• Title/Summary/Keyword: Randomized clinical trial

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Recent Clinical Research on Effect of Acupuncture for Rhinitis - Within RCT, Review - (비염의 침 치료에 대한 최근 임상 연구 동향 - RCT, Review 중심으로 -)

  • Shin, Ji-Hye;Lee, Jang-Cheon;Kim, Ki-Bong
    • The Journal of Pediatrics of Korean Medicine
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    • v.26 no.1
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    • pp.46-59
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    • 2012
  • Objectives The purpose of this study is to investigate recent clinical studies on effect of acupuncture for rhinitis in other countries. We have analyzed the studies on effect of acupuncture for rhinitis within randomized controlled trial(RCT), reviewed for 11 years (from 2001 to 2011). Methods The search database includes PubMed. To narrow the search, the following key search terms were used: 'rhinitis, acupuncture'. The search was limited to the publication date from 2001 to 2011. Results Total 20 studies were selected: RCT(13), review(5), case report(1), and cost effectiveness study(1). In RCT, 9 studies used acupuncture only, and 8 studies of them have revealed that acupuncture is effective on rhinitis. In review, 3 studies are systematic review, 2 studies are no systematic review. Among systematic review, 2 studies have revealed partial effectiveness of acupuncture for rhinitis, but they suggested the necessity of further studies. Conclusions Domestic studies on effect of acupuncture for rhinitis are necessary. For more accurate results, controlled, large scale and well designed studies are recommended.

Recent Clinical Research Trends on Acupuncture Treatment of Meniere's Disease (메니에르 병의 침 치료에 관한 최근 임상 연구 동향)

  • Lee, Kyou-Young;Hong, Chul-Hee
    • The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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    • v.31 no.3
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    • pp.26-38
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    • 2018
  • Objectives : The purpose of this study is to investigate the possibility of applying acupuncture to the treatment of meniere's disease, which has no definite treatment methods, by analyzing the latest clinical researches about acupuncture treatment of meniere's disease. Methods : A case study and Randomized Controlled Trial (RCT) related to the acupuncture treatment of meniere's disease were searched using domestic and international thesis search engines including OASIS, CNKI, J-STAGE, PubMed. This study include acupuncture treatment and acupuncture combined with other treatments such as herbal medicine. The search was limitied to the publication date from 2000 to 2018 with free full text. Results : 17 cases were selected. There were 7 case studies in Korea, 5 case studies in China, and 5 RCT papers in China. All 12 cases reported improvement in meniere's disease and all RCT studies showed significantly higher treatment effects in the experimental group than in the control group. Conclusions : Acupuncture treatment showed significant effects for meniere's disease when applied alone or in combination with other treatments. In the future, various systematic studies should be conducted only for acupuncture treatment.

Comparing the Therapeutic Effects of Aloe vera and Olive Oil Combination Cream versus Topical Betamethasone for Atopic Dermatitis: A Randomized Double-blind Clinical Trial

  • Panahi, Yunes;Rastgar, Nassim;Zamani, Ali;Sahebkar, Amirhossein
    • Journal of Pharmacopuncture
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    • v.23 no.3
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    • pp.173-178
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    • 2020
  • Objectives: Atopic dermatitis (AD) is a prevalent and chronic, pruritic inflammatory skin condition that can influence all age groups. AD is associated with a poor health-related quality of life. This randomized clinical trial was performed to compare the effectiveness of Olivederma (combination of aloe vera and virgin olive oil) or betamethasone regarding disease severity, quality of life, serum IgE and eosinophil count. Methods: Thirty-six AD patients were randomly allocated to topical Olivederma or betamethasone, and were followed for 6 weeks. Results: Total SCORAD severity scores showed significant decrease in both groups, while it was more prominent in Olivederma group (64.5% improvement in Olivederma vs. 13.5% improvement in Betamethasone, p-value < 0.001). Quality of life (DLQI questionnaire) of AD patients was significantly improved after 6 weeks treatment with Betamethasone (22.3%, p < 0.001) and Olivederma (60.7%, p-value < 0.001). Olivederma group showed a significantly lower DLQI score in comparison with Betamethasone treated patients after 6 weeks of therapy (p < 0.001). Improvements in eosinophil count and serum IgE was observed. Conclusion: In summary, this study shows that Olivederma is superior to topical Betamethasone after 6 weeks of therapy with regard to disease severity, quality of life and eosinophil count.

Type of tooth movement during en masse retraction of the maxillary anterior teeth using labial versus lingual biocreative therapy in adults: A randomized clinical trial

  • Sadek, Mais M.;Sabet, Noha E.;Hassan, Islam T.
    • The korean journal of orthodontics
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    • v.49 no.6
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    • pp.381-392
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    • 2019
  • Objective: The objective of this two-arm parallel trial was to compare the type of tooth movement during en masse retraction of the maxillary anterior teeth using labial versus lingual biocreative therapy. Methods: Twenty-eight subjects were randomized in a 1 : 1 ratio to either the labial or lingual group. En masse anterior retraction was performed using labial biocreative therapy in group A and lingual biocreative therapy in group B. Cone beam computed tomography scans were taken before and after retraction and the primary outcome was the type of tooth movement during anterior retraction. Data were analyzed using paired t-tests for comparisons within each group and independent-sample t-test for comparison of the mean treatment changes between the two groups. Results: Significant differences were found between the two groups in relation to the type of tooth movement (labiolingual inclination of the central incisor; mean difference, $5.85{\pm}1.85^{\circ}$). The canine showed significant distal tipping in the lingual group (mean difference, $6.98{\pm}1.25^{\circ}$). The canine was significantly more intruded in the lingual group (mean difference, $1.67{\pm}0.49mm$). Good anchorage control and significant soft tissue changes occurred in both groups. No serious adverse effects were detected. Conclusions: With a 10-mm retraction hook, the labial biocreative technique with the reverse curve overlay provided anterior retraction with good torque control, while in the lingual group, anterior retraction occurred with controlled tipping movement with significant distal tipping and intrusion of the canine (trial registration: The trial was registered at ClinicalTrials.gov [NCT03239275]).

Safety and antifatigue effect of Korean Red Ginseng capsule: A randomized, double-blind and placebo-controlled clinical trial

  • Yang, Yi;Wang, Hong;Zhang, Ming;Shi, Mengxue;Yang, Cailing;Ni, Qiang;Wang, Qi;Li, Jing;Wang, Xuemei;Zhang, Chen;Li, Zhi
    • 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.

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.