• Title/Summary/Keyword: randomized clinical trial

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A Crossover Clinical Trial to Determine the Effect of Siguan(Four Gates) Points on Gastrointestinal Motility Suppressed by Loperamide Administration (Loperamide로 억제된 위장관 운동에 대한 사관혈의 자침효과: 무작위배정, 단일눈가림, 교차설계, 대조 임상시험)

  • Oh, Dal-Seok;Jung, So-Young;Kim, Ae-Ran;Kang, Wee-Chang;Park, Ji-Eun;Koo, Chang-Mo;Choi, Jun-Yong;Jung, Hee-Jung;Choi, Sun-Mi;Son, Chang-Gue
    • The Journal of Korean Medicine
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    • v.29 no.1
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    • pp.1-6
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    • 2008
  • Objective : To investigate the therapeutic effect of manual acupuncture at Siguan (four gates, bilateral LI4 and LR3) on suppression of gastrointestinal motility. Methods : A single blind, randomized, sham-acupuncture controlled, crossover study was conducted. Twenty healthy male subjects were admitted at hospital, and gastrointestinal motility suppression was induced by loperamide administration. Just after intake of 20 radio-markers, four gates or sham acupoint treatments were administered every 12 hours, 4 times over 48 hours. Gastrointestinal motility was evaluated by radiographic distribution of the radiomarkers at stomach or ileum, ascending, transverse, descending colon, sigmoid/rectum, and outside body at serial time points (0, 6, 12, 24, and 48 h). Results : Four gates acupuncture activated gastrointestinal movement as evidenced by significantly changed distributionof radio-makers at 6, 12, and 48 hours (P < 0.0001, P = 0.001, and P = 0.03, respectively) in Cochran-Mantel-Haenszel statistics. No serious adverse events occurred in either group. Conclusions : This study showed a scientific clinical relevance of four gates acupuncture to gastrointestinal disorders.

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Effect of Hanwoo Diets Containing Linseed on Plasma Cholesterol Levels of Humans to Beef Consumption and Change in n-6/n-3 Fatty Acid of Loin Fat (아마씨앗 첨가 한우사료가 등심 지방의 n-6/n-3 변화 및 이를 섭취한 사람의 혈중 콜레스테롤 함량에 미치는 영향)

  • Park, Sang-Oh;Park, Byung-Sung;Yuh, In-Suh;Hwangbo, Jong;Bang, Han-Tae
    • Journal of the Korean Applied Science and Technology
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    • v.31 no.2
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    • pp.265-276
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    • 2014
  • The purpose of this study was to evaluate the effect on lowering blood LDL-C in an adult human, by taking n-6/n-3 balanced Hanwoo beef and reducing n-6/n-3 in loin of Hanwoo beef. The randomized complete block design was used to conduct an experiment with a total of 20 castrated Hanwoo cattles, which were divided into two groups. Each group had 10 cattles, and the control group consisted of absence of linseed, while n-3 treatment group (n-3 group) had linseed. The results showed that n-6/n-3 in loin and blood was decreased to under 4:1 in n-3 group, while oleic acid as an monounsaturated fatty acid was increased by 52.79% compared to the control group. In above 70% of the clinical subjects who ate the balanced Hanwoo beef, the blood triglyceride, total cholesterol, and LDL-C were decreased by 25.35, 5.22, and 17.59%. However, in the subjects who ate the imported beef, and not the common Hanwoo beef, the same parameters were increased by 9.05, 8.21, and 21.70%, respectively. When the balanced Hanwoo beef were eaten, HDL-C were increased by 6.07% but the imported beef and common Hanwoo beef had those values decreased by 14.46 and 11.46%, respectively. The blood glucose was decreased by 6.42 and 11.82% in the subjects who ate balanced Hanwoo beef and common Hanwoo beef, respectively but the subjects who ate the imported beef had an increase by 15.19%.

Clinical Study on Food Safety evaluation of Panax ginseng (고려인삼의 식품 안전성에 관한 임상 연구)

  • Kim, Dong Hwi;Xu, Yong Hua;Kim, Young Chang;Bang, Kyong Hwan;Kim, Jang Uk;Cha, Seon Woo;He, Zhong Mei;Yang, He;Jang, In Bok;Zhang, Lian Xue
    • Korean Journal of Medicinal Crop Science
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    • v.23 no.3
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    • pp.185-189
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    • 2015
  • In this study, the clinical safety and toxicology of oral ingestion of supplement capsules containing ginseng radix was investigated in healthy young volunteers. This study was a pilot randomized, double blinded, placebo controlled trial. The healthy volunteers were divided into 6 groups of 20 each (10 males and 10 females). They took the ginseng powder for 35 days (3g/day) for safety evaluation. There were measured general healthy levels such as hematological, biochemical and electrocardiographic parameters. After the first week, besides Korean white ginseng the other treatments led to an significant increase of white blood cells. Korean red ginseng increased UREA (blood urea nitrogen) in healthy volunteers, but it didn't exceed the range of normal values, and in the subsequent process of treatment there is no effect of elevating UREA. After the three weeks, Korean white ginseng showed relatively low the content of blood glucose and low-density lipoprotein cholesterol. After the five weeks, compared with the other treatments, Korean red ginseng increased white blood cells, platelet distribution width and average volume of platelet. Korean white ginseng decreased low-density lipoprotein cholesterol. American ginseng decreased blood creatinine in healthy volunteers. In conclusion, through test the blood routine, urine routine, liver function, renal function, blood glucose, blood lipid and electrocardiogram, the healthy volunteers continuous taking ginseng for 35 days (3 g/day) is safe and reliable, and have no obvious adverse reactions and side effects.

Effects of Unripe Rubus Coreanus Extract on Upper Body Obesity: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial (미숙과 복분자 추출물의 상체비만 개선 효과: 무작위배정, 이중눈가림, 위약-대조 임상연구)

  • Ha, Ki Chan;Kim, Hye Mi;Baek, Hyang Im;Jeong, Da Young;Kim, Eun;Lee, Ki Hoon;Kim, Ha Rim;Kwon, Kang Beom;Kim, Sunoh;Lee, Jung Han
    • Journal of Korean Medicine Rehabilitation
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    • v.31 no.4
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    • pp.117-127
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    • 2021
  • Objectives Previously, we demonstrated that a 5% ethanol extract of unripe Rubus coreanus (5-uRCK) and ellagic acid has hypocholesterolemic and antiobesity activity in high-fat diet-fed animals. Therefore, we conducted a clinical study on the anti-obesity effect of 5-uRCK in 140 Korean adults (aged 19-70 years, body mass index (BMI) ≥25 kg/m2). Methods The participants were randomly assigned to two groups and were administered the placebo (n=70) or 5-uRCK extract (800 mg, n=70) daily for 12 weeks. The subjects were instructed to maintain their usual dietary intake and normal physical activity. Anthropometrics, body composition (dual-energy X-ray absorptiometry), and blood parameters were compared between the two groups. Results Average body weight and BMI did not show any significant changes; however, changes in upper body fat mass between the two groups was significantly different, as determined using analysis of covariance adjusted for baseline of percent body fat and drinking units. Moreover, Although not significant, the trunk fat mass and percent trunk fat tended to decrease after 5-uRCK supplementation. There was no significant difference in other laboratory biomarkers between the two groups. All safety parameters were within normal ranges in the both group. Conclusions In the present study, 5-uRCK significantly reduced upper body fat in obese subjects after 12 weeks, which indicates that it may help improve android-type obesity. Furthermore, the supplement is safe and well tolerated.

Randomized clinical trial to evaluate the efficacy and safety of two types of sandblasted with large-grit and acid-etched surface implants with different surface roughness

  • Jeon, Jun-Hyung;Kim, Min-Joong;Yun, Pil-Young;Jo, Deuk-Won;Kim, Young-Kyun
    • Journal of the Korean Association of Oral and Maxillofacial Surgeons
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    • v.48 no.4
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    • pp.225-231
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    • 2022
  • Objectives: This study aims to evaluate the efficacy and safety of two types of sandblasted with large-grit and acid-etched (SLA) surface implants with different surface roughness. Patients and Methods: This study was conducted based on a clinical record review of 55 patients (mean age, 53.00 years). A total of 80 SLA surface implants was placed. Among the 80 implants, 38 implants placed in 29 subjects had surface roughness (Ra) of 3.09 ㎛ (test group, TG), while the other 42 implants placed in 31 subjects had a surface roughness (Ra) of 2.50 ㎛ (control group, CG). A comparison was made of implant primary/secondary stability; success and survival rates; marginal bone loss; and soft tissue assessment including probing pocket depth (PPD), plaque index (PI), gingival index (GI), and bleeding on probing (BOP) between the groups at 1 year after implant placement. Results: Among the implants that were initially registered, 1 from the TG and 4 from the CG dropped out, leaving 37 implants in the TG and 38 implants in the CG to be traced and analyzed. Although 1 TG case showed unstable primary stability, all cases showed stable secondary stability. Success and survival rates at 1 year after implant placement were 100% in both groups. Marginal bone loss was 0.07 mm and 0.00 mm for the TG and CG, respectively, but the difference was not significant. Among the several parameters for evaluation of soft tissue, the TG showed lower PI at 1 year after implant placement (TG=0.00, CG=0.29; P=0.0004), while the remaining categories showed no significant difference between the groups. Conclusion: This study shows that the two types of SLA implants with different surface roughness have no difference in efficacy or safety. Therefore, both of the implants can be used safely and with promising outcomes.

Study on the Anti-stress Effect of Chenwangbosim-Dan Extract∘Fermented Rice Extract (GABA ː gamma-aminobutyric acid 30%) Complex : A double-blind, randomized, placebo-controlled study (천왕보심단(天王補心丹)∘쌀발효추출물(GABAːgamma-aminobutyric acid 30%) 복합물의 항(抗)스트레스에 대한 유효성 연구ː무작위 배정 및 이중맹검)

  • Choyoung, Hong;Seo, Sang Gwon;Seunggon, Na;Hosong, Cho;Mi-Kyung, Lee;Mu Hyun, Jin;Seok-Seon, Roh;Youngsung, Ju
    • The Korea Journal of Herbology
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    • v.38 no.2
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    • pp.1-7
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    • 2023
  • Objectives : From this study, we sight to identify Anti-stress effect of Chenwangbosim-Dan (Tianwangbuxin-Dan) Extract∘Fermented Rice Extract (GABA : gamma-aminobutyric acid 30%) Complex Methods : In order to measure the degree of functional evaluation of tension relief due to stress, it was evaluated whether the psychological indicators VAS(Visual Analog Scale) and POMS(Profile Of Mood State) were improved. Which is generally used for stress measurement and has a high frequency of clinical use. All clinical trial subjects were required to take the drug once a day at 9 ± 30 min in the morning for 2 weeks. Results : After intake, the group that Chenwangbosim-Dan(Tianwangbuxin-Dan) Extract∘Fermented Rice Extract (GABA : gamma-aminobutyric acid 30%) Complex had a statistically significant improvement effect compared to before intake due to an improved 30.81% of the VAS scores. The POMS-T score improved 54.13%, the POMS-V score improved 117.5% and the POMS-F score improved 59%, which had a statistically significant effect compared to Placebo group (p<0.001). There is a significant difference between two group, so even considering the placebo effect, the anti stress effect was confirmed in the Chenwangbosim-Dan (Tianwangbuxin-Dan) Extract∘Fermented Rice Extract (GABA : gamma-aminobutyric acid 30%) Complex intake group. Conclusions : The above results showed that the Chenwangbosim-Dan(Tianwangbuxin-Dan) Extract∘Fermented Rice Extract (GABA : gamma-aminobutyric acid 30%) Complex had an anti-stress effect. Therefore, it is expected to be developed as a safe and comfortable mental care health functional food that can reduce the risk of drug abuse.

A Prospective Randomized Comparative Clinical Trial Comparing the Efficacy between Ondansetron and Metoclopramide for Prevention of Nausea and Vomiting in Patients Undergoing Fractionated Radiotherapy to the Abdominal Region (복부 방사선치료를 받는 환자에서 발생하는 오심 및 구토에 대한 온단세트론과 메토클로프라미드의 효과 : 제 3상 전향적 무작위 비교임상시험)

  • Park Hee Chul;Suh Chang Ok;Seong Jinsil;Cho Jae Ho;Lim John Jihoon;Park Won;Song Jae Seok;Kim Gwi Eon
    • Radiation Oncology Journal
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    • v.19 no.2
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    • pp.127-135
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    • 2001
  • Purpose : This study is a prospective randomized clinical trial comparing the efficacy and complication of anti-emetic drugs for prevention of nausea and vomiting after radiotherapy which has moderate emetogenic potential. The aim of this study was to investigate whether the anti-emetic efficacy of ondansetron $(Zofran^{\circledR})$ 8 mg bid dose (Group O) is better than the efficacy of metoclopramide 5 mg lid dose (Group M) in patients undergoing fractionated radiotherapy to the abdominal region. Materials and Methods : Study entry was restricted to those patients who met the following eligibility criteria: histologically confirmed malignant disease; no distant metastasis; performance status of not more than ECOG grade 2; no previous chemotherapy and radiotherapy. Between March 1997 and February 1998, 60 patients enrolled in this study. All patients signed a written statement of informed consent prior to enrollment. Blinding was maintained by dosing identical number of tablets including one dose of matching placebo for Group O. The extent of nausea, appetite loss, and the number of emetic episodes were recorded everyday using diary card. The mean score of nausea, appetite loss and the mean number of emetic episodes were obtained in a weekly interval. Results : Prescription error occurred in one patient. And diary cards have not returned in 3 patients due to premature refusal of treatment. Card from one patient was excluded from the analysis because she had a history of treatment for neurosis. As a result, the analysis consisted of 55 patients. Patient characteristics and radiotherapy characteristics were similar except mean age was $52.9{\pm}11.2$ in group M, $46.5{\pm}9.5$ in group O. The difference of age was statistically significant. The mean score of nausea, appetite loss and emetic episodes in a weekly interval was higher in group M than O. In group M, the symptoms were most significant at 5th week. In a panel data analysis using mixed procedure, treatment group was only significant factor detecting the difference of weekly score for all three symptoms. Ondansetron $(Zofran^{\circledR})$ 8 mg bid dose and metoclopramide 5 mg lid dose were well tolerated without significant side effects. There were no clinically important changes In vital signs or clinical laboratory parameters with either drug. Conclusion : Concerning the fact that patients with younger age have higher emetogenic potential, there are possibilities that age difference between two treatment groups lowered the statistical power of analysis. There were significant difference favoring ondansetron group with respect to the severity of nausea, vomiting and loss of appetite. We concluded that ondansetron is more effective anti-emetic agents in the control of radiotherapy-induced nausea, vomiting, loss of appetite without significant toxicity, compared with commonly used drug, i.e., metoclopramide. However, there were patients suffering emesis despite the administration of ondansetron. The possible strategies to improve the prevention and the treatment of radiotherapy-induced emesis must be further studied.

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A Randomized, Double-Blind, Placebo-Controlled Trial of Early Ursodeoxycholic Acid Administration for Prevention of Total Parenteral Nutrition-Induced Hepatobiliary Complications (총정맥영양법의 간담도 합병증에 대한 Ursodeoxycholic Acid 조기투여의 이중맹검 위약대조군 연구)

  • Choe, Yon-Ho;Beck, Nam-Sun;Kim, Ji-Hee;Lee, Suk-Hyang;Park, Tae-Sung
    • Pediatric Gastroenterology, Hepatology & Nutrition
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    • v.5 no.2
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    • pp.174-180
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    • 2002
  • Purpose: Ursodeoxycholic acid (UDCA) is known to decrease hepatic injury by promoting the biliary secretion of retained toxic endogenous bile acids in hepatobiliary diseases complicated by total parenteral nutrition (TPN). However, most studies have focused on treatment for complications after TPN. We investigated the preventive role of early administration of UDCA in TPN-induced hepatobiliary complications by a randomized, double-blind, placebo-controlled trial. Methods: Between May 2000 and May 2002, thirteen patients, who were given TPN more than 10 days in the hospital, were assigned randomly to two groups. One was the case group (7 patients) who were given UDCA simultaneously with TPN regimen, and the other, the control group (6 patients) who were given placebo. Their age ranged from 1 day to 13 years. They were affected with diseases impossible for enteral nutrition, such as prematurity, cerebral palsy, chronic diarrhea, anorexia nervosa, pancreatitis, and cyclic vomiting. The duration of TPN ranged from 10 to 70 days. Hematologic parameters including liver function test were measured at regular intervals, and the duration, composition, administration rate, total calorie of TPN were recorded. The serum levels of total bilirubin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase were compared between groups after cessation of the study. Results: The autoregressive coefficient of the control group was 0.4419 (p=0.0651) in bilirubin, -0.0431 (p=0.7923) in AST, 0.2398 (p=0.2416) in ALT, and 0.2459 (p=0.1922) in alkaline phosphatase by mixed procedure model when the parameters were referred to the case group. Conclusion: The serum level of total bilirubin did not increase in comparison with that of the control group, but statistically insignificant, when both TPN and UDCA were administered simultaneously from the beginning.

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The Efficacy of Nebulized 3 Percent Hypertonic Saline Solution and Fenoterol in Infants with Bronchiolitis (영아 세기관지염에서 3% 고장성 식염액과 Fenoterol 병용흡입 치료의 효과)

  • Park, Joon Young;Jeong, Young Mi;Jeong, Soo Jin;Seo, Son Sang
    • Clinical and Experimental Pediatrics
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    • v.48 no.5
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    • pp.518-522
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    • 2005
  • Purpose : To evaluate the effect of inhaled hypertonic saline solution in hospitalized infants with bronchiolitis. Methods : A randomized double blind trial was performed from October 2003 to May 2004. A total of eighty patients <1 year of age with a clinical diagnosis of acute viral bronchiolitis were enrolled and assigned to receive either of the following : inhalation of 2 mL(0.5 mg) fenoterol added to 2 mL of 0.9 percent saline solution(group 1; n=40) or 2 mL(0.5 mg) fenoterol added to 2 mL of 3 percent saline solution(group 2; n=40). This therapy was repeated at six hours interval after admission. They were evaluated daily just before and 20 minutes after nebulization. The outcome measures included changes in clinical severity score(based on respiratory rate, presence of wheezing, retraction, and general condition) after nebulization and duration of hospitalization. Results : In the clinical severity score, a significant improvement was observed during the 72 hours of hospitalization in both groups(P<0.05). The basic clinical severity scores before inhalation were decreased significantly faster in group 2 as compared to group 1 on each day of treatment(P<0.05). The mean duration of hospital stay was significantly reduced in group 2 than group 1($5.9{\pm}1.9days$ versus $7.4{\pm}2.0days$, P<0.05). No adverse effects were associated with inhaled therapy. Conclusion : These results suggest that a nebulized 3 percent saline solution plus 0.5 mg fenoterol may be more effective than a 0.9 percent saline solution plus 0.5 mg fenoterol in accelerating the clinical recovery of infants with viral bronchiolitis.

NEW ANTIDEPRESSANTS IN CHILD AND ADOLESCENT PSYCHIATRY (소아청소년정신과영역의 새로운 항우울제)

  • Lee, Soo-Jung
    • Journal of the Korean Academy of Child and Adolescent Psychiatry
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    • v.14 no.1
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    • pp.12-25
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    • 2003
  • Objectives:As increasing number of new antidepressants have been being introduced in clinical practice, pharmacological understanding has been broadened. These changes mandate new information and theories to be incorporated into the treatment process of children with depressive disorders. In light of newly coming knowledge, this review intended to recapitulate the characteristics of new antidepressants and to consider the pivotal issues to develope guidelines for the treatment of depression in childhood and adolescence. Methods:Searching the Pub-Med online database for the articles with the key words of 'new', 'antidepressants' and 'children' ninety-seven headings of review articles were obtained. The author selected the articles of pertinent subjects in terms of either treatment guideline or psychopharmacology of new antidepressants. When required, articles about the clinical effectiveness of individual antidepressants were separatedly searched. In addition, the safety information of new antidepressants was acquired by browsing the official sites of the United States Food and Drugs Administration and Department of Health and Human Services. Results:1) For the clinical course, treatment phase, and treatment outcome, the reviews or treatment guidelines adopted the information from adult treatment guidelines. 2) Systematic and critical reviews unambiguously concluded that selective serotonin reuptake inhibitors(SSRIs) excelled tricyclic antidepressants( TCAs) for both efficacy and side effect profiles, and were recommend for the first-line choice for the treatment of children with depressive disorders. 3) New antidepressants generally lacked treatment experiences and randomized controlled clinical trials. 4) SSRIs and other new antidepressants, when used together, might result in pharmacokinetic and/or pharmacodynamic drug-to-drug interaction. 5) The difference of the clinical effectiveness of antidepressants between children and adults should be addressed from developmental aspects, which required further evidence. Conclusion:Treatment guidelines for the pharmacological treatment of childhood and adolescence depression could be constructed on the basis of clinical trial findings and practical experiences. Treatment guidelines are to best serve as the frame of reference for a clinician to make reasonable decisions for a particular therapeutic situation. In order to fulfill this role, guidelines should be updated as soon as new research data become available.

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