• Title/Summary/Keyword: randomized clinical trial

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Rice-based breakfast improves fasting glucose and HOMA-IR in Korean adolescents who skip breakfast, but breakfast skipping increases aromatic amino acids associated with diabetes prediction in Korean adolescents who skip breakfast: a randomized, parallel-group, controlled trial

  • Kim, Hyun Suk;Jung, Su-Jin;Jang, Soyoung;Kim, Min Jung;Cha, Youn-Soo
    • 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.

Efficacy of non-surgical treatment accompanied by professional toothbrushing in the treatment of chronic periodontitis in patients with type 2 diabetes mellitus: a randomized controlled clinical trial

  • Lee, Jae Young;Choi, Yoon Young;Choi, Youngnim;Jin, Bo Hyoung
    • 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.

Efficacy and safety of Panax ginseng berry extract on glycemic control: A 12-wk randomized, double-blind, and placebo-controlled clinical trial

  • Choi, Han Seok;Kim, Sunmi;Kim, Min Jung;Kim, Myung-Sunny;Kim, Juewon;Park, Chan-Woong;Seo, Daebang;Shin, Song Seok;Oh, Sang Woo
    • Journal of Ginseng Research
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    • v.42 no.1
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    • pp.90-97
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    • 2018
  • Background: Antihyperglycemic effects of Panax ginseng berry have never been explored in humans. The aims of this study were to assess the efficacy and safety of a 12-wk treatment with ginseng berry extract in participants with a fasting glucose level between 100 mg/dL and 140 mg/dL. Methods: This study was a 12-wk, randomized, double-blind, placebo-controlled clinical trial. A total of 72 participants were randomly allocated to two groups of either ginseng berry extract or placebo, and 63 participants completed the study. The parameters related to glucose metabolism were assessed. Results: Although the present study failed to show significant antihyperglycemic effects of ginseng berry extract on the parameters related to blood glucose and lipid metabolism in the total study population, it demonstrated that ginseng berry extract could significantly decrease serum concentration of fasting glucose by 3.7% (p = 0.035), postprandial glucose at 60 min during 75 g oral glucose tolerance test by 10.7% (p = 0.006), and the area under the curve for glucose by 7.7% (p = 0.024) in those with fasting glucose level of 110 mg/dL or higher, while the placebo group did not exhibit a statistically significant decrease. Safety profiles were not different between the two groups. Conclusion: The present study suggests that ginseng berry extract has the potential to improve glucose metabolism in human, especially in those with fasting glucose level of 110 mg/dL or higher. For a more meaningful benefit, further research in people with higher blood glucose levels is required.

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

  • Oh, Seo Young;Kang, Jae Hui;Jang, Tae Soo;Choi, Hee Jeong;Ahn, Taek Won
    • Journal of Haehwa Medicine
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    • v.26 no.1
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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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Randomized, Double-blind, and Placebo-controlled Human Trial to Evaluate the Efficacy and Safety of Allium Fistulosum L. Root Extract on Improvement of Child Height Growth: Study Protocol (총백추출물의 어린이 키 성장에 대한 유효성 및 안전성을 평가하기 위한 무작위배정, 이중눈가림, 위약 대조 인체적용시험: 인체적용시험 프로토콜)

  • Shim, Soo Bo;Ko, Byoung Seob;Ryuk, Jin Ah;Lee, Jung Hwan;Lee, Ho Bong;Ha, Ki Chan;Kim, Yeung Mi;Lee, Hye Lim
    • The Journal of Pediatrics of Korean Medicine
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    • v.35 no.2
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    • pp.11-20
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    • 2021
  • Objectives The purpose of the study is to evaluate the safety of the Allium Fistulosum extract in children and its effectiveness in height growth. Methods This study is randomized, double-blind, placebo-controlled trial. The participants are children between the 3rd and 25th percentiles in height, and between the ages of 5 and 12 years. They are randomly assigned to treatment group or control group. The treatment group will take 5 g (1 g as Allium Fistulosum extract) for 24 weeks, 1 time a day. The control group will take the 5 g (0 g as Allium Fistulosum extract) of placebo for 24 weeks, 1 time a day. The primary outcome is change in height, and the secondary outcomes are growth rate, height standard deviations, Insulin-like growth factor-1 (IGF-1), Insulin-like growth factor binding protein-3 (IGFBP-3), IGF1-1/IGFBP-3 ratio, growth hormone, bone age, osteocalcin, and Z-score for growth. Results This protocol has been approved by the institutional review board (IRB) of Daejeon Korean Medicine Hospital of Daejeon University (IRB No. DJDSKH-20-BM-15), and registered in the Clinical Research Information Service (CRIS) (Registry No. KCT0005981). Conclusions This study will provide clinical information about the effectiveness and safety of Allium Fistulosum extract in children for their growth.

Therapeutic lumbar facet joint nerve blocks in the treatment of chronic low back pain: cost utility analysis based on a randomized controlled trial

  • Manchikanti, Laxmaiah;Pampati, Vidyasagar;Kaye, Alan D.;Hirsch, Joshua A.
    • The Korean Journal of Pain
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    • v.31 no.1
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    • pp.27-38
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    • 2018
  • Background: Related to escalating health care costs and the questionable effectiveness of multiple interventions including lumbar facet joint interventions, cost effectiveness or cost utility analysis has become the cornerstone of evidence-based medicine influencing coverage decisions. Methods: Cost utility of therapeutic lumbar facet joint nerve blocks in managing chronic low back pain was performed utilizing data from a randomized, double-blind, controlled trial with a 2-year follow-up, with direct payment data from 2016. Based on the data from surgical interventions, utilizing the lowest proportion of direct procedural costs of 60%, total cost utility per quality adjusted life year (QALY) was determined by multiplying the derived direct cost at 1.67. Results: Patients in this trial on average received $5.6{\pm}2.6$ procedures over a period of 2 years, with average relief over a period of 2 years of $82.8{\pm}29.6$ weeks with $19{\pm}18.77$ weeks of improvement per procedure. Procedural cost for one-year improvement in quality of life showed USD $2,654.08. Estimated total costs, including indirect costs and drugs with multiplication of direct costs at 1.67, showed a cost of USD $4,432 per QALY. Conclusions: The analysis of therapeutic lumbar facet joint nerve blocks in the treatment of chronic low back pain shows clinical effectiveness and cost utility at USD $2,654.08 for the direct costs of the procedures, and USD $4,432 for the estimated overall cost per one year of QALY, in chronic persistent low back pain non-responsive to conservative management.

Influence of implant-abutment connection structure on peri-implant bone level in a second molar: A 1-year randomized controlled trial

  • Kim, Jin-Cheol;Lee, Jungwon;Kim, Sungtae;Koo, Ki-Tae;Kim, Hae-Young;Yeo, In-Sung Luke
    • The Journal of Advanced Prosthodontics
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    • v.11 no.3
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    • pp.147-154
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    • 2019
  • PURPOSE. This study aimed to evaluate the effect of two different implant-abutment connection structures with identical implant design on peri-implant bone level. MATERIALS AND METHODS. This clinical study was a patient-blind randomized controlled trial following the CONSORT 2010 checklists. This trial was conducted in 24 patients recruited between March 2013 and July 2015. Implants with internal friction connection were compared to those with external hex connection. One implant for each patient was installed, replacing the second molar. Implant-supported crowns were delivered at four months after implant insertion. Standardized periapical radiographs were taken at prosthesis delivery (baseline), and one year after delivery. On the radiographs, distance from implant shoulder to first bone-to-implant contact (DIB) and peri-implant area were measured, which were the primary and secondary outcome, respectively. RESULTS. Eleven external and eleven internal implants were analyzed. Mean changes of DIB from baseline to 1-year postloading were 0.59 (0.95) mm for the external and 0.01 (0.68) mm for the internal connection. Although no significant differences were found between the two groups, medium effect size was found in DIB between the connections (Cohen's d = 0.67). CONCLUSION. Considering the effect size in DIB, this study suggested the possibility of the internal friction connection structure for more effective preservation of marginal bone.

Acupuncture Treatment of Adhesive Capsulitis of the Shoulder: A Randomized Controlled Pilot Trial

  • Kim, Jung-Eun;Kim, Sung-Phil;Kim, Ae-Ran;Park, Hyo-Ju;Kwon, Ojin;Jung, So-Young;Cho, Jung-Hyo;Kim, Joo-Hee;Choi, Sun-Mi
    • Journal of Acupuncture Research
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    • v.35 no.3
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    • pp.120-128
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    • 2018
  • Background: Adhesive capsulitis (AC) is a common condition that includes shoulder pain and limited movement. Despite more than 100 years of AC treatment, the most efficacious treatment remains unclear. The aim of this study was to evaluate the feasibility of a randomized controlled trial (RCT) using acupuncture for AC. Methods: Thirty participants with AC were randomly assigned to acupuncture (A) or sham acupuncture (SA) groups. The participants received 15 acupuncture sessions over 6 weeks, and follow-up occurred for an additional 4 weeks thereafter. The primary clinical outcome was the numeric rating scale (NRS) for shoulder pain 6 weeks from the baseline. Secondary outcomes included range of motion (ROM) in the shoulder, the shoulder pain and disability index (SPADI), the EuroQol-5 dimensions (EQ-5D), the Pittsburgh sleep quality index (PSQI), and the patient global impression of change (PGIC). Results: Thirty participants were enrolled out of 37 screened individuals. Recruitment was conducted between August 2014 until May 2015. A total of 28 participants (93%) completed the 6-week intervention, and 26 participants (87%) completed the study. NRS, ROM, SPADI, EQ-5D, PSQI, and PGIC scores improved in both the experimental group and the sham group after 6 weeks, but the difference between the groups was not statistically significant. Adverse events were reported by 12 participants, although these events were not associated with acupuncture. Conclusion: A future RCT for AC may be feasible with some modifications to the recruitment plan and the secondary outcome measurement methods.

Clinical and microbiological effects of egg yolk antibody against Porphyromonas gingivalis as an adjunct in the treatment of moderate to severe chronic periodontitis: a randomized placebo-controlled clinical trial

  • Xu, Yan;Selerio-Poely, Tshepiso;Ye, Xingru
    • Journal of Periodontal and Implant Science
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    • v.48 no.1
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    • pp.47-59
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    • 2018
  • Purpose: To evaluate the clinical and microbiological effects of the local use of egg yolk immunoglobulin against Porphyromonas gingivalis (anti-P.g. IgY) as an adjunct to scaling and root planing (SRP) in the treatment of moderate to severe chronic periodontitis. Methods: This was a randomized, placebo-controlled, double-blind trial involving 60 systematically healthy patients with moderate to severe chronic periodontitis. Subjects (n=20/group) were randomly assigned to receive SRP combined with subgingival irrigation of anti-P.g. IgY and anti-P.g. IgY mouthwash, subgingival irrigation of 0.2% chlorhexidine and 0.2% chlorhexidine mouthwash, or subgingival irrigation of placebo and placebo mouthwash for 4 weeks. Probing pocket depth, clinical attachment level, bleeding on probing, and the plaque index were evaluated at baseline and at 4 weeks. Subgingival plaque, gingival crevicular fluid, and saliva were simultaneously collected for microbiological analysis. Results: Our results showed that anti-P.g. IgY mouthwash was as effective as chlorhexidine at improving clinical parameters over a 4-week period. All the groups showed a significant reduction in levels of P.g. at 4 weeks. No significant difference was observed in the test group when compared to placebo regarding the reduction in the levels of P.g. Anti-P.g. IgY significantly suppressed the numbers of red complex bacteria (RCB) in subgingival plaque and saliva in comparison with placebo. No adverse effects were reported in any of the subjects. Conclusions: Within the limitations of the study, the present investigation showed that passive immunization with anti-P.g. IgY may prove to be effective in the treatment of chronic periodontitis due to its ability to improve clinical parameters and to reduce RCB. No significant differences were found between the anti-P.g. IgY and placebo groups in the reduction of P.g.

A Literature Review of Clinical Trials on Alternative Medicine (대체의학 임상실험 현황에 대한 문헌고찰)

  • Cho, Hyun;Yoo, Jin-Yeong;Park, Soo-Hee
    • Journal of the Korea Academia-Industrial cooperation Society
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    • v.11 no.11
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    • pp.4395-4403
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    • 2010
  • The aim of this study is to know about condition of alternative medicine. Methods which An literature search in Pubmed January 2000 to March, 2010 was performed. RCT(Randomized Controlled Trial), CCT(Controled Clinical Trials), and OD(efficacy studies with either a controlled or an Other than controlled Design) were included. PubMed databases were searched using key terms relating to alternative medicine. 19 clinical trials were included among 682 studies searched. RCT was 44%, CCT was 16% and OD was 40% in the review. In the all of included studies, the acupuncture and the massage was the biggest part. The using rate was 20% of pain control about Disease of the Musculoskeletal system and Connective tissue, 15% of Certain infectious and parasitic diseases, and 15% of Neoplasms. There was lack of evidence that alternative medicine was effective for progress. Future well-designed clinical trials is needed.