• Title/Summary/Keyword: double-blind

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Effect of Korean Red Ginseng in individuals exposed to high stress levels: a 6-week, double-blind, randomized, placebo-controlled trial

  • Baek, Ji Hyun;Heo, Jung-Yoon;Fava, Maurizio;Mischoulon, David;Choi, Kwan Woo;Na, Eun Jin;Cho, Hana;Jeon, Hong Jin
    • Journal of Ginseng Research
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    • v.43 no.3
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    • pp.402-407
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    • 2019
  • Background: To investigate the neurobiological evidence supporting the adaptogenic effects of Korean Red Ginseng in reducing the harmful consequences of stress using a double-blind, placebo-controlled trial. Method: Sixty-three subjects with high stress levels were randomized to receive an orally administered, double-blind, 6-week treatment with Korean Red Ginseng (n = 32) or placebo (n = 31). All participants underwent a comprehensive psychological evaluation using Beck Depression Inventory and Stress Response Inventory, cognitive evaluation using the continuous performance test, biological evaluation by measuring blood levels of lipids, catecholamines, inflammation markers, and heart rate variability at baseline and after 6 weeks. Results: At baseline, both groups showed no significant differences in age, sex, years of education, Beck Depression Inventory, and Stress Response Inventory. After 6 weeks, triglyceride levels were significantly increased within the normal limit in the Korean Red Ginseng group (F = 4.11, p = 0.048), and the epinephrine level was decreased in this group (F = 4,35, p = 0.043). The triglyceride increase was significantly associated with epinephrine decrease (B = 0.087, p = 0.041), suggesting that Korean Red Ginseng may stabilize the sympathetic nervous system. In addition, we detected a significant group by time effect in the visually controlled continuous performance test, suggesting positive effects of Korean Red Ginseng on cognition. Conclusion: Korean Red Ginseng might help to stabilize the sympathetic nervous system and improve cognition in individuals with high stress.

Efficacy and safety of low dose oral ketamine for controlling pain and distress during intravenous cannulation in children: a double-blind, randomized, placebo-controlled trial

  • Bagheri, Mahdi;Soltani, Alireza Ebrahim;Qorbani, Mostafa;Sureda, Antoni;Faghihi, Toktam
    • The Korean Journal of Pain
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    • v.35 no.3
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    • pp.311-318
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    • 2022
  • Background: Ketamine is widely used in infants and young children for procedural sedation and anesthesia. The aim of this study was to evaluate the efficacy and safety of low dose oral ketamine to control pain and distress in children during intravenous (IV) cannulation. Methods: This is a prospective, randomized, double-blind study, including children aged between 3 and 6 years requiring a non-emergent IV-line placement. Children were randomly assigned to two groups, treated either with oral ketamine or a placebo. All patients were monitored for vital signs. Pain was assessed using the Children's Hospital of Eastern Ontario Pain Scale (CHEOPS) and Wong-Baker Faces Pain Rating Scale (WBFS) scales and sedation using a 5-point sedation score. The facility of IV-line placement was measured by a 3-point scale. Adverse effects were recorded after 1 and 24 hours. Results: A total of 79 and 81 children were entered in the ketamine and placebo groups, respectively. The heart and respiratory rates increased significantly in the placebo group. The median CHEOPS 4 (95% confidence interval [CI]: 3, 4, P < 0.001) and WBFS 6 (95% CI: 4, 6, P < 0.001) scores decreased statistically in the ketamine group. IV-line placement was 50% easier in the ketamine group (95% CI: 37%, 63%, P < 0.001). No serious adverse effects were observed in all cases. Conclusions: Low dose oral ketamine effectively decreased the pain and distress during IV cannulation in children without any significant adverse reactions.

Randomized Controlled Double Blind Study of Bee Venom Therapy on Rheumatoid Arthritis (무작위 대조 이중맹검 시험을 통한 봉독 약침의 류마티스 관절염 치료 효과 연구)

  • Lee, Sang-hoon;Hong, Seung-jae;Kim, Su-young;Yang, Hyung-in;Lee, Jae-dong;Choi, Do-young;Lee, Doo-ik;Lee, Yun-ho
    • Journal of Acupuncture Research
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    • v.20 no.6
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    • pp.80-88
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    • 2003
  • Objective : This study was performed in order to evaluate the effect of bee venom therapy on rheumatoid arthritis by randomized controlled double blind method. Methods : RA patients were recruited and divided into an experiment group and a control group by random selection. As a double blind test, the experiment group was treated with bee venom injection on acupoints, and the control group was treated with normal saline injection on acupoints twice a week for 8 weeks. Tender joint count, swollen joint count, morning stiffness, pain, health assessment questionnaire, ESR, and CRP were estimated and analyzed at baseline, and at 1 month and 2 months after bee venom therapy. Results : Compared to the control group, the experiment group showed significant decrease in tender joint count, swollen joint count, morning stiffness, and health assessment questionnaire after 2 months. Pain, ESR and CRP showed significant decrease in the experiment group after 1 & 2 months. Conclusions : These results suggests that bee venom therapy could be an effective method in the treatment of patients with rheumatoid arthritis.

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A Experiment Study on Performance Evaluation of Solar Heat Gain Coefficient in Glazing with Shading Devices (실내 차양장치 결합형 창호의 태양열 취득률 평가에 대한 실험적 연구)

  • Kim, Tae-Jung;Kang, Jae-Sik;Park, Jun-Seok
    • Journal of the Korean Solar Energy Society
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    • v.34 no.5
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    • pp.89-99
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    • 2014
  • The determination of the solar and thermal performance of fenestration is required for the evaluation of fenestration energy performance, estimating building load. Presently, there exist several methods for determining the thermal transmission(U-value) and solar heat gain coefficient (SHGC) of fenestration system. These method are commonly grouped under calculation or experimental methods. While U-value testing and calculation methods have been long established, SHGC has been evaluated only by the method of calculation under the lack of any established testing method. However, it is difficult to assess the exact SHGC for various types of fenestration with sun-shading or other solar control systems. The purpose of this study was to evaluate the effect of interior venetian blind and roll screen on the SHGC of glazing system. SHGC has been evaluated by the KS L 9107 test method and exiting calculation method for precise comparison of the energy performances of various shading devices. In this research, the test sample consists of three different types of double glazing unit with venetian blind and roll screen. Slat angles of venetian blind were changed to $-45^{\circ}$, $0^{\circ}$, and$-45^{\circ}$. For the roll screen, measurements were taken with the roll screen in the closed position. In result, the venetian blind reduced SHGC by 21.2~28.4% at $45^{\circ}$, when compared to the double glazing unit. The roll screen reduced SHGC by 34.4~41.7% at closed. The differences between the measured and calculated SHGC were found to range between 0.001(0.2%) and 0.047(11.1%) for all test cases. For the cases of venetian blind $-45^{\circ}$, $0^{\circ}$ and $45^{\circ}$, the deviation ratio were 3.6~9.8%, 1.1~2.6%, 4.2~11.1%, respectively. For the case of roll screen, the deviation ratio were 4.1~5.7%.

Comparison of Two pMDIs in Adult Asthmatics: A Randomized Double-Blind Double-Dummy Clinical Trial

  • Nam, Tae-Hyun;Kang, Sung-Yoon;Lee, Sang Min;Kim, Tae-Bum;Lee, Sang Pyo
    • Tuberculosis and Respiratory Diseases
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    • v.85 no.1
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    • pp.25-36
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    • 2022
  • Background: Only a few studies directly compared the therapeutic efficacy and safety of two pressurized metered-dose inhalers (pMDIs) in asthma. We analyzed the asthma treatment outcomes, safety, and patient preferences using formoterol/beclomethasone (FORM/BDP), a pMDI with extra-fine particles, compared with formoterol/budesonide (FORM/BUD), another pMDI with non-extra-fine particles. Methods: In this randomized, double-blind, double-dummy parallel group study, 40 adult asthmatics were randomized to FORM/BDP group (n=18; active FORM/BDP and placebo FORM/BUD) or FORM/BUD group (n=22; active FORM/BUD and placebo FORM/BDP). During the two visits (baseline and end of 8-week treatment), subjects were asked to answer questionnaires including asthma control test (ACT), asthma control questionnaires (ACQ), and Quality of Life Questionnaire for Adult Korean Asthmatics (QLQAKA). Lung function, compliance with inhaler, and inhaler-handling skills were also assessed. Results: Ten subjects in the FORM/BDP group and 14 in the FORM/BUD group completed follow-up visits. ACT, ACQ, QLQAKA (a primary outcome), and adverse events did not differ between two groups. We found that the increase in forced expiratory volume in 1 second/forced vital capacity and forced expiratory flow at 25% to 75% of the pulmonary volume in the FORM/BDP group was higher than in the FORM/BUD group. Regarding preference, subjects responded that the flume velocity of FORM/BDP was higher, but more adequate than that of FORM/BUD. They also answered that FORM/BDP reached the trachea and bronchus and irritated them significantly more than FORM/BUD. Conclusion: The use of pMDI with extra-fine particles may relieve small airway obstruction more than the one with non-extra-fine particles despite no significant differences in overall treatment outcomes. Some asthmatics have a misconception about the adequacy of high flume velocity of pMDIs.

CLINICAL EFFECTS OF GINSENG PREPARATION

  • Sandberg Finn
    • Proceedings of the Ginseng society Conference
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    • 1974.09a
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    • pp.65-67
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    • 1974
  • In a double-blind test performed for 33-days on healthy students 2 capsules daily of Geriatric Pharmaton (ginsengextractvitamins and diethylaminoethanol) and of Gerikomplex Vitamex (ginsengextract viatmins but no diethylaminoethanol) showed a significant positive effect on psychomotor activity and simultaneous capacity. With the two methods used no difference between the prerarations could be demonstrated.

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EVALUATION OF THE THERAPEUTIC EFFECTS OF CARBAMAZEPINE IN AUTISTIC CHILDREN (자폐증 아동에 있어서 Carbamazepine의 치료효과 평가)

  • Hong, Kang-E;Choi, Jin-Sook;Shin, Min-Sup;Hwang, Yong-Seung;Ahn, Yun-Ok
    • Journal of the Korean Academy of Child and Adolescent Psychiatry
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    • v.2 no.1
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    • pp.87-96
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    • 1991
  • A double bhad, placebo controlled study was performed to evaluate the therapeutic effects of Carbamazepine in autistic children, 23 boys with the diagnosis of Pervasive Developmental Disorders according to the DSM-IIIR were selected for study subjects, from Child and Adolescent Psychiatric Outpatient Department of Seoul National University Children Hospital during Oct. $1989{\sim}Nov.$ 1991. Subjects with histories of medical disease or psychiatric diseases were excluded and all study subjects had drug free periods more than 2 Months. Study subjects were randomly assigned to Cabamazepine treatment group(N=12) and placebo group(N=11). After the baseline observation periods, the double blind drug treatment and observation were performed for 12 weeks. Several scales (Ritvo-Freedman Real Life atring Scale. Behavior Checklist) were employed to evaluate the effects of drug treatment during baseline observation periods and the drug treatment periods by two raters blind to the study. Interrater reliability of each scales were .4875~.6613, the socrodemographic variables and the rating scores during baseline observation periods were not significantly different between two groups. Reduction of total scores in Autsm Behavior Checklist scale, i.e.. improvement of global autistic symptoms were noted significantly in Carbamazepine treatment group. Improvement in significant social maturations according to Vineland Social Mataration scale were observed in both patient groups after drug treetment periods.

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Double-blind Comparative Trial of Fluoxetine and Amitriptyline in Major Depression (주요우울증에서 Fluoxetine과 Amitriptyline의 치료효과에 대한 이중맹검법 비교연구)

  • Jung, Hee-Yeon;Bae, Jae-Nam;Kwon, Jun-Soo;Cho, Doo-Young
    • Korean Journal of Psychosomatic Medicine
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    • v.3 no.1
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    • pp.11-18
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    • 1995
  • The efficacy of fluoxetine was evaluated in 32 patients with major depression in double-blind amitriptyline-controlled clinical trials. Patients were randomly assigned to 6 weeks of treatment with 20mg/day of fluoxetine and 25-100mg/day of amitriptyline. We used the Hamilton rating scale for depression(HAM-D) and the Clinical Global Improvement(CGI) to evaluate the improvement of depression. In addition, we also used the Covi Anxiety Scale and the Anxiety/Somatization subscale of HAM-D to investigate the relieving effect of anxiety. The improvement by fluoxetine in mean total score of HAM-D and CGI was comparable to amitriptyline. Fluoxetine also reduced anxiety significantly, but there was no difference between fluoxetine and amitriptyline in relieving anxiety symptoms. Fluoxetine showed considerably less adverse effects, especially anticholinergic effect and weight gain than amitriptyline. In conclusion, 20mg/day of fluoxetine was sufficiently effective in the treatment of depressive patients and was better tolerated than amitriptyline.

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