• 제목/요약/키워드: double blind

검색결과 538건 처리시간 0.028초

Prophylactic antibiotics in intra-oral bone grafting procedures: a prospective, randomized, double-blind clinical trial

  • Lee, Jung-Woo;Lee, Jin-Yong;Kim, Soung-Min;Kim, Myung-Jin;Lee, Jong-Ho
    • Journal of the Korean Association of Oral and Maxillofacial Surgeons
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    • 제38권2호
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    • pp.90-95
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    • 2012
  • Objectives: This study was conducted in order to assess the efficacy of 1st generation cephalosporin as use as a single-dose preoperative prophylactic antibiotic for surgical wound infections resulting from intra-oral bone grafting procedures. Materials and Methods: A total of 23 patients who were to undergo intra-oral bone graft procedures participated in this study. After randomization, 2 grams of 1st generation cephalosporin was orally administered to both the experimental and placebo groups one hour prior to surgery in a double-blind fashion. Post-operatively, the experimental group (12 patients) was orally administered placebo three times a day for three days. The control group (11 patients) was orally administered 1st generation cephalosporin three times a day for three days. The postoperative course was observed for one month including the clinical parameters associated with infection. Results: Postoperative infections were noted in 1 out of 11 patients in the experimental group. No infections occurred in the control group. Conclusion: There was no significant difference in the incidence of postoperative infections between the two groups. Two grams of 1st generation cephalosporin administered orally one hour before surgery served as an effective prophylactic antibiotics therapy for intra-oral bone graft surgery.

체지방에 대한 아로니아 추출물의 효과: 무작위배정, 이중눈가림, 위약-대조 임상연구 (The Effects of Aronia Extract on Body Weight and Body Fat: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial)

  • 하기찬;박유경;백향임;김혜미;김영미;정다영;신상욱;배정식;안지혜;전연정;박지은;권영달
    • 한방재활의학과학회지
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    • 제30권1호
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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.

이중 맹검법을 이용한 홍삼의 노인병 치료에 대한 임상연구 (A DOUBLE-BLIND CLINICAL TRIAL OF PANAX GINSENG IN AGED SUBJECTS)

  • Fulder Stephen;Kataria Mohan;Smith Beryl Gethyn
    • 고려인삼학회:학술대회논문집
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    • 고려인삼학회 1984년도 학술대회지
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    • pp.215-223
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    • 1984
  • 인삼이 노령자의 피로 및 쇠약 치료효과에 미치는 영향을 연구하기 위해 런던의 성프란시스병원과 지방의 일반 개업 병인으로부터 50명의 노인들을 모집하였다. 매일 2g의 홍삼 분말을 이중맹검법에 의하여 10일간 투약하였으며. 위약과 홍삼 분말의 투여는 3주간의 간격을 두고 각기 투여하였다. 간호원이 10가지 정신측정 종합테스트와 심리측정 테스트를 하였고, 기분상태 및 일반적인 건강평가를 설문지로 측정하였다 이 측정을 홍삼 및 위약의 투여기간을 전후하여 실시하였다. 즉, 각각의 테스트를 모두 4번 실시하였다. 심리측정 테스트와 정신측정 종합테스트 결과 홍삼의 투여는 위약과는 달리, 미약하나마 일관성있는 증가를 가져왔다. 그러나 기분상태 및 일반적인 건강 평가는 별 변화가 없었다. 결론적으로 인삼은 강장효과를 갖는다 할 수 있다. 노인병 치료를 평가함에 있어 시도방법 및 기간 등에 의하여 약효의 평가가 모호해지는 경우가 종종 있다. 보다 적절한 임상시험법에 대하여 토론하고자 한다.

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마황복용이 성인의 체중감소에 미치는 영향에 대한 이중맹검 임상연구 (Effects of Mahuang for Weight Loss in Healthy Adults : A Double-Blind, Controlled, Randomized, Clinical Trial)

  • 여진주;형례창;양창섭;정승일;서의석;장인수
    • 대한한의학회지
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    • 제28권1호통권69호
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    • pp.63-71
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    • 2007
  • Objectives : To provide an objective assessment of the effectiveness for weight loss of Mahuang. Methods : Effects were assessed by measuring changes in body weight, body mass index (BMI), body fat (kg, %),body muscle, and abdominal f3t ratio. The subjects of this study were healthy adults who agreed to participate in this study. Eligibility requirements include age between 20 and 50 and BMI more than 18.5 kg/m2. One hundred subjects were randomly assigned to two groups (control and Mahuang group) in a double-blind manner. Mahuang group subjects took 8g of Mahuang capsule/day for two weeks; control subjects took the same amount of indistinguishable placebo. We analyzed the body weight, body mass index, body fat, abdominal fat, body muscle and BMR (basal metabolic rate) before and after the study. Result After two weeks of clinical trial, body weight and BMI decreased in both groups, but the Mahuang group showed more significant decrease. On body fat, the Mahuang group showed significant decrease. while it increased in the placebo group. Although body muscle, body fat ratio and basic metabolic rate showed differences between the two groups, there was no statistical significance. Conclusion : It is suggested that intake of Mahuang may induce weight loss and body f3f decrease in healthy adults.

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산조인 복합오일을 이용한 향기건식 흡입요법과 스파 프로그램이 스트레스에 미치는 효과 : 이중맹검, 무작위배정, 단일기관 임상시험 (Efficacy of Inhalation Therapy using Zizyphus jujuba var. spinosa Blended Oil and Spa Therapy on Stress : A Double-blind, Randomized, Single center Clinical Trial)

  • 오서영;강재희;장태수;최희정;안택원
    • 혜화의학회지
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    • 제26권1호
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    • pp.49-57
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    • 2017
  • Objectives : The purpose of this study was to investigate the efficacy of inhalation therapy using Zizyphus jujuba var. spinosa blended oil and spa therapy on stress in adults. Methods : The study design was a double blind, randomized, single center clinical trial. A total of 30 volunteers who were highly stressed and were over 9 points on POMS(profile of mood states) participated in this study. Inhalation therapy using Zizyphus jujuba var. spinosa blended oil and spa therapy were applicate for the experimental group and Jojoba oil inhalation and spa therapy was given for the control group. During the 2 weeks, the participants were treated about inhalation and spa therapy twice a week. The treatment sequence is spa therapy after inhalation therapy. Result : The improvement of stress was evaluated by POMS, HRV(Heart Rate Variability), EEG(Electroencephalography), PSQI(Pittsburgh Sleep Quality Index), salivary cortisol. After treatment, POMS was significantly decreased between the experimental group and the control group. In other measurement(HRV, EEG, PSQI, salivary cortisol) except POMS, there were not significant. Overall, however, they showed a tendency to alleviate stress in the experimental group. Conclusions : We suggest that inhalation therapy using Zizyphus jujuba var. spinosa blended oil and spa therapy might be effective on stress.

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Effects of a mouthwash containing potassium nitrate, sodium fluoride, and cetylpyridinium chloride on dentin hypersensitivity: a randomized, double-blind, placebo-controlled study

  • Hong, Ji-Youn;Lim, Hyun-Chang;Herr, Yeek
    • Journal of Periodontal and Implant Science
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    • 제46권1호
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    • pp.46-56
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    • 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.

Post-operative analgesia of 2% lignocaine with or without magnesium sulfate for inferior alveolar nerve block in symptomatic mandibular molars - a randomized double blind controlled clinical trial

  • Chandrasekaran, Charanya;Vijay, Amirtharaj L;Sekar, Mahalaxmi;Mary, Nancy S
    • Journal of Dental Anesthesia and Pain Medicine
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    • 제20권3호
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    • pp.147-154
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    • 2020
  • Background: Single inferior alveolar nerve block is ineffective in achieving adequate pulpal anesthesia in 30-80% of patients due to anatomical variations, local tissue pH, central sensitization, and several factors. Various supplementary techniques and combination of adjuvants with lignocaine are used to overcome these failures. Magnesium sulfate (MgSO4), one such adjuvant, acts at the N-methyl-D-aspartate glutamate receptor resulting in effective anesthesia. The aim of this prospective, randomized, double-blind, clinical controlled trial was to evaluate the onset, anesthetic efficacy, duration and post-operative analgesia of 2% lignocaine with and without the addition of MgSO4 in patients with symptomatic irreversible pulpitis and apical periodontitis. Methods: Fourty-two patients were randomly divided into three groups: 2% lignocaine (group 1) and 2% lignocaine with MgSO4 (75 mg) and (150 mg) in groups 2 and 3, respectively. Pre-operative vitals and Heft Parker-Visual Analogue Scale (HP-VAS) pain scores were recorded. The onset of anesthesia, anesthetic efficacy, and duration of anesthesia were evaluated post administration of the local anesthetic solution. The post-operative analgesia was examined at intervals of 2, 6, 12, 24, and 48 h. Results: Administration of 150 mg MgSO4 hastens the onset of anesthesia (1.29 min) and produces better anesthetic efficacy (3.29 HP-VAS) compared to group 2 (2.07 min and 9.14 HP-VAS) and group 1 (3.29 min and 35.79 HP-VAS), respectively. The duration of anesthesia was significantly higher in group 3 (247.07 min) compared to that of groups 2 and 1 (190 min and 110.21 min) with P < 0.05. Conclusion: Combining 75 mg or 150 mg of MgSO4 with lignocaine is more effective than 2% lignocaine and 75 mg of MgSO4 is adequate for endodontic procedures.

만성 요통 환자에서 박동성 전자기장 치료의 효과: 무작위, 이중맹검, 위약대조법을 이용한 연구 (Efficacy of Pulsed ElectroMagnetic Therapy for Chronic Lower Back Pain: a Double-Blind, Randomized, Placebo-Controlled Study)

  • 이평복;김용철;이상철
    • The Korean Journal of Pain
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    • 제18권1호
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    • pp.43-47
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    • 2005
  • Background: The optimal management of pain using magnetic irradiation modalities continues to attract considerable debate. Therefore, we conducted a randomized, double-blind, placebo-controlled clinical trial to determine the effectiveness of pulsed electromagnetic therapy for the treatment of chronic lower back pain. Methods: Fifteen-minute sessions of active (n = 20) or placebo (n = 20) electromagnetic therapy were repeated 3 times a week for 3 weeks. Patients were assessed using the 11-point numerical rating scale and the revised Oswestry disability scores for up to 4 weeks after therapy. Results: The active magnetic group showed significantly more pain reduction than the placebo group immediately after therapy and one and four weeks after therapy (P < 0.05). At 4 weeks after therapy percentage changes in NRS from baseline were $22{\pm}24%$ and $38{\pm}11%$ in the placebo and magnetic groups, respectively. The revised Oswestry disability percentage in the active magnetic group was also significantly improved (P < 0.05). Conclusions: Pulsed electromagnetic therapy provided pain relief and ameliorated disability in patients with chronic lower back pain. According to our results, pulsed electromagnetic therapy should be considered an important potential therapeutic tool for the conservative therapy of chronic lower back pain.

Monocyte chemoattractant protein-1 polymorphism interaction with spirulina immunomodulatory effects in healthy Korean elderly: A 16-week, double-blind randomized clinical trial

  • Park, Hee Jung;Lee, Hyun Sook
    • Nutrition Research and Practice
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    • 제11권4호
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    • pp.290-299
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    • 2017
  • BACKGROUND/OBJECTIVES: Spirulina is a known a functional food related to lipid profiles, immune functions, and antioxidant capacity. Circulating monocyte chemoattractant protein-1 (MCP-1) level is associated with inflammation markers. Single nucleotide polymorphism in the MCP-1 promoter region -2518 have been identified and shown to affect gene transcription. Gene variation may also impact functional food supplementary effects. The current study investigated the interaction of MCP-1 -2518 polymorphism with spirulina supplements on anti-inflammatory capacity in Korean elderly. SUBJECTS/METHODS: After genotyping, healthy elderly subjects (n = 78) were included in a randomized, double blind, and placebo controlled study. Baseline characteristic, body composition, and dietary intake were measured twice (baseline vs. week 16). For 16 weeks, subjects consumed 8 g either spirulina or placebo daily. Plasma MCP-1, interleukin (IL) -2, IL-6, tumor necrosis factor (TNF)-${\alpha}$, complement (C) 3, immunoglobulin (Ig) G, and Ig A concentrations and lymphocyte proliferation rate (LPR) were analyzed as inflammatory markers. RESULTS: In the placebo group with A/A genotype, MCP-1 level was significantly increased, but the spirulina group with A/A genotype was unchanged. IL-2 was significantly increased only in subjects with spirulina supplementation. TNF-${\alpha}$ was significantly reduced in subjects with the G carrier. C3 was significantly increased in the placebo group, particularly when A/A increased more than G, but not when spirulina was ingested. LPR was significantly different only in subjects with A/A genotype; there was a significant increase in phytohemagglutinin and lipopolysaccharide induced LPR in the spirulina group. CONCLUSION: In healthy Korean elderly, spirulina supplementation may influence different inflammatory markers by the MCP-1 genotype. These results may be useful for customized dietary guidelines to improve immune function in Koreans.

발효굴추출물의 경구 섭취가 소아 신장 성장에 미치는 효과 및 안전성 평가를 위한 무작위배정, 이중눈가림, 위약 대조 인체적용시험: 인체적용시험 프로토콜 (Randomized, Double-blind, and Placebo-controlled a Human Study for Growing of Stature via the Analysis of Effect of Ferment Oyster Extract: Study Protocol)

  • 김희연;박범찬;천진홍;최준용;안병민;박정현;이배진;김기봉
    • 대한한방소아과학회지
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    • 제33권4호
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    • pp.37-46
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    • 2019
  • Objectives The purpose of this study is to confirm the efficacy and safety of the treatment of with fermented oyster extract on height growth in children with short stature. Methods A total of 100 people, between 6 and 11 years old, will be participated in a randomized, double-blind, and placebo-controlled human study. The fermented oyster group will take 500 mg of fermented oyster extract once a day for 24 weeks. The placebo group will take 3400 mg of fructooligosaccharide as placebo once a day for 24 weeks. The outcomes of the intervention will be measured at the baseline, 6 week, 12 week, 18 week, and 24 week. The primary outcome is the changes in height from the baseline. The secondary outcomes are growth rate, height SDS, bone age, GH, IGF-1, IGFBP-3, osteocalcin, BALP, DPD, and LH. Results This trial was approved by the institutional review board of Pusan National University Korean Medicine Hospital (registry number: PNUKHIRB-2019002). Recruitment of the research participants will be opened from May 2019 till December 2019. Conclusions This study will provide clinical information to determine the efficacy and safety of the treatment with fermented oyster extract on height growth in children with short stature.