• Title/Summary/Keyword: randomized clinical trial

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Effects of Non-Contact Complex Exercise Program on the Older over 65 Years of Age on Muscle Strength, Falling Efficacy and Balance Ability

  • Sam Ho Park;Youn Jung Oh;Myung Mo Lee
    • Physical Therapy Rehabilitation Science
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    • v.12 no.2
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    • pp.167-176
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    • 2023
  • Objective: The purpose of this study was to investigate the effects of anon-contact complex exercise program on muscle strength, fall efficacy, quality of life, and balance ability in older over 65 years of age. Design: A randomized controlled trial Methods: A total of 37 people in older over 65 years of age participated in the study. Random program was conducted and assigned to the experimental group (n=19) and the control group (n=18). Both groups performed the older people welfare center program. In addition, in the experimental group, a non-contact complex exercise program for muscle and balance exercise was performed. All interventions were performed 2 times a week, for a total of 6 weeks. chair stand test (CST), fall efficacy scale (FES), Euro quality of life 5 dimension (EQ-5D), Berg balance scale (BBS), timed up and go test (TUG), Fullerton advanced balance scale (FAB) were measured before and after the intervention to compare their effectiveness. Results: Both groups showed significant differences in CST, FES, EQ-5D, BBS, and TUG before and after intervention (p<0.05). FAB showed significant differences before and after intervention in all items except for FAB 8 and 9 items in the experimental group. In addition, the experimental group showed significant differences in CST, FES, BBS, TUG, FAB (except 1, 7, 8, 9) compared to the control group (p<0.05). Conclusions: The non-contact complex exercise program is an effective intervention method that has clinical significance in improving muscle strength, fall efficacy and static and dynamic balance abilities for the older over 65 years of age.

The Effect of Posteroanterior Joint Mobilization Applied to The 3rd Lumbar Vertebra Movement of Adjacent Segmental in Healthy Individuals

  • Kang-O Oh;Sang-Yeol Lee
    • Physical Therapy Rehabilitation Science
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    • v.12 no.3
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    • pp.240-250
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    • 2023
  • Objective: The purpose of this study was to characterize the movement of adjacent segments that occurred when posteroanterior joint mobilization was applied to the 3rd lumbar and thereby to provide basic clinical data. Design: Randomized controlled trial design. Methods: While the subjects were receiving posteroanterior joint mobilization of the 3rd lumbar vertebra, LD (lumbar displacement), LID (lumbar intervertebral distance), LIA (lumbar intervertebral angle), and LLA (lumbar lordosis angle) were measured using X-ray, and the data were then analyzed. Changes before and after posteroanterior joint mobilization were analyzed using a paired-sample t-test, and a one-way ANOVA of variance was performed to determine the difference between segmental movements. In addition, Pearson's correlation analysis was performed to determine the correlation between segmental movements. Results: The results revealed that there was a significant change in LD before and after the application of joint mobilization of the 3rd lumbar in all lumbar vertebrae (p<0.000), among which the 2nd lumbar vertebra, an adjacent segment, showed the most significant change. A significant change in LIA angle was observed in all segments (p<0.000), with the most significant change observed between the 2nd and 3rd lumbar vertebrae. There was a significant change in LLA before and after the application of posteroanterior joint mobilization (p<0.000). The correlation analysis showed a high correlation between displacement of the 3rd lumbar vertebra and displacement of all the other lumbar vertebrae. Conclusions: The presence of kinematic movements of the lumbar vertebrae when segmental movements were generated through the application of posteroanterior joint mobilization of the 3rd lumbar vertebra.

Efficacy of kaleidoscope, virtual reality, and video games to alleviate dental anxiety during local anesthesia in children: a randomized clinical trial

  • Karthik Anchala;Voppathotty Tirumala;Kanamarlapudi Venkata Saikiran;Niharika Reddy Elicherla;Shaik Rahul;Sivakumar Nuvvula
    • Journal of Dental Anesthesia and Pain Medicine
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    • v.24 no.3
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    • pp.195-204
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    • 2024
  • Background: Distraction is a technique used to divert a patient's attention from unpleasant procedures. This study aimed to evaluate the effectiveness of kaleidoscopy, virtual reality, and video games in reducing anxiety and pain during invasive dental procedures in children. Methods: Sixty-six children aged 6 to 9 years were randomly assigned to three groups during local anesthesia administration: Group 1 (kaleidoscope), Group 2 (virtual reality), and Group 3 (mobile video games). The anxiety of the children was evaluated using physiological measures (heart rate) at three different time points: before, during, and after the procedure. The Raghavendra, Madhuri, and Sujata pictorial scale was used as a subjective measure before and after the procedure. Subjective measures of pain were assessed using the Wong-Baker Faces Pain Scale. The data were statistically analyzed using the Kruskal-Wallis and Wilcoxon signed-rank tests. Results: In the intergroup comparison, there were no statistically significant differences in the physiological measures of anxiety scores between the three groups before, during, and after distraction. Raghavendra, Madhuri, and Sujata pictorial scale scores were assessed before and after distraction, but no statistically significant differences were observed. Among the three groups, the children in Group 2 showed a significant reduction in pain scores. Conclusion: Compared with kaleidoscopes and video games, virtual reality is a promising distraction technique for reducing dental fear, anxiety, and pain during local anesthesia administration in children.

A comparative evaluation of peppermint oil and lignocaine spray as topical anesthetic agents prior to local anesthesia in children: a randomized clinical trial

  • Harika Petluru;SVSG Nirmala;Sivakumar Nuvvula
    • Journal of Dental Anesthesia and Pain Medicine
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    • v.24 no.2
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    • pp.119-128
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    • 2024
  • Background: In pediatric dentistry, fear and anxiety are common among children. Local anesthetics (LA) are widely used to control pain and reduce discomfort in children during dental treatment. Topical anesthetics play a vital role in reducing pain and the unpleasant sensation of a needle puncture in children. Peppermint oil has been extensively used for various diseases. However, its anesthetic properties remain unknown. Peppermint oil, used in mouthwashes, toothpastes, and other topical preparations has analgesic, anesthetic, and antiseptic properties. This study aimed to compare and evaluate pain perception following the topical application of peppermint oil versus lignocaine spray before an intraoral injection in children, aged 8-13 years. Method: Fifty-two children, aged between 8-13 years, who required local anesthesia for dental treatment were divided into two groups of 26 each by simple random sampling (Group 1: 0.2% peppermint oil and Group 2: lignocaine spray). In both groups, physiological measurements (e.g., heart rate) were recorded using pulse oximetry before, during, and after the procedure. Objective pain measurement (Sound Eye Motor (SEM) scale) during administration and subjective measuremeant (Wong-Baker Faces Pain Rating Scale (WBFPRS)) after LA administration were recorded. This was followed by the required treatment of the child. Physiological parameters were compared between the two groups using an independent t-test for intergroup assessment and a paired t-test and repeated-measures ANOVA for intragroup comparisons. The Mann-Whitney U test was used to analyze the pain scores. Results: Intragroup mean heart rates, before, during, and after treatment were statistically significantly different (P < 0.05). However, the intergroup mean pulse rates did not differ significantly between the two groups. The mean WBFPS score in the lignocaine spray group was 4.133 ± 2.06 was statistically different from that of the peppermint oil group (0.933 ± 1.03; P < 0.001*). The mean SEM score was significantly lower in the peppermint oil group than that in the lignocaine spray group (P = 0.006). No negative effects were observed in this study. Conclusion: 0.2% peppermint oil was effective in reducing pain perception.

The nasoalveolar molding technique versus DynaCleft nasal elevator application in infants with unilateral cleft lip and palate

  • Abdallah Bahaa;Nada El-Bagoury;Noura Khaled;Sameera Mohamed;Ahmed Bahaa;Ahmed Mohamed Ibrahim;Khaled Mohamad Taha;Mohsena Ahmad Abdarrazik
    • Archives of Craniofacial Surgery
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    • v.25 no.3
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    • pp.123-132
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    • 2024
  • Background: The introduction of presurgical nasoalveolar molding represented a significant departure from traditional molding methods. Developed by Grayson and colleagues in 1993, this technique combines an intraoral molding device with a nasal molding stent. This study aimed to compare the Grayson nasoalveolar molding appliance versus DynaCleft appliance as two methods of presurgical nasoalveolar molding. Methods: A single-blinded, randomized, parallel-arm clinical trial was conducted. Sixteen infants with complete unilateral cleft lip and palate were enrolled and divided into two groups of eight. Group 1 was treated with a modified Grayson nasoalveolar molding appliance that included a nasal stent, while group 2 was treated with DynaCleft elastic adhesive tape and an external nasal elevator. Standardized digital photographs of each infant were taken at baseline and post-treatment using a professional camera. Nine extraoral anthropometric measurements were obtained from each image using image measurement software. Results: The modified Grayson nasoalveolar appliance demonstrated a more significant improvement compared to DynaCleft in terms of alar length projection (on both sides), columella angle, and nasal tip projection. Symmetry ratios also showed enhancement, with significant improvements observed in nasal width, nasal basal width, and alar length projection (p< 0.05). Conclusion: Both the modified Grayson nasoalveolar appliance and DynaCleft appear to be effective presurgical infant orthopedics treatment options, demonstrating improvements in nasolabial aesthetics. The modified Grayson appliance, equipped with a nasal stent, improved nasal symmetry more effectively than DynaCleft, resulting in a straighter columella and a more medially positioned nasal tip.

The Effect of the Combination of Ginseng, Tribulus Terrestris, and L-arginine on the Sexual Performance of Men with Erectile Dysfunction: a randomized, double-blind, parallel, and placebo-controlled clinical trial

  • Reza Tahvilian;Mohammad Amin Golesorkhi;Farajollah Parhoudeh;Fatemeh Heydarpour;Hossein Hosseini;Hojjat Baghshahi;Hossein Akbari;Mohammad Reza Memarzadeh;Mehdi Mehran;Hosna Bagheri
    • Journal of Pharmacopuncture
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    • v.27 no.2
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    • pp.82-90
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    • 2024
  • Objectives: Nitric oxide is the most important mediator of penile erection after the onset of sexual excitement. It activates cyclic guanosine monophosphate (cGMP), increasing penile blood flow. Most pharmaceutical medications prevent enzyme phosphodiesterase type 5 (PDE-5) from breaking down cGMP, thus keeping its level high. However, due to the adverse effects of pharmacological therapies, herbal drugs that improve sexual function have gained attention recently. This study aimed to investigate the combined effects of ginseng, Tribulus terrestris, and L-arginine amino acid on the sexual performance of individuals with erectile dysfunction (ED) using the 5-item version of the International Index of Erectile Function (IIEF-5) questionnaire. Methods: Over three months, 98 men with erectile dysfunction were randomly assigned to receive either 500 mg of herbal supplements or placebo pills. Each herbal tablet contained 100 mg of protodioscin, 35 mg of ginsenosides, and 250 mg of L-arginine. Results: The results showed that the changes in the average scores of ILEF-5 within each group before and after the intervention indicated that all parameters related to the improvement of sexual function in patients with erectile dysfunction improved in the herbal treatment group (p < 0.001). The herbal group significantly improved IIEF-5 scores in nondiabetics (p < 0.05). However, there was no significant difference in the changes of IIEF-5 scores between the two intervention and control groups in diabetic patients. Conclusion: In conclusion, ginseng, Tribulus terrestris, and L-arginine have properties that increase energy and strengthen sexual function, making them suitable for patients with sexual disorders.

Bioequivalence of SCD Zaltoprofen Tablet to Soleton® Tablet (Zaltoprofen 80 mg) (솔레톤 정(잘토프로펜 80 mg)에 대한 삼천당잘토프로펜 정의 생물학적동등성)

  • Kang, Hyun-Ah;Park, Sun-Ae;Kim, Dong-Ho;Kim, Hwan-Ho;Yun, Hwa;Kim, Kyng-Ran;Yoo, Hee-Doo;Park, Eun-Ja;Cho, Hye-Young;Lee, Yong-Bok
    • Journal of Pharmaceutical Investigation
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    • v.36 no.3
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    • pp.209-215
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    • 2006
  • Zaltoprofen, (2-(10,11-dihydro-10-oxodibenzo[b,f]thiepin-2-yl)propionic acid) is an NSAID with powerful anti-inflammatory effects as well as an analgesic action on inflammatory pain. The purpose of the present study was to evaluate the bioequivalence of two zaltoprofen tablets, $Soleton^{\circledR}$ (CJ Corp.) and SCD Zaltoprofen (Samchundang Pharmaceutical Co., Ltd.), according to the guidelines of the Korea Food and Drug Administration (KFDA). The release of zaltoprofen from the two zatoprofen formulations in vitro was tested using KP Vlll Apparatus ll method with various dissolution media. Twenty six healthy male subjects, $23.2{\pm}2.26$ years in age and$64.7{\pm}8.08$ kg in body weight, were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After a single tablet containing 80 mg as zaltoprofen was orally administered, blood samples were taken at predetermined time intervals and the concentrations of zaltoprofen in serum were determined using HPLC with UV detector. The dissolution profiles of two formulations were similar in all tested dissolution media. The pharmacokinetic parameters such as $AUC_t$, $C_{max}$ and $T_{max}$ were calculated, and ANOVA test was utilized for the statistical analysis of the parameters using logarithmically transformed $AUC_t$, $C_{max}$ and untransformed $T_{max}$. The results showed that the differences between two formulations based on the reference drug, $Soleton^{\circledR}$ were 6.33, 5.91 and 17.7% for $AUC_t$, $C_{max}$ and untransformed $T_{max}$, respectively. There were no sequence effects between two formulations in these parameters. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of log 0.8 to log 1.25 (e.g.,log $1.01{\sim}1og\;1.11$ and log $0.928{\sim}1og\;1.18$ for $AUC_t$ and $C_{max}$, respectively). Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating SCD Zaltoprofen tablet was bioequivalent to $Soleton^{\circledR}$ tablet.

Effects of Healing Beats program on patients' anxiety, stress, systolic blood pressure, heart rate and Bis Index after epidural blocking : A randomized controlled trial (Healing Beats 프로그램이 경막외강차단 시술 후 환자의 불안, 스트레스, 수축기 혈압, 심박동수 및 Bis Index에 미치는 효과 : 무작위대조군)

  • Bae, Ik Lyul;Song, Ji Ah
    • Journal of the Korea Academia-Industrial cooperation Society
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    • v.21 no.7
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    • pp.54-65
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    • 2020
  • This randomized pre-post-controlled experimental study determined the effect on patients' anxiety, stress, systolic blood pressure, heart rate and Bis index when the Healing Beats program is applied after epidural blockage. The subjects were selected from the patients who visited the Department of Anesthesiology and Pain for the treatment of epidural blockage and volunteered through the recruitment announcement. A total of 74 sets of data were collected and analyzed with 25 subjects in the experimental group, 24 in the placebo group, and 25 in the control group. The data was analyzed using descriptive statistics, x2-tests, F-tests and repeated measures of ANOVA. As a result of the study, the general characteristics and variables of the experimental group, placebo group, and control group were all the same, and anxiety was measured twice before and after the study. There were significant differences between groups (F=27.175, p<.001), and stress (F=4.78, p<.001), heart rate (F=4.22, p<.001) and the Bis index (F=7.96, p<.001) were analyzed by variance according to population and time. There was a significant difference. However, there was no significant difference in systolic blood pressure (F=1.23, p=.298). In conclusion, the Healing Beats program can be used as an effective and effective intervention for sedation in clinical situations or stressful situations.

The fruit of Acanthopanax senticosus Harms improves arterial stiffness and blood pressure: a randomized, placebo-controlled trial

  • Oh, Eunkyoung;Kim, Youjin;Park, Soo-yeon;Lim, Yeni;Shin, Ji-yoon;Kim, Ji Yeon;Kim, Ji-Hyun;Rhee, Moo-Yong;Kwon, Oran
    • Nutrition Research and Practice
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    • v.14 no.4
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    • pp.322-333
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    • 2020
  • BACKGROUND/OBJECTIVES: Arterial stiffness and endothelial dysfunction are 2 of the independent predictors for cardiovascular disease, while Acanthopanax senticosus Harms (ASH) is a traditional medicinal plant that can improve cardiovascular health. This study aimed to investigate the efficacy of the fruit of ASH on vascular function in apparently healthy subjects. SUBJECTS/METHODS: A 12-week, randomized, double-blind, placebo-controlled design, consisting of healthy adults with at least 2 of the following 3 conditions: borderline high blood pressure (BP; 120 mmHg ≤ systolic BP ≤ 160 mmHg or 80 mmHg ≤ diastolic BP ≤ 100 mmHg), smoking (≥10 cigarettes/day), and borderline blood lipid levels (220 ≤ total cholesterol ≤ 240, 130 ≤ low density lipoprotein cholesterol ≤ 165, or 150 ≤ triglyceride ≤ 220 mg/dL). Randomly assigned 76 subjects who received a placebo or 2 doses of ASH fruit (low, 500 mg/day; high, 1,000 mg/day) completed the intervention. Brachial-ankle pulse wave velocity (baPWV), flow-mediated dilation, carotid intima-media thickness, and BP were measured both at baseline and following the 12-week intervention. Endothelial nitric oxide synthase (eNOS) phosphorylation was assessed by western blotting. RESULTS: Compared with the placebo group, the low-dose group showed more significant changes after the 12-week intervention period in terms of systolic BP (0.1 vs. -7.7 mmHg; P = 0.044), baPWV (31.3 vs. -98.7 cm/s; P = 0.007), and the ratio of phospho-eNOS/eNOS (0.8 vs. 1.22; P = 0.037). CONCLUSIONS: These results suggest that ASH fruit extract at 500 mg/day has the potential to improve BP and arterial stiffness via endothelial eNOS activation in healthy adults with smoking and the tendency of having elevated BP or blood lipid parameters.

Effect of Pretreatment with Lactobacillus delbrueckii and Streptococcus thermophillus on Tailored Triple Therapy for Helicobacter pylori Eradication: A Prospective Randomized Controlled Clinical Trial

  • Tongtawee, Taweesak;Dechsukhum, Chavaboon;Leeanansaksiri, Wilairat;Kaewpitoon, Soraya;Kaewpitoon, Natthawut;Loyd, Ryan A;Matrakool, Likit;Panpimanmas, Sukij
    • Asian Pacific Journal of Cancer Prevention
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    • v.16 no.12
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    • pp.4885-4890
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    • 2015
  • Background: Helicobacter pylori plays an important role in gastric cancer and typical eradication regimens are no longer effective in many countries, including Thailand. The aim of our study was to compare the effect of Lactobacillus delbrueckii and Streptococcus thermophillus on tailored triple therapy for Helicobacter pylori eradication. Materials and Methods: This prospective single-center study was conducted in Thailand. Helicobacter pylori associated gastritis patients were randomized to 2 groups: group 1 (n=100) was tailored triple therapy with placebo (esomeprazole 20 mg bid, clarithromycin 500 mg bid or metronidazole 400 mg tid if clarithromycin resistance and amoxicillin 1000 mg bid), and group 2 was tailored triple therapy plus pretreatment with probiotic containing yogurt. Successful eradication was defined as both negative histology and negative rapid urease test at four weeks after treatment. Results: A total of 200 infected patients were enrolled. PP analysis involved 194 patients: 96 in the tailored triple therapy with placebo group (group 1) and 98 the in tailored triple therapy plus pretreatment with probiotic containing yogurt group (group 2). Successful eradication was observed in 170 (87.6%) patients; by PP analysis, the eradication rate was significantly higher in group 2 (P = 0.04, 95%CI; 0.02-0.13) than in group 1. ITT analysis also showed that the value was significantly higher in the tailored triple threapy plus pretreatment with probiotic containing yogurt group (group 2) (89/100; 89%) than in the tailored triple therapy with placebo group (group 1) (P= 0.01, 95%CI; 0.04-0.15). In terms of adverse events, there was no significant difference between the two groups. Conclusions: Pretreatment with probiotic containing yogurt can improve Helicobacter pylori eradication rates with tailored triple therapy. Adding probiotics does not reduce adverse effects of the medication.