed after 2003. The main subjects of RCT were related to heart and blood circulation, dermatitis, respiration disorder, Sasang constitution, or psychiatric disorders. Eight RCTs were done with a single herb while 12 RCTs were with multiple herbal formulae. In particular, three RCTs for atopic dermatitis with three formulae showed positive results. The quality of RCT was considered as better than average. Conclusions: This study revealed the current status of RCT using herbal drugs. This result would provide helpful information for research and drug development using traditional herbal medicine.

• The Journal of Pediatrics of Korean Medicine
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• v.30 no.2
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• pp.23-30
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• 2016

Objectives The purpose of this study is to investigate recent clinical studies on effect of acupuncture for strabismus in Korea and other countries. We have analyzed 10 years (from 2006 to 2015) of case studies and randomized controlled trials (RCT) on effect of acupuncture for strabismus. Methods The search database includes Oasis, KTKP (Korean Traditional Knowledge Portal), Medline, Embase, and Cochrane library. To narrow the search, the following key search terms were used: 'strabismus, acupuncture'. The search was limited to the publication date from 2006 to 2015. 7 case studies and 5 control studies were selected for analysis. Results and Conclusions 1. The acupuncture treatment is effective for paralytic strabismus 2. The studies used BL1, GB1, ST2, TE23, GB15, EX-HN5, ST1, and LI4 acupoints and also an electroacupuncture treatment, which is 15 minutes of extraocular muscle stimulation, was used. 3. Degree of strasbismus was tested by Ocular motor range test, Corneal light reflex test, Ocular abducent scale test (Scott and Kraft, Diploptic range test).

• Journal of Ginseng Research
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• v.46 no.4
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• pp.543-549
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• 2022

Background: In physical activity or labor, the human body is in a state of high intensity stress, and all parts or physiological functions of the body respond positively to maintain or balance the need for movement. The human body has many physiological changes in the process of movement, and fatigue is the external manifestation of various complex changes inside the human body. Fatigue is also a physiological mechanism of self-protection after the body reaches a certain level of activity, which can prevent the occurrence of life-threatening excessive functional failure. The generation of fatigue is a very complex process, and its mechanism has not been concluded yet. Therefore, it is an important work to search and screen the effective components of natural plants that have anti-fatigue effect and to explore their mechanism. Methods: This was a 8-week, randomized, double-blind, placebo-controlled clinical trial. A total of 110 subjects who passed physical examination were included according to the scheme design, and randomly divided into a test group which was given KRG and a placebo control group. The calculation is carried out according to the standard of sub-high-intensity exercise test. Results: There was no adverse effect on safety index of subjects after taking red ginseng capsule. After KRG treatment, subjective strength grade is significant lower than placebo treatment. Blood lactic acid content is significantly get lower after trial in KRG group, and significant lower than placebo group. Creatine phosphokinase(CK) content is significantly get lower after trial in KRG group, and significant lower than placebo group. Conclusion: According to the criterion in the test scheme, the result shows that KRG is helpful on relieving physical fatigue.

• Nutrition Research and Practice
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• v.16 no.4
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• pp.450-463
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• 2022

BACKGROUND/OBJECTIVES: Adolescents who skip breakfast have an increased prevalence of chronic diseases. Thus, we aimed to evaluate whether the intake of rice-based breakfast had positive effects on blood glucose indices and to determine the possibility of diabetes prevalence in Korean youths who habitually skip breakfast. SUBJECTS/METHODS: In this randomized parallel-group controlled trial, 81 subjects who were suitable for compliance among 105 middle-and high-school students aged 12-18 years who usually skipped breakfast were included in this study (rice-meal group [RMG], n = 26; wheat-meal group [WMG], n = 29; general-meal group [GMG], n = 26). The RMG and WMG received a rice-based breakfast and a wheat-based breakfast for 12 weeks, respectively. The anthropometric indices, blood glucose indices, and metabolites were measured at baseline and the endpoint, respectively. RESULTS: The mean body weights in the RMG, WMG, and GMG groups at the endpoint were 62.44 kg, 61.80 kg, and 60.28 kg, respectively, and the mean body weights of the WMG and GMG groups at the endpoint were significantly higher than that at baseline (P < 0.05). The levels of fasting insulin and homeostasis model assessment of insulin resistance (HOMA-IR) values were significantly decreased in the RMG group at the endpoint compared to baseline (P < 0.05, P < 0.05, respectively). The levels of tryptophan and tyrosine in the WMG group at the endpoint were significantly higher than that those at baseline (P < 0.01, P < 0.05, respectively). CONCLUSIONS: Rice-based breakfast has positive effects on fasting insulin levels and HOMA-IR in Korean adolescents who skip breakfast. Additionally, it was found that a skipping breakfast could increase the prevalence of diabetes in adolescents who skip breakfast. Therefore, in addition to reducing breakfast skipping, it is vital to develop a rice-based menu that fits teenage preferences to prevent chronic diseases such as diabetes.

• Journal of Periodontal and Implant Science
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• v.50 no.2
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• pp.83-96
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• 2020

Purpose: The present study aimed to evaluate the clinical benefit of additional toothbrushing accompanying non-surgical periodontal treatment on oral and general health in patients with type 2 diabetes mellitus (T2DM). Methods: We conducted a doubled-blind randomized controlled trial in 60 T2DM patients between June 2013 and June 2014. The patients were randomly assigned to the scaling and root planing (SRP) group; the scaling and root planing with additional toothbrushing (SRPAT) group, in which additional toothbrushing was performed by toothpick methods; or the control group. Microbiological and oral examinations were performed for up to 12 weeks following treatment. Non-surgical treatment was conducted in the experimental groups. The SRP group received scaling and root planing and the SRPAT group received additional toothbrushing with the Watanabe method once a week from the first visit through the fifth visit. The primary outcomes were changes in haemoglobin A1c (or glycated haemoglobin; HbA1c) levels, serum endotoxin levels, and interleukin-1 beta levels. Periodontal health status was measured by periodontal pocket depth, the calculus index, and bleeding on probing (BOP). Results: Both the SRP and SRPAT groups showed improvements in periodontal health and HbA1c, but the SRPAT group showed significantly less BOP than the SRP group. Furthermore, only the SRPAT group showed a statistically significant decrease in serum endotoxin levels. Conclusions: Non-surgical periodontal treatment was effective in improving HbA1c and serum endotoxin levels in T2DM patients. Furthermore, non-surgical treatment with additional tooth brushing had a more favourable effect on gingival bleeding management. Trial RegistrationClinical Research Information Service Identifier: KCT000416.