• Title/Summary/Keyword: Double-blind

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Clinical Trial to Evaluate the Efficacy of Extract of Citri Pericarpium on Serum Lipid Profiles in Subjects: a Randomized, Double-blind (혈중지질에 대한 진피추출물의 유효성 평가를 위한 인체적용시험 : 무작위배정, 이중맹검)

  • Lee, Jin-Sang;Do, Eun-Ju;Kwak, Min-A;Park, Hyun-Jin;Ha, Il-Do;Sung, Ki-Jun;Kim, Mi-Ryeo
    • The Korea Journal of Herbology
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    • v.26 no.1
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    • pp.125-132
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    • 2011
  • Objectives : This study was performed to evaluate the efficacy of extract from Citri Pericarpium (CP) on lipid-lowering effect in semi-healthy subjects with increased serum levels of total cholesterol and triglyceride. Methods : A experimental group (n=45) and placebo group (n=46) were randomly established based on the plasma lipid profiles (triglyceride, total cholesterol etc.) in the semi-healthy subjects, then all subjects randomly took experimental or placebo capsules, which contain 1,200 mg of CP or the same dose of soluble starch per day with regular meals for 8 weeks by double-blind method. Results : One-hundred forty (140) subjects were screened, then 91 subjects enrolled in the study. No serious adverse events were reported for trial period. The CP treatment showed statistically significant decrease in serum levels of triglyceride both at 4-weeks (p<0.01) and at 8-weeks (p=0.0001). Futhermore, there was significant difference in the triglyceride levels between CP-treated and placebo group. The CP-treated but not placebo group, experienced decrease in serum levels of total cholesterol at 8-weeks. Then there was no significant difference in the total cholesterol levels between the two groups. In addition, statistically significant difference of AST, ALT, ${\gamma}$-GT serum levels wasn't shown before and after trial in two groups. Conclusion : These results demonstrate that CP can significantly suppress the elevated triglyceride but not total cholesterol level. Therefore, CP may play a role in the improvement of blood lipid levels, as an effective functional food.

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.

The Effect of Nefopam on Postoperative Fentanyl Consumption: A Randomized, Double-blind Study

  • Moon, Jee Youn;Choi, Sang Sik;Lee, Shin Young;Lee, Mi Kyung;Kim, Jung Eun;Lee, Ji Eun;Lee, So Hyun
    • The Korean Journal of Pain
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    • v.29 no.2
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    • pp.110-118
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    • 2016
  • Background: Nefopam is a non-opioid, non-steroidal, centrally acting analgesic drug. The concomitant use of opioids and nefopam is believed to have many advantages over the administration of opioids alone for postoperative pain management. We conducted a randomized, double-blind study to determine the fentanyl-sparing effect of co-administration of nefopam with fentanyl for postoperative pain management via patient controlled analgesia (PCA). Methods: Ninety female patients who underwent laparoscopic total hysterectomy under general anesthesia were randomized into 3 groups, Group A, fentanyl $1,000{\mu}g$; Group B, fentanyl $500{\mu}g$ + nefopam 200 mg; and Group C, fentanyl $500{\mu}g$ + nefopam 400 mg, in a total volume of 100 ml PCA to be administered over the first 48 h postoperatively without basal infusion. The primary outcome was total fentanyl consumption during 48 h; secondary outcomes included pain scores and incidence of side effects. Results: Eighty-one patients were included in the analysis. The overall fentanyl-sparing effects of PCA with concomitant administration of nefopam during the first 48 h postoperatively were 54.5% in Group B and 48.9% group C. Fentanyl use was not significantly different between Groups B and C despite the difference in the nefopam dose. There were no differences among the three groups in terms of PCA-related side effects, although the overall sedation score of Group B was significantly lower than that of Group A. Conclusions: The concomitant administration of nefopam with fentanyl for postoperative pain management may allow reduction of fentanyl dose, thereby reducing the risk of opioid-related adverse effects.

Sewing Method of Inner Collar of Women's Jeogori in Modern Korea (근대이후 저고리 안감깃 봉제방법 소고)

  • Kim, Jin-Hong;Cho, Woo-Hyun
    • Journal of the Korea Fashion and Costume Design Association
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    • v.10 no.2
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    • pp.139-147
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    • 2008
  • This study aims to investigate and analyze sewing methods according to the shape of the inner collar among women's jeogories in order to understand such sewing techniques, which has emerged during modern Korea, and has utilized diversly for the shape of the jeogori's inner collar and as part of the inner collar. The study was conducted on relics possessed between 1900 to 1990, or 515 pieces of jeogories. Jeogories were classified into single-layered and double-layered jeogories according to the shape of their composition. Inner collar shapes of jeogories have also been categorized. It was found that single-layered jeogories comprise 49 inner collars with shapes identical to those of the outer collars. Double-layered jeogories comprise of the following three types: 43 pieces of godae close, 18 pieces in which the inner collar of the outer bodice are cut without a connecting line and the inner collar of the godae and inner bodice are suspended, and 405 pieces in which the share of the inner collar is identical to that of the outer collar. From the shapes of inner collars mentioned above, the following sewing methods have been derived: 1. To sew the inner collar of single-layered jeogories, a seaming technique had been used. 2. Among the inner collars of a double-layered jeogori, godae close was sewn with only a short part of the godae by using a lining, and then finished with overage and blind stitches. Godae close was a covenient way to attach inner collars, and also saved much time. 3. Inner collars with shapes identical to the outer collar are divided into two groups: those with outer collars cut out fellowing the cloth without seam and shifted towards the linings and used as an inner collar, and those with outer collars made of outer linings and inner collar of inner linings. To sew the collar, paste and needlework had been employed, where the methods of needlework were divided into blind stitch, overage stitch, and catch stitch. In sewing with paste, only godae was blind stitched or overage stitched, and the remainder had been painted with paste or the collar had been finished with heated soldering iron after the entire inner collar was painted with paste.

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A Prospective, Multi-Center, Double-Blind, Randomized Study to Evaluate the Efficacy and Safety of the Synthetic Bone Graft Material DBM Gel with rhBMP-2 versus DBM Gel Used during the TLIF Procedure in Patients with Lumbar Disc Disease

  • Hyun, Seung-Jae;Yoon, Seung Hwan;Kim, Joo Han;Oh, Jae Keun;Lee, Chang-Hyun;Shin, Jun Jae;Kang, Jiin;Ha, Yoon
    • Journal of Korean Neurosurgical Society
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    • v.64 no.4
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    • pp.562-574
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    • 2021
  • Objective : This study is to evaluate the efficacy and safety of demineralized bone matrix (DBM) gel versus DBM gel with recombinant human bone morphogenetic protein-2 (rhBMP-2) used in transforaminal lumbar interbody fusion (TLIF). Methods : This study was designed as a prospective, multi-center, double-blind method, randomized study. All randomized subjects underwent TLIF with DBM gel with rhBMP-2 group (40 patients) as an experimental group or DBM gel group (36 patients) as a control group. Post-operative observations were performed at 12, 24, and 48 weeks. The spinal fusion rate on computed tomography scans and X-rays films, Visual analog scale pain scores, Oswestry disability index and SF-36 quality of life (QOL) scores were used for the efficacy evaluation. The incidence rate of adverse device effects (ADEs) and serious adverse device effects (SADEs) were used for safety evaluation. Results : The spinal fusion rate at 12 weeks for the DBM gel with rhBMP-2 group was higher with 73.68% compared to 58.82% for the DBM gel group. The 24 and 48 weeks were 72.22% and 82.86% for the DBM gel with rhBMP-2 group and 78.79% and 78.13%, respectively, for the DBM gel group. However, there were no significant differences between two groups in the spinal fusion rate at 12, 24, and 48 weeks post-treatment (p=0.1817, p=0.5272, p=0.6247). There was no significant difference between the two groups in the incidence rate of ADEs (p=0.3836). For ADEs in the experimental group, 'Pyrexia' (5.00%) was the most common ADE, followed by 'Hypesthesia', 'Paresthesia', 'Transient peripheral paralysis', 'Spondylitis' and 'Insomnia' (2.50%, respectively). ADEs reported in control group included 'Pyrexia', 'Chest discomfort', 'Pain', 'Osteoarthritis', 'Nephropathy toxic', 'Neurogenic bladder', 'Liver function analyses' and 'Urticaria' (2.86%, respectively). There was no significant difference between the two groups in the incidence rate of SADEs (p=0.6594). For SADE in the experimental group, ''Pyrexia' and 'Spondylitis' were 2.50%. SADE reported in the control group included 'Chest discomfort', 'Osteoarthritis' and 'Neurogenic bladder'. All SADEs described above were resolved after medical treatment. Conclusion : This study demonstrated that the spinal fusion rates of DBM gel group and DBM gel with rhBMP-2 group were not significantly different. But, this study provides knowledge regarding the earlier postoperative effect of rhBMP-2 containing DBM gel and also supports the idea that the longer term follow-up results are essential to confirm the safety and effectiveness.

Antidepressant and Suicide (항우울제와 자살)

  • Lee, Boung-Chul;Ham, Byung-Joo
    • Korean Journal of Biological Psychiatry
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    • v.13 no.4
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    • pp.244-251
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    • 2006
  • Depression is a frequent cause of suicide. Although there have been reports that SSRIs might increase suicidal ideations and behaviors, most studies found antidepressants are effective treatments of suicidal ideations and behaviors. Antidepressants have also been shown to have prophylactic effects in preventing suicidal behaviors. Most double-blind studies do not suggest a causal relationship between antidepressant and the increased suicidality. Our review results suggest that the undertreatments of depression are more significant problems with the use of antidepressants in suicidal patients.

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The efficacy of eradication therapy and Korea Red Ginseng administration on Helocobacter pylori-associated chronic gastritis double blind, placebo controlled study (헬리코박터 필로리 양성 만성위염환자에서 제균약제 및 고려 홍삼정 (정관장) 투여에 따른 치료효과 이중 맹검, 위약비교 연구)

  • Yeo, Mal-Hui;Lee, Jeong-A;Kim, Dong-Gyu;Park, Hui-Jin;Jeong, Jae-Yong;Kim, Yeong-Bae;Lee, Gi-Myeong;Lee, Gwang-Jae;Kim, Jin-Hong
    • Proceedings of the Ginseng society Conference
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    • 2005.05a
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    • pp.8-11
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    • 2005
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