• Title/Summary/Keyword: Clinical trial,

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A Comparative Study of Clinical Sffects Following Periodontal Surgery with and without Dressing (치주수술후 치주포대의 사용유무에 따른 임상적 효과에 대한 비교논문)

  • Bae, Sang-Bum;Lim, Sung-Bin;Chung, Chin-Hyung
    • Journal of Periodontal and Implant Science
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    • v.29 no.3
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    • pp.693-703
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    • 1999
  • Since they were introduced by Ward in 1923, periodontal dressing have been routinely used following the periodontal surgery to avoid pain, infection, desensitizing teeth, inhibiting food impaction of the surgical areas, and immobilizing injured areas. Recently, however, the value of periodontal dressings and their effects on periodontal wound healing have been questioned, several authors have been reported that the use of dressing has little influence on healing following periodontal surgical procedures. In addition, there is evidence that when good flap adaptation is achieved, the use of a periodontal dressing does not add to patient comfort nor promote healing. The purpose of this study was to evaluate patient postoperative pain experience and discomfort with and without the use of periodontal dressing following periodontal surgery. Twenty-eight patients, 11 male and 17 female. were selected for this study; The age range was 31 to 56, with an average of 40.2years. Patient selection was based on existence of two bilateral sites presenting similar periodontal involvement, as determined by clinical and radiographic assessment, and requiring comparable bilateral surgical procedures. Using a splitmouth dressing. one site received a periodontal dressing while the other site did not. Pain assessment was made according to a horizontal, rating scale(0-10). After at least a two-week period, the second surgical precedure was performed using the alternate postoperative treatment. At the conclusion of the trial, a self-administered questionnaire on postoperative experience was administered, and were asked of their preference of either, dressed or undressed. The results were as follows: 1. A similar trend for mean pain and discomfort scores as assessed by patients both dressed and salinetreated procedures was evident during 7-day postsurgical period. 2. Statistical analysis of differences between the dressed side and salinetreated side with respect to pain, discomfort and patient's experiences revealed that both treatment sides behaved similarly at any postoperative day(P>0.05). 3. Considering the patient's preference, on the basis of pain and discomfort experienced, 43% preferred the saline-mouthwash and 32% preferred the dressing, 25% showing no preference for either the dressing or the saline-mouthwash. There is evidence to support the use of a periodontal dressing in retention of an apically positioned flap by preventing coronal displacement, or its use to provide additional support to stabilize a free gingival graft. However, there will always be a use for periodontal dressing although routine use of dressings may decrease because of better surgical techniques and the use of antibacterial mouth rinses.

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Interim Report about The Effect of Bunsimgi-eum(Fenxinqiyin) on the Chest Discomfort of Hwa-byung's Major Symptom (화병 핵심증상 중 흉민에 대한 분심기음의 효능 : 무작위배정, 이중맹검, 위약대조군연구의 중간보고 - 피험자 특성을 중심으로)

  • Yim, Hyeon-Ju;Kim, Seok-Hwan;Lee, Sang-Ryong;Kang, Wee-Chang;Jung, In-Chul
    • Journal of Oriental Neuropsychiatry
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    • v.20 no.3
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    • pp.169-188
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    • 2009
  • Objectives : The purpose of this research is to examine the effect of Bunsimgi-eum on the chest discomfort of Hwa-byung's major symptom. Methods : In this randomized, double blinded, placebo-controlled study, we planned to give Bunsimgi-eum or controlled medication for major symptoms of Hwa-byung. As preparatory research, 100 mm Visual Analogue Scale(VAS) for chest discomfort, the Hwa-byung' major symptom was measured as the 1st evaluative instrument, and Likert scale for major symptom of Hwa-byung, Korean State-Trait Anger Expression Inventory(STAXI-K), Korean State-Trait Anxiety Inventory(STAI-K), Korean Beck's Depression Inventory(BDI-K) and Heart Rate Variability(HRV) were also measured as the 2nd evaluative instrument at the before treatment. Results : Clinical characteristics-vital signs & demographic characteristics showed no significant difference between both groups. The characteristics of disease-chief complaint, pattern Identification, period, etiological factor, etc, also showed no significant difference between both groups. There were almost no Coincidence between pattern identification & weight of Hwa-byung's major symptoms. The results of Chest PA, EKG and clinicopathologic examination showed no significant difference between both groups. There were no significant difference between both groups in all valuation scales; 100 mm Visual Analogue Scale for chest discomfort, the Hwa-byung' major symptom was measured as the 1st evaluative instrument, and Likert scale for major symptom of Hwa-byung, STAXI-K, STAI-K, BDI-K and HRV. Conclusions : We considered that establishment of experimental group and controlled group was objective and worth conducting this research. And this methodology is expected to be applied to the subsequent research. And also, we hope to make up for this study through various study and discussion.

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The effect of Light Emitting Diode electric toothbrush on gingivitis: a randomized controlled trial (발광 다이오드(Light Emitting Diode) 전동칫솔의 치은염에 대한 효과: 무작위 배정 임상시험)

  • Lee, Sung-Jo
    • Journal of Dental Rehabilitation and Applied Science
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    • v.33 no.2
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    • pp.119-126
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    • 2017
  • Purpose: The aim of the present study was to compare clinical antiplaque and antigingivitis effect between Light Emitting Diode (LED) electronic toothbrush and electronic toothbrush without LED for gingivitis and mild periodontitis patients. Materials and Methods: 30 patients included in this study. 15 patients in experimental group used LED electronic tooth brush which has red and white LED within its head, and other 15 patients in control group used same product which specially modified that function without LED. Clinical parameters ($L{\ddot{o}}e-Silness$ gingival index (GI), Quigley-Hein plaque index (PI)) were measured at the baseline, 2 weeks and 4 weeks later. Wilcoxon signed rank test and Mann-Whitney test were used for statistical analysis. Results: Compare of GI change between experimental and control group with time, both groups showed that reduced GI, but lower GI values detected at 2 weeks and 4 weeks later in experimental group than control group. And lower PI values detected at 4 weeks later in experimental group than control group, but not statistically significant. Conclusion: Based on these results and within the limits of this study, the electronic toothbrush with LED could reducing gingivitis in a short period and infer that decreasing plaque accumulation in a long period.

Clinical Efficacy of Clozapine in Refractory Schizophrenia (불응성 정신분열증환자의 Clozapine 치료효과)

  • Lee, Min-Soo;Jung, In-Kwa;Kwak, Dong-Il
    • Korean Journal of Biological Psychiatry
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    • v.2 no.1
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    • pp.131-139
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    • 1995
  • Clozapine, on atypical antipsychotic drug, has been estimated to be a major improvement in the treatment-refractory schizophrenic patients. We evaluated the clozapine efficacy in the treatment of schizophrenic patients who are refractory to classic neuroleptics. The patients were assigned in a prospective, open, comparative trial for 12 weeks. Following an dose titration, 33 inpatients with treatment-refractory schizophrenia diagnosed according to DSM-III-R were given a clozapine(N=17, approximate 300-600mg/day) or haloperidol(N=16, approximate 20-30 mg/day) for 12 weeks. The clinical state was assessed before treatment, and 1st, 4th, 8th and 12th week during treatment using Brief Psychiatric Rating Scale(BPRS) and Positive and Negative Syndrome Scale(PANSS). Assessment of side effects were mode weekly using Simpson-Angus Scale for Extrapyramidal Side Effects and Adverse Events-Somatic Symptoms. Clozapine produces significant improvement than haloperidol on the BPRS and PANSS scores. 77% (13/17) of the clozapine-treated patients were categorized as responders, who showed at least 20% decrease in total BPRS scores, compared with 31% (5/16) of haloperidol-treated patients. Extrapyramidal side effects occurred in only one patient in clozapine group, but nine patients in haloperidol group. Salivation, sleepiness, constipation and hypotension were most frequent adverse effects observed in clozapine group. There was no significant changes in total WBC and neutrophil during clozapine treatment. These findings suggest that clozapine is on effective antipsychotic drug for the Korean treatment-refractory schizophrenic patients, who are nonresponsive to or unable to tolerate classcal antipsychotic drugs due to extrapyramidal side effects.

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Applicability and Safety of in Vitro Skin Expansion Using a Skin Bioreactor: A Clinical Trial

  • Jeong, Cheol;Chung, Ho Yun;Lim, Hyun Ju;Lee, Jeong Woo;Choi, Kang Young;Yang, Jung Dug;Cho, Byung Chae;Lim, Jeong Ok;Yoo, James J.;Lee, Sang Jin;Atala, Anthony J.
    • Archives of Plastic Surgery
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    • v.41 no.6
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    • pp.661-667
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    • 2014
  • Background Tissue expansion is an effective and valuable technique for the reconstruction of large skin lesions and scars. This study aimed to evaluate the applicability and safety of a newly designed skin expanding bioreactor system for maximizing the graft area and minimizing the donor site area. Methods A computer-controlled biaxial skin bioreactor system was used to expand skin in two directions while the culture media was changed daily. The aim was to achieve an expansion speed that enabled the skin to reach twice its original area in two weeks or less. Skin expansion and subsequent grafting were performed for 10 patients, and each patient was followed for 6 months postoperatively for clinical evaluation. Scar evaluation was performed through visual assessment and by using photos. Results The average skin expansion rate was $10.54%{\pm}6.25%$; take rate, $88.89%{\pm}11.39%$; and contraction rate, $4.2%{\pm}2.28%$ after 6 months. Evaluation of the donor and recipient sites by medical specialists resulted in an average score of 3.5 (out of a potential maximum of 5) at 3 months, and 3.9 at 6 months. The average score for patient satisfaction of the donor site was 6.2 (out of a potential maximum of 10), and an average score of 5.2 was noted for the recipient site. Histological examination performed before and after the skin expansion revealed an increase in porosity of the dermal layer. Conclusions This study confirmed the safety and applicability of the in vitro skin bioreactor, and further studies are needed to develop methods for increasing the skin expansion rate.

Effect of xylooligosaccharide-sugar mixture on defecation frequency and symptoms in young women with constipation: a randomized, double-blind, placebo-controlled trial (자일로올리고당을 함유한 설탕이 20대 여성의 변비 개선에 미치는 효과: 이중맹검 연구)

  • Jeon, Jin Ho;Kyung, Myungok;Jung, Sangwon;Jo, SungEun;Chang, Moon-Jeong
    • Journal of Nutrition and Health
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    • v.48 no.1
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    • pp.19-29
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    • 2015
  • Purpose: To investigate the effects of the intake of xylooligosaccharide-sugar mixture (XOS) on defecation frequency and symptoms in 56 young women (mean age of 22.1 years old) with constipation. Methods: Two experiments were conducted. In experiment 1, a randomized double-blind study was performed to evaluate the effect of 6 weeks' intake of 10 g sucrose containing 7% xylooligosaccharide or 10 g sucrose on constipation. In experiment 2, 24 g coffee mixture containing 12.8 g plant cream and 11.2 g xylooligosaccharide-sugar mixture was consumed by the subjects. During the study, the clinical efficacy was assessed by using a daily diary. The subjects indicated the number of frequencies they defecated in a day and the clinical symptom scores. Results: In experiment 1, the mean frequency of defecations was 2.07 in the pretreatment week and increased significantly to 4.05, 4.42, 4.84, 4.84, and 4.05 in weeks 2 to 6 of XOS intake, in comparison with the 3-3.67 with sucrose intake (sucrose, SUC). In experiment 2, the mean frequency of defecations significantly increased from 2.47 in the pretreatment week to 4.11-5.67 in weeks 1-6 of XOS intake. The occurrence of very loose or loose stools in the XOS group was significantly increased in weeks 5 and 6, compared with the pretreatment week and SUC group. XOS intake significantly alleviated the abdominal displeasure and feeling of residual stool leftness in weeks 2, 3, 5, and 6, while SUC did so in weeks 4 and 6 (p < 0.05). The coffee mixture containing xylooligosaccharide-sugar mixture reduced the abdominal displeasure and feeling of residual stool leftness from week 3 until the end of the experiment (p < 0.05). Conclusion: Our results suggest that xylooligosaccharide-sugar mixture intake was effective, without adverse effects, for the alleviation of constipation in the young women in this study.

Chunghyul-dan for the Prevention of Stroke Progression in Silent Brain Infarction (무증후성 뇌경색 환자에 대한 청혈단(淸血丹)의 중풍예방효과)

  • Cho Ki-Ho;Ji Nam-Gue;Jung Woo-Sang;Park Seong-Uk;Moon Sang-Kwan;Ko Chang-Nam;Kim Young-Suk;Bae Hyung-Sup
    • The Journal of Korean Medicine
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    • v.26 no.2 s.62
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    • pp.77-84
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    • 2005
  • Objectives: Chunghyul-dan is a combinatorial herbal medicine, and previous studies reported it had therapeutic effects for microangiopathy, which is a major part. in the progression of stroke, as well as having anti-hypertensive, anti-hyperlipidemic, anti-apoptotic, anti-oxidative, and anti-inflammatory activities, Therefore, we examined the inhibitory effect of Chunghyul-dan on stroke occurrence in patients with silent brain infarction. Methods: We prescribed Chunghyul-dan at 600 mg a day to patients with silent brain infarction confirmed by brain MRI, and monitored stroke occurrence, drug compliances, and adverse effects for 1 year, We then performed follow-up brain MRI to detect new vascular lesions after 1 year of Chunghyul-dan medication. As for the subjects lost to follow-up, we assessed their prognosis after 1 year by telephone. Results: There were twenty-one subjects who were treated with Chunghyul-dan for more than 1 year, None of them experienced new clinical syndromes characterized by rapidly developing clinical symptoms and signs of focal and at times global loss of brain function, which could be accompanied with evidence of stroke occurrence, or any adverse effects during the Chunghyul-dan medication period. These results might be explained by various biochemical effects of Chunghyul-dan on microangiopathy, which is closely related with cell cycle progression, hypertension, hyperlipidemia, vascular inflammation, and oxidative damage. Of the 10 subjects lost to follow-up, six were reached; two of them had stroke occurrence. Conclusions: We suggest Chunghyul-dan could be useful for prevention of stroke occurrence in patients with silent brain infarction by preventing the progression of microangiopathy. Further study with a randomized controlled trial is needed to confirm this suggestion.

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A Crossover Clinical Trial to Determine the Effect of Siguan(Four Gates) Points on Gastrointestinal Motility Suppressed by Loperamide Administration (Loperamide로 억제된 위장관 운동에 대한 사관혈의 자침효과: 무작위배정, 단일눈가림, 교차설계, 대조 임상시험)

  • Oh, Dal-Seok;Jung, So-Young;Kim, Ae-Ran;Kang, Wee-Chang;Park, Ji-Eun;Koo, Chang-Mo;Choi, Jun-Yong;Jung, Hee-Jung;Choi, Sun-Mi;Son, Chang-Gue
    • The Journal of Korean Medicine
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    • v.29 no.1
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    • pp.1-6
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    • 2008
  • Objective : To investigate the therapeutic effect of manual acupuncture at Siguan (four gates, bilateral LI4 and LR3) on suppression of gastrointestinal motility. Methods : A single blind, randomized, sham-acupuncture controlled, crossover study was conducted. Twenty healthy male subjects were admitted at hospital, and gastrointestinal motility suppression was induced by loperamide administration. Just after intake of 20 radio-markers, four gates or sham acupoint treatments were administered every 12 hours, 4 times over 48 hours. Gastrointestinal motility was evaluated by radiographic distribution of the radiomarkers at stomach or ileum, ascending, transverse, descending colon, sigmoid/rectum, and outside body at serial time points (0, 6, 12, 24, and 48 h). Results : Four gates acupuncture activated gastrointestinal movement as evidenced by significantly changed distributionof radio-makers at 6, 12, and 48 hours (P < 0.0001, P = 0.001, and P = 0.03, respectively) in Cochran-Mantel-Haenszel statistics. No serious adverse events occurred in either group. Conclusions : This study showed a scientific clinical relevance of four gates acupuncture to gastrointestinal disorders.

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Herbal Medicine (Hyeolbuchukeo-tang, Xuefu Zhuyu Decoction) for Insomnia Disorder: A Systematic Review and Meta-analysis of Randomized Controlled Trials (불면장애에 대한 혈부축어탕의 체계적 문헌 고찰 및 메타분석 연구)

  • Kim, Dong-Hee;Lee, Seung-Hwan;Lim, Jung-Hwa;Kim, Sang-Ho;Lee, Sang-Hyup;Kim, Bo-Kyung
    • Journal of Oriental Neuropsychiatry
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    • v.28 no.4
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    • pp.319-332
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    • 2017
  • Objectives: The present study aimed to provide clinical evidence on the effect of herbal medicine, Hyeolbuchukeo-tang or Xuefu Zhuyu decoction for the treatment of primary insomnia using a systematic review and meta-analysis of randomized controlled trials (RCTs). Methods: This study included RCTs that verified the effects of Hyeolbuchukeo-tang or Xuefu Zhuyu decoction for the treatment of primary insomnia. Literature searches of English, Chinese and Korean databases were performed, and the selected literature was assessed for investigating the risk of bias. Results: The analysis included 10 RCTs. The Chinese Classification of Mental Disorders-3 was most frequently used to define the diagnostic criteria for Hyeolbuchukeo-tang or Xuefu Zhuyu decoction intervention in patients with primary insomnia. The effective rate was the most commonly used outcome measure. A meta-analysis revealed that the effective rate, the Pittsburgh Sleep Quality Index, and the Athens Insomnia Scale in the Modified Xuefu Zhuyu decoction (MXZD) group were higher compared to Western Medicine (WM) group (RR: 1.17, 95% Cl: 1.08 to 1.26, p<0.0001, $I^2$=0/MD: -1.29, 95% Cl: -2.09 to -0.49, p=0.002, $I^2$=0%/MD: -0.99, 95% Cl: -1.81 to -0.18, p=0.02, $I^2$=15%). The effective rate of the MXZD+WM group was significantly different compared to the WM group (RR: 1.28, 95% Cl: 1.11 to 1.47, p=0.0006, $I^2$=2%). The included RCTs were of relatively poor quality and had small sample sizes. Conclusions: Treatment with Hyeolbuchukeo-tang or Xuefu Zhuyu decoction was found to be effective in treating primary insomnia. However, the included RCTs were of relatively poor quality and had small sample sizes. It is hypothesized that this study could serve as a foundation for further clinical studies on the development of diagnosis and treatment methods for primary insomnia based on Korean medicine.

Clinical Investigation and Follow-up Monitoring of Fatigue Patients Visiting the Oriental Medical Hospital (한방병원 보양클리닉에 내원하는 피로환자의 임상적 분석 및 치료경과 관찰)

  • 이종훈;이지현;박신명;김영철;이장훈;우홍정
    • The Journal of Korean Medicine
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    • v.21 no.4
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    • pp.55-63
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    • 2000
  • Objectives : Fatigue is a common symptom experienced by everyone. Nevertheless, clinicians have a tendency of ignoring it since fatigue itself is not considered a distinct disease. Actually, some limited research about chronic fatigue syndrome has been made within the country, but in reality, the probability of getting this syndrome is still considered very low due to the strict diagnosis standard. Therefore, there are tremendous numbers of patients who do not get enough attention from clinicians for their fatigue symptoms only because technically they do not belong to the syndrome. Therefore, a basic statistical database must be compiled and patient management programs must be developed. To accomplish this, we conducted this study by measuring degree of fatigue, clinical characteristics and processes of Oriental medical treatment of fatigue patients. Methods : The objects of this study were selected from the new patients who entered the tonification Clinic in Kynnghee Oriental Medical Center between August 11, 2000 and October 7, 2000. Their main complaint was fatigue and they did not suffer from any physical or mental problem either historically or at the time of the study. The objects were divided into two groups based on duration of fatigue; fatigue under 6 months is considered as acute fatigue and fatigue for longer than 6 months is chronic fatigue. The prepared survey sheet for measuring fatigue degree was distributed to the patients with their consent. The patients were divided again into three subgroups : the fIrst group went through 1st test and constitution test after tonification clinic; the second one went into constitution test skipping Ist measuring test; the third one went into only tonification clinic with neither 1st measuring test nor constitution test. Results : The total number of object patients was 47 and 80% of them were considered as 'fatigue patients' by the Chalder scale. Among all patients, 29.5% requested treatment for chronic fatigue, which is over 6 months. The average of scale II for all patients was 14.8, which indicates moderate fatigue. The averages of scale II-1, II-2, II-3 were respectively 7.5, 5.9, and 3.7 so the most common complaint was physical fatigue. When compared scale II based on occupations, student group scored 6.9 and office man group scored 8.5 in scale II-1, physical fatigue, but it was not significant. Conclusions : Numerous number of patients have come to Oriental medical centers or hospitals in Korea. Therefore, deeper statistical research and follow-up-monitoring are reqnired in the Oriental medical academic world. In this study, among all patients who entered the tonification Clinic in Kyunghee Oriental Medical Center, 29.5% requested treatment for chronic fatigue, which is over 6 months. This kind of statistical report is the first time trial in the Oriental medical academy world. Through these steps, more objective treatment can be made and standards of prognosis assessment can be established.tablished.

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