• Title/Summary/Keyword: randomized controlled double blind study

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Effectiveness of tramadol compared to lignocaine as local anesthesia in the extraction of firm teeth: a randomized controlled trial

  • Goel, Manu;Sen, Pinaki;Maturkar, Tushar;Latke, Siddhesh;Dehankar, Tejasvini
    • Journal of Dental Anesthesia and Pain Medicine
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    • v.21 no.3
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    • pp.245-252
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    • 2021
  • Background: The aim of this study was to compare the local anesthetic effect of tramadol with that of lignocaine in the extraction of immobile (grade 0) maxillary first molars. Methods: This was a randomized, double-blind, equally balanced, controlled trial conducted on a sample population of 116 patients. The patients were randomly divided into two groups: group A (control) and group B (study). Group A and group B participants received 1.8 ml of 2% lignocaine without adrenaline and 1.8 ml of 5% tramadol, respectively through the supra-periosteal infiltration technique before extraction. Intraoperative pain was recorded on the Visual Analog Scale (VAS) and was evaluated using two unpaired t-tests. Results: Intraoperative pain was evaluated in both the control and study groups. In the control group, the mean VAS score was 0.71 ± 0.81, while in the study group, the mean intraoperative VAS score was 1.21 ± 0.86, with the difference between the two mean values being statistically significant (P = 0.001). Conclusion: Tramadol has a less potent local anesthetic effect than lignocaine. As a higher dose of tramadol is required to obtain the desired anesthetic effect, it should be used as a supplement to lignocaine in extensive surgical procedures. It can also be used in patients allergic to lignocaine.

An 8-wk, randomized, double-blind, placebo-controlled clinical trial for the antidiabetic effects of hydrolyzed ginseng extract

  • Park, Soo-Hyun;Oh, Mi-Ra;Choi, Eun-Kyung;Kim, Min-Gul;Ha, Ki-Chan;Lee, Seung-Kwon;Kim, Young-Gon;Park, Byung-Hyun;Kim, Dal-Sik;Chae, Soo-Wan
    • Journal of Ginseng Research
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    • v.38 no.4
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    • pp.239-243
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    • 2014
  • Background: To investigate the antidiabetic effects of hydrolyzed ginseng extract (HGE) for Korean participants in an 8-wk, randomized, double-blinded, placebo-controlled clinical trial. Methods: Impaired fasting glucose participants [fasting plasma glucose (FPG) ${\geq}5.6mM$ or < 6.9mM who had not been diagnosed with any disease and met the inclusion criteria were recruited for this study. The 23 participants were randomly divided into either the HGE (n = 12, 960 mg/d) or placebo (n = 11) group. Outcomes included measurements of efficacy (FPG, postprandial glucose, fasting plasma insulin, postprandial insulin, homeostatic model assessment-insulin resistance, and homeostatic model assessment-${\beta}$) and safety (adverse events, laboratory tests, electrocardiogram, and vital signs). Results: After 8 wk of HGE supplementation, FPG and postprandial glucose were significantly decreased in the HGE group compared to the placebo group. No clinically significant changes in any safety parameter were observed. Our study revealed that HGE is a potent antidiabetic agent that does not produce noticeable adverse effects. Conclusion: HGE supplementation may be effective for treating impaired fasting glucose individuals.

Effect of Saccharomyces boulardii CNCM-I 3799 and Bacillus subtilis CU-1 on Acute Watery Diarrhea: A Randomized Double-Blind Placebo-Controlled Study in Indian Children

  • Ghosh, Apurba;Sundaram, Balasubramaniam;Bhattacharya, Piyali;Mohanty, Nimain;Dheivamani, Nirmala;Mane, Sushant;Acharyya, Bhaswati;Kamale, Vijay;Poddar, Sumon;Khobragade, Akash;Thomas, Winston;Prabhudesai, Sumant;Choudhary, Ankita;Mitra, Monjori
    • Pediatric Gastroenterology, Hepatology & Nutrition
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    • v.24 no.5
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    • pp.423-431
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    • 2021
  • Purpose: To assess the effect of combination probiotic Saccharomyces boulardii CNCM-I 3799 and Bacillus subtilis CU-1 in outpatient management of acute watery diarrhea in children. Methods: A randomized double-blind placebo-controlled study was conducted in 180 participants aged six months to five years with acute mild to moderate diarrhea. All were enrolled from six centers across India and centrally randomized to receive S. boulardii CNCM-I 3799 and B. subtilis CU-1 or a placebo along with oral rehydration salts and zinc supplementation. Each participant was followed up for three months to assess recurrence of diarrhea. Results: The mean duration of diarrhea in the probiotic and placebo groups were 54.16 hours and 59.48 hours, respectively. The difference in the duration of diarrhea in those administered with probiotic or placebo within 24 hours of diarrhea onset was 25.21 hours. Furthermore, the difference in duration of diarrhea was 13.84 hours (p<0.05) for participants who were administered with probiotics within 48 hours. There were no significant differences in the stool frequencies between the two arms. After three months, 15% in the probiotic group and 18.5% in the placebo group reported episodes of diarrhea. The mean duration of diarrhea was considerably lower in the probiotic group, 31.02 hours versus 48 hours in placebo (p=0.017). Conclusion: S. boulardii CNCM-I 3799 and B. subtilis CU-1 combination was effective in reducing the duration of diarrhea when administered within 48 hours of diarrhea onset. Similarly, it reduced recurrence of diarrhea and its intensity in the subsequent three months.

Effects of Punica granatum (Pomegranate) Extracts on the Menopause Women

  • Kim, Hyung-Jun;Kwon, Do-Hyeong;Kum, Eun-Joo
    • Biomedical Science Letters
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    • v.16 no.1
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    • pp.53-64
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    • 2010
  • A randomized, double blind, placebo-controlled human intervention study involving 58 menopause women was performed to investigate the effect of pomegranate extracts on menopausal symptoms. The volunteers were randomly distributed into two groups, one taking pomegranate extracts (1.5 g/day) and the other being a placebo by taking oral administration for 8 weeks. The results from this study showed that duration of hot flush and sweating were significantly decreased by taking pomegranate extracts. In addition, menopausal rating scales and the Kuppermann index were significantly decreased in pomegranate extract taking group. This result suggests a possibility that pomegranate extracts can be helpful for menopause women.

Comparative evaluation of efficacy of Physics Forceps versus conventional forceps in pediatric dental extractions: a prospective randomized study

  • Elicherla, Sainath Reddy;Bandi, Sujatha;Nunna, Mahesh;Saikiran, Kanamarlapudi Venkata;Sahithi, Varada;Nuvvula, Sivakumar
    • Journal of Dental Anesthesia and Pain Medicine
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    • v.21 no.6
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    • pp.547-556
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    • 2021
  • Background: This study aimed to determine the efficacy of Physics Forceps in pediatric dental extractions. Methods: This was a double-blind, randomized controlled trial with a parallel-arm design and identical allocation ratio (1:1). Children (n=104) were randomly divided into two groups for extraction of mandibular primary teeth (group I: Physics Forceps; group II: conventional forceps). The outcome variables assessed in the study were the time taken for extraction, pre- and postoperative anxiety (using RMS pictorial scale), incidence of fractured teeth, and postoperative pain on the first and third days (using the Wong-Baker faces pain scale). Results: A significant reduction (P < 0.001) in intraoperative time, anxiety, and incidence of tooth fracture was confined to group I. The pain significantly reduced from the first to the third postoperative day in both groups, but the mean reduction in RMS scores in the physics forceps group was far better than that in the conventional forceps group. Conclusion: Physics Forceps aid in extraction of primary teeth with minimal trauma to supporting structures, as well as reducing anxiety in the pediatric population.

Effect of Onkyung-tang on Cold Hypersensitivity on Feet: A Multi-center Double-blind Randomized Controlled Trial (온경탕이 족부냉증에 미치는 영향에 대한 다기관 이중맹검 무작위 대조군 연구)

  • Kwon, Na-Yoen;Yoo, Joon-Sang;Kim, Hyeong-Jun;Lee, Dong Nyung
    • The Journal of Korean Obstetrics and Gynecology
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    • v.33 no.3
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    • pp.149-174
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    • 2020
  • Objectives: This study was aimed to figure out the effect of Onkyung-tang (OKT) on cold hypersensitivity on feet in female patients. Methods: This study was designed to implement multi-center randomized clinical trial in three korean medical hospitals. The female patients who were enrolled in this study were 112 women who suffered from cold hypersensitivity on feet. They were randomly allocated into OKT group or control group in 1:1 ratio. The primary outcome was change in score of visual analogue scale of hypersensitivity on feet, and the secondary outcomes were thermometer of LU4, PC8, ST32, LR3, visual analogue scale of hypersensitivity on hands, result of cold stress test, and score of World Health Organization Quality of Life-BREF. Results: In both group, the VAS of hypersensitivity on feet and hands was decreased while taking the medicine, and the effect of decreasing the VAS continues for the 4 weeks after the end of medication (p<0.001, 0.003, 0.001). In OKT group, the body temperature difference in lower extremity (ST32-LR3) was steadily decreased at every visit and it was statistically significant(p=0.003, <0.001). On the other hand, in control group, the body temperature difference in lower extremity was decreased only while taking the medicine (p<0.001). Conclusions: OKT significantly reduced discomfort coldness on feet in patients, and the effect of treatment was maintained at least for four weeks after medication.

APPLICATION OF 0.2% HYALURONIC ACID GEL IN ORAL SURGICAL WOUND : A RANDOMIZED DOUBLE-BLIND STUDY (구강내 외과적 창상 치유에서 0.2% hyaluronic acid gel의 유효성에 대한 이중 맹검 연구)

  • Kim, Jae-Yoon;Lee, Jin-Yong;Bae, Kwang-Hak;Lee, Jong-Ho
    • Journal of the Korean Association of Oral and Maxillofacial Surgeons
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    • v.34 no.2
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    • pp.157-165
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    • 2008
  • The aim of this study was to evaluate the efficacy of a topical 0.2% hyaluronic acid (HA) preparation in the management of wound after removal of arch bar for facial bone fracture and a suture site after orthognatic, oral cancer or oral surgery. Forty patients participated in a randomized, placebo controlled, double-blind trial to evaluate the efficacy of the topical HA and preparation. HA topically applied to the wound after removal of arch bar or stitch out, 3 times a day for 4 weeks. Evaluation is performed once a week for 4 weeks. For subjective evaluation, relative pain reduction in visual analog scale (VAS) and existence of heat sensation was accessed. For objective evaluation, gross evaluation, papilla index, existence of wound dehiscence, redness and swelling was checked. The same evaluation was performed in each arch bar group and suture group. For whole subject, 0.2% HA group resulted higher reduction than placebo group in pain of site in first week with significancy. Same findings were seen other weeks but there was no significancy. 0.2% HA group had better result than placebo in objective evaluation (papilla index, wound dehiscence, redness and swelling), but in gross evaluation placebo had better result than 0.2% HA group with no significancy. Subject was divided into suture group and arch bar group. Same aspect was seen, but only suture group had significancy not arch bar group in pain reduction score. 0.2% HA group resulted higher reduction than placebo group in pain of site in first week with significancy, especially in suture group. It reveals topical application of HA in wound especially suture site reduced pain in early stage. And 0.2% HA group had better result than placebo in papilla index, redness and swelling with no statistical significancy. In conclusion, HA has effect of pain reduction and healing promotion in the mucosal wound after oral surgery.

Effects of Interferential Current Treatment on Pain, Functional Ability, and Health-Related Quality of Life in Chronic Stroke Patients with Lumbago; A Randomized Controlled Study

  • Jung, Kyoung-Sim;In, Tae-Sung
    • Journal of the Korean Society of Physical Medicine
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    • v.15 no.1
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    • pp.25-32
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    • 2020
  • PURPOSE: This study examined the efficacy of an interferential current (IFC) treatment on the improvement of pain, disability, and quality of life in stroke patients with lumbago. METHODS: A double-blind, randomized clinical trial was conducted on 40 stroke patients with lumbago. The patients were allocated randomly into two groups: the IFC treatment group (n= 20) and the placebo treatment group (n= 20). The IFC group received 30 minutes of IFC treatment on the lumbar region, while the placebo group received IFC treatment but without real electrical stimulation. The intervention was administered five days a week for four weeks. The primary outcomes of pain intensity were measured using a visual analogue scale. The secondary measurements included the Barthel Index, Oswestry Disability Index (ODI), and health-related quality of life (HRQoL). RESULTS: The measurements were conducted before and after the two-week intervention period. Compared to the placebo treatment group, the IFC treatment group showed significantly greater improvement in the pain intensity (p<.05), ODI (p<.05), and SF-36 (p<.05) at the end of the intervention. No significant differences in the Barthel Index were found between the two groups. CONCLUSION: These findings show that an IFC treatment can improve pain, functional ability, and quality of life, highlighting the benefits of somatosensory stimulation from IFC in stroke patients with lumbago.

Effects of Interferential Current Treatment on Pain, Disability, and Balance in Patients with Chronic Low Back Pain: A Randomized Controlled Study

  • Jung, Kyoung-Sim;In, Tae-Sung
    • Journal of the Korean Society of Physical Medicine
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    • v.15 no.3
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    • pp.21-27
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    • 2020
  • PURPOSE: This study investigated the efficacy of interferential current (IFC) treatment on the improvement of pain, disability, and balance in patients with chronic nonspecific low back pain. METHODS: A double-blind randomized clinical trial was conducted with 40 patients with chronic nonspecific low back pain. The patients were randomly allocated into two groups: the IFC treatment group (n = 20) and the placebo treatment group (n = 20). The IFC group received 30 minutes of IFC treatment on the lumbar region, while the placebo group received IFC treatment without real electrical stimulation. The intervention was administered five days a week for two weeks. RESULTS: The primary outcomes of resting pain and pain during functional movement were measured by a visual analogue scale. The secondary measurements included the Oswestry disability index (ODI) for low back pain and postural sway. The measurements were performed before and after the two-week intervention period. Compared to the placebo treatment group, the IFC treatment group showed significantly greater improvement in pain during anterior trunk flexion in the standing position (p = .029), ODI (p = .039), and postural sway when subjects stood with their eyes closed (p = .010) at the end of the intervention. CONCLUSION: Our findings show that IFC treatment can improve pain, disability, and postural sway, thus, highlighting the benefits of somatosensory stimulation from IFC.

A Systematic Review on the Efficacy of Fire Needling for the Treatment of Acne (여드름의 화침치료 효과에 대한 체계적 문헌 고찰)

  • Kim, Eui Byeol;Kang, Ki Wan;Kim, Min Ji;Kang, Ja Yeon;Jeong, Min Jeong;Jang, In Soo
    • Journal of Acupuncture Research
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    • v.33 no.2
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    • pp.151-164
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    • 2016
  • Objectives : The purpose of this study is to review clinical studies about the efficacy of fire needling for the treatment of acne vulgaris. Methods and Results : In this review, Oasis, NDSL, CNKI, PubMed, Cochrane, J STAGE and CINII were used as the main databases for searching for medical journals, using the keywords "acne and fire needling"," acne and fire needle"," acne and fire acupuncture", and" acne and red hot needle". The initial search range included only randomized controlled trials (RCTs), and papers not matching inclusion criteria were excluded. Initially a total of 108 studies were found, with ten being excluded during title and abstract screening. After scanning 98 papers, a total of 31 RCTs were selected and analyzed. In the 31 RCTs, patients with acne were randomized into groups for treatment and control. Specifically, the treatment group received fire needling, while the control group were concurrently given other treatments. The results of the completed studies have shown that the treatment group receiving fire needling demonstrated significant improvement compared to the control group. Conclusion : During our study, it was verified that the efficacy of fire needling for the treatment of acne vulgaris was both significant and meaningful. Therefore, fire needling can be a safe and effective alternative treatment for acne. However, to confirm this result, further investigation in a traditional clinic is required, accompanied by high quality studies including randomized, placebo-controlled double-blind trials.