• Title/Summary/Keyword: randomized clinical controlled trial

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Administration of Yijung-tang, Pyeongwi-san, and Shihosogan-tang for Standardization of Korean Medicine Pattern Identification for Functional Dyspepsia: A Study Protocol of a Randomized, Assessor-blind, 3-Arm, Parallel, Open-label, Multicenter Clinical Trial (기능성 소화불량 한의 변증 표준화를 위한 이중탕, 평위산 및 시호소간탕 투여 : 무작위 배정, 평가자 눈가림, 3군 비교, 평행 설계, 공개, 다기관 임상시험 프로토콜)

  • Boram Lee;Min-Jin Cho;Young-Eun Choi;Ojin Kwon;Mi Young Lim;Seok-Jae Ko;So-yeon Kim;Yongjoo Kim;Donghyun Nam;Dong-Jun Choi;Jun-Hwan Lee;Jae-Woo Park;Hojun Kim
    • The Journal of Internal Korean Medicine
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    • v.43 no.6
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    • pp.1105-1121
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    • 2022
  • Objectives: The purpose of this study is to explore the effectiveness and safety of frequently used clinical herbal medicines (Yijung-tang [Lizhong-tang, LJT], Pyeongwi-san [Pingwei-san, PWS], and Shihosogan-tang [Chaihu Shugan-tang, SST]) in patients with functional dyspepsia (FD) when administered according to herbal medicine and Korean medicine pattern identification. The results of this study will be used to standardize the diagnostic instrument used in Korean medicine and to investigate biomarkers of Korean medicine pattern identification. Methods: This study will be a randomized, assessor-blind, 3-arm, parallel, open-label, multi-center clinical trial. A total of 300 FD participants will be recruited from 3 Korean medical hospitals and assigned to the LJT (n=100), PWS (n=100), and SST (n=100) groups according to FD pattern identification. The patients will take the medication for 8 weeks, 3 times a day, before or between meals. The primary outcome will be total dyspepsia symptom (TDS) and the secondary outcomes will be adequate relief (AR) for dyspepsia, overall treatment effect (OTE), visual analogue scale (VAS), functional dyspepsia-related quality of life (FD-QoL), gastrointestinal symptom score (GIS), and pattern identification questionnaires. For the exploratory outcomes, we will analyze blood and fecal metabolome profiles, microbiota from fecal and saliva samples, single nucleotide polymorphism (SNP), and results of Korean medicine diagnosis device measurements (heart rate variability, and tongue, pulse, and abdominal diagnosis). Conclusions: The results of this study will prove objectivity for Korean medicine pattern identifications, and the effectiveness and safety of herbal medicines for the population with FD.

The effect of treadmill gait training with patellar taping on gait abilities in chronic stroke patients

  • Shin, Jin;Chung, Yijung
    • Physical Therapy Rehabilitation Science
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    • v.4 no.2
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    • pp.94-102
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    • 2015
  • Objective: The purpose of this study is to investigate the effect of treadmill gait training with patellar taping on gait abilities in chronic stroke patients. Design: Randomized controlled trial. Methods: Thirty chronic stroke patients who have been diagnosed at least six months or before were recruited in Gyeongin Rehabilitation Center Hospital, located in Incheon. Patients who were enrolled in this study were randomized to experimental group (n=15) or control group (n=15). Treadmill with patella taping training group patients were applied with patellar taping when they were being trained on a treadmill. Control group patients were being trained on a treadmill without any kind of taping. Gait parameters were measured with a GAITRite$^{(R)}$ system which evaluated gait performances. Gait trainings were done for 30 min/day, 5 days/week, for 4 weeks. Results: After treadmill training, treadmill with patella taping training group showed a significant improvement in gait abilities, including velocity, cadence, paretic and non-paretic step length, and double support period (p<0.05). However, in general treadmill group, there were no significant differences in gait parameters except velocity and cadence. There was a significant difference in gait performance in the experimental group compared with the control group, except for the gait symmetry ratio (p<0.05). Conclusions: According to this result of this study, it seems that application of patellar taping in treadmill gait training for chronic stroke patients significantly improved gait abilities of these patients. Also, we can conclude that patella taping is thought to be useful in real clinical settings where there are many chronic patients who are in need of improvement in their gait abilities.

Comparison of Superficial and Deep Acupuncture in the Treatment of Ankle sprain : A Randomized Controlled Trial-Pilot study (무작위 대조 시험을 통한 족관절 염좌의 자침 중 심자와 천자의 비교 연구-준비 조사)

  • Park, Jun-sung;Kim, Woo-young;Baek, Seung-tae;Lee, Seung-deok;Kim, Kap-sung
    • Journal of Acupuncture Research
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    • v.21 no.5
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    • pp.137-147
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    • 2004
  • Objective : The aim of the study was to compare the therapeutic effect of the superficial and in-depth insertion of acupuncture needles in the treatment of patients with ankle sprain. Design : A prospective randomized single-blind study of superficial and deep acupuncture was conducted. Setting : The study was conducted in the Kang-nam Oriental Hosp. of Dong-Guk University. Patients: The study comprised 14 patients with ankle sprain who were divided into two groups (A and B). Intervention : In group A, the needle was introduced in the skin at a depth of 2 mm, whereas in group B the needle was placed deeply into muscular tissue or the articular capsule at a depth more than 1.5 Cm The treatment was planned for a duration of 1 week, 3 times. Outcome Measures : The intensity of pain was evaluated with the Ankle grade pain chart(AGPC) before and after treatment and at the 1-week follow-up examination. The AGPC includes Swelling, Tenderness, Exudation, Bruise, Medial/Lateral. stability test, Anterior drawer test, Squeeze test, Bearing weight, Pressure Algometer, Walking state and VAS. Results : Although at the end of the treatment there was no evidence of significant statistical differences between the two different groups, Pain reduction(VAS) was greater in the group treated with deep acupuncture. A statistical difference existed between the two groups at the 1 week follow up, with a better result in the deeply stimulated group in VAS. Conclusion : Clinical results show that deep stimulation has a better analgesic effect when compared with superficial stimulation in pain reduction(VAS, Visual analogic scale).

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A Randomized Controlled Clinical Trial of Topical Herbal Gel Treatment for Chronic Shoulder Pain (만성 어깨 통증의 한약 추출 외용 젤 치료에 대한 임상연구)

  • Jo, Su Jeong;Choi, Young Doo;Jang, Jin Taek;Kim, Kap Sung;Lee, Seung Deok
    • Journal of Acupuncture Research
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    • v.31 no.4
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    • pp.1-9
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    • 2014
  • Objectives : The aim of this study is to evaluate the efficacy of a topical herbal gel application for the treatment of chronic shoulder pain. Methods : We compared the effects of Dapureo gel, which contains several herbal medicines known to improve shoulder pain, with those of placebo gel by double-blind method. 30 participants were randomized - 15 were assigned to treatment group and the other 15 were assigned to control group. Either Dapureo gel(treatment group) or placebo gel(control group) was applied topically by themselves, once a day for 2 weeks. Primary outcome was daily visual analogue scale(VAS) changes for shoulder pain which was self-reported for 2 weeks. Secondary outcome was the difference in the total shoulder pain and disability index(SPADI) which was measured at a baseline and 2 weeks after the treatment. Results : Primary outcome: Subjects of treatment group showed statistically significant improvement in VAS compared to control subjects continuously from the second day(p <0.05) to the fifteenth day(p <0.001). The treatment group showed 31% of pain reduction on the fifteenth day, while the control group showed only 7%. Secondary outcome: In terms of SPADI changes, the treatment group showed improvement compared to the control group(p <0.01). Conclusions : These results suggest that the topical herbal gel treatment used in this study is effective in improving chronic shoulder 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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    • v.11 no.4
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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.

The immediate effects of patellar taping on balance and gait ability in individuals with chronic stroke

  • Shin, Jin;Mun, Mee-Hyang;Chung, Yijung
    • Physical Therapy Rehabilitation Science
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    • v.3 no.2
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    • pp.125-133
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    • 2014
  • Objective: The aim of this study is to investigate the effect of patellar taping on balance and gait abilities in chronic stroke patients. Design: Randomized placebo-controlled trial. Methods: Thirty chronic stroke patients who have been diagnosed at least six months or before were recruited from R hospital. These study subjects were randomized to the experimental group (n=15) or placebo group (n=15). In the experimental group, patellar taping was applied while for the placebo group, placebo taping was applied. The Balance System SD was used for measuring dynamic standing balance in these two groups. In addition, the GAITRite (CIR System Inc.) system was utilized for calculating gait performance in these patients. Results: After application of taping, the patellar taping group showed a significant decrease in dynamic standing balance in their sway area (p<0.05). However, in the placebo group, there was no significant difference in dynamic standing balance ability and gait ability before and after application of taping. Comparison of the patellar taping group and placebo group showed significant differences in dynamic standing balance ability and gait performance (p<0.05). Conclusions: From the results of this study, it appears that application of patellar taping in chronic stroke patients significantly improved dynamic standing balance ability and gait ability in these patients. Based on these results, patellar taping is thought to be useful in real clinical settings where there are many chronic patients who are in need of improvement in their balance and gait ability.

Effects of garlic intake on cancer: a systematic review of randomized clinical trials and cohort studies

  • Lee, Jounghee;Zhao, Naisi;Fu, Zhuxuan;Choi, Jihee;Lee, Hae-Jeung;Chung, Mei
    • Nutrition Research and Practice
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    • v.15 no.6
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    • pp.773-788
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    • 2021
  • BACKGROUND/OBJECTIVES: Due to the rapid increase of global cancer incidence and mortality and a high level of interest in cancer prevention, a systematic review of garlic intake and cancer risk is needed. SUBJECTS/METHODS: We implemented a systematic review to examine the effects of varying levels of garlic intake on cancer. We conducted comprehensive literature searches in three electronic databases (MEDLINE, Embase, and Web of Science) for studies published between database inception and July or September of 2018. Two investigators independently screened abstracts and full-texts, extracted data, and assessed risk of bias (RoB). A total of one medium-quality randomized controlled trial (RCT) and 13 cohort studies graded as high RoB were included. RESULTS: The 1-year follow-up results from a RCT showed that a significant decrease in the number and size of colorectal adenomas among participants with colorectal adenomas who received high-dose aged garlic extract (AGE) compared with those who received low-dose AGE (P < 0.05). The results of prospective observational studies provided inconsistent associations of colorectal cancer risk with garlic supplements and garlic intake as food. CONCLUSIONS: In summary, the AGE was effective in reducing the number and magnitude of colorectal adenomas in one RCT, but there were inconsistent associations between garlic intake and colorectal cancer in cohort studies. Therefore, we could not draw a firm conclusion regarding the effects of garlic on cancer, because the current strength of evidence is inadequate due to a lack of number of high-quality RCTs.

Effects of a low-FODMAP enteral formula on diarrhea on patients in the intensive care unit

  • Bae, Eunjoo;Kim, Jiyoon;Jang, Jinyoung;Kim, Junghyun;Kim, Suyeon;Chang, Youngeun;KIM, MI YEON;Jeon, Mira;Kang, Seongsuk;Lee, Jung Keun;Kim, Tae Gon
    • Nutrition Research and Practice
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    • v.15 no.6
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    • pp.703-714
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    • 2021
  • BACKGROUND/OBJECTIVES: A dietary restriction on the intake of fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (FODMAPs) has been reported to be effective in the treatment of gastrointestinal (GI) tract complications. Enteral nutrition (EN) is widely used for patients who cannot obtain their nutritional requirements orally, but many studies have reported EN complications, especially diarrhea, in up to 50% of patients. SUBJECTS/METHODS: We performed a single-center, non-randomized, controlled trial to determine the effects of a low-FODMAP enteral formula on GI complications in patients in intensive care units (ICUs). Patients in the ICU who needed EN (n = 66) were alternately assigned to the low-FODMAP group (n = 33) or the high-FODMAP group (n = 33). RESULTS: Anthropometric and biochemical parameters were measured, and stool assessment was performed using King's Stool Chart. We excluded patients who received laxatives, GI motility agents, proton pump inhibitors, antifungal agents, and antibiotics other than β-lactams. There were no differences in GI symptoms during 7 days of intervention, including bowel sound, abdominal distension, and vomiting between the 2 groups. However, diarrhea was more frequent in the high-FODMAP group (7/33 patients) than the low-FODMAP group (1/33 patients) (P = 0.044). CONCLUSIONS: Our results suggest that a low-FODMAP enteral formula may be a practical therapeutic approach for patients who exhibit enteral formula complications. Our study warrants further randomized clinical trials and multicenter trials.

Clinical efficacy of 0.75% ropivacaine vs. 2% lignocaine hydrochloride with adrenaline (1:80,000) in patients undergoing removal of bilateral maxillary third molars: a randomized controlled trial

  • Kakade, Aniket Narayan;Joshi, Sanjay S.;Naik, Charudatta Shridhar;Mhatre, Bhupendra Vilas;Ansari, Arsalan
    • Journal of Dental Anesthesia and Pain Medicine
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    • v.21 no.5
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    • pp.451-459
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    • 2021
  • Background: Lignocaine with adrenaline is routinely used as a local anesthetic for dental procedures. Adrenaline was added to increase the duration of anesthesia. However, epinephrine containing a local anesthetic solution is not recommended in conditions such as advanced cardiovascular diseases and hyperthyroidism. Recently, ropivacaine has gained popularity as a long-acting anesthetic with superior outcomes. The goal of this study was to assess and compare the effectiveness of 0.75% ropivacaine alone and 2% lignocaine with adrenaline (1:80,000) in the removal of bilateral maxillary wisdom teeth using the posterior superior alveolar nerve block technique. Methods: This was a single-blind, randomized, split-mouth, prospective study assessing 15 systemically sound outpatients who needed bilateral removal of maxillary third molars. We randomly allocated the sides and sequences of ropivacaine and lignocaine with adrenaline administration. We evaluated the efficacy of both anesthetics with regard to the onset of anesthesia, intensity of pain, variation in heart rate, and blood pressure. Results: The onset of anesthesia was faster with lignocaine (138 s) than with ropivacaine (168 s), with insignificant differences (p = 0.001). There was no need for additional local anesthetics in the ropivacaine group, while in the lignocaine with adrenaline group, 2 (13.3%) patients required additional anesthesia. Adequate intraoperative anesthesia was provided by ropivacaine and lignocaine solutions. No significant difference was observed in the perioperative variation in blood pressure and heart rate. Conclusion: Ropivacaine (0.75%) is a safe and an adrenaline-free local anesthetic option for posterior superior alveolar nerve block, which provides adequate intraoperative anesthesia and a stable hemodynamic profile for the removal of the maxillary third molar.

Chemical cleansing as an adjunct to subgingival instrumentation with ultrasonic and hand devices in deep periodontal pockets: a randomized controlled study

  • Zafar, Fahad;Romano, Federica;Citterio, Filippo;Ferrarotti, Francesco;Dellavia, Claudia;Chang, Moontaek;Aimetti, Mario
    • Journal of Periodontal and Implant Science
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    • v.51 no.4
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    • pp.276-284
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    • 2021
  • Purpose: The aim of this randomized clinical trial was to assess whether chemical cleansing using a sulfonic/sulfuric acid gel solution (HBX) as an adjunct to scaling and root planing (SRP) resulted in a decrease in residual plaque and calculus in deep periodontal pockets compared to SRP alone. Methods: Fifty-six patients with 56 hopeless posterior teeth, scheduled for extraction due to severe periodontitis, were enrolled in this study. Each tooth was randomly assigned to 1 of the 2 experimental procedures. The test teeth were subjected to the irrigation of the subgingival area with HBX for 2 minutes, followed by SRP with hand and ultrasonic instruments for 14 minutes, and then extracted. The control teeth received only mechanical instrumentation before extraction. Residual biofilm was evaluated on photographs and measured as total area and percentage of root surface covered by remaining plaque (RP) or calculus (RC) after treatment. Results: The initial pocket depth (PD) and total subgingival root surface area were similar between the 2 treatment groups. After treatment, the total subgingival root area covered by RP and RC was statistically significantly larger (P<0.001) in the control group than in the test group. The test teeth showed a lower percentage of RP, but a higher percentage of RC than the control teeth (both P<0.001). Complete calculus removal was achieved in 42% of the control teeth surfaces and in 25% of the test teeth surfaces for a PD of 4 mm. Conclusions: The additional chemical cleansing with HBX resulted in a statistically significant improvement in bacterial plaque removal during SRP of deep pockets, but it was not effective in reducing calculus deposits.