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

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Adjuvant Sertraline Treatment for Chronic Schizophrenia : A Randomized, Double Blind, Placebo-Controlled Study (만성 정신분열증환자에 대한 Sertraline병합치료 효과)

  • Lee, Min-Soo;Kim, Yong-Ku;Lee, Sang-Kyu;Suh, Kwang-Yoon
    • Korean Journal of Biological Psychiatry
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    • v.4 no.1
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    • pp.127-131
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    • 1997
  • Objective : To evaluate the clinical efficacy of adjuvant sertraline treatment in chronic schizophrenic patients, we carried out a double-blind, placebo controlled study. Method : Thirty six inpatients who fulfilled DSM-III-R criteria for chronic schizophrenia were randomly assigned to sertraline and placebo groups in a double-blinded fashion. A history of at least 2 years of illness and at least six months of hospitalization were prerequisities for inclusion in the study. Patients were received sertraline 50mg or placebo for 8 weeks in addition to their routine haloperidol regimen. Positive and Negative Syndrome Scale (PANSS), Clinical Global Impression(CGI), Simpson-Angus Scale(S-A) were evaluated at 5 points ; baseline, 2, 4, 6, and 8 weeks of treatment. Results : The groups were controlled for age, gender, and length of illness. There were no significant differences in three PANSS factros(positive, negative, general), CGI, and S-A scale scores at any between sertaline and placebo treatment. Conclusion : This placebo controlled study showed no significant effects of sertraline on negative and positive symptoms in chronic schizophrenic patients.

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Effectiveness of a Yeonkyopaedok-san Extract in the Treatment of The Common Cold : Results of a Community-based, Double Blind, Randomized Placebo Controlled Trial (감기에 대한 연교패독산의 유효성 평가를 위한 community-based 이중맹검 위약 대조군 연구)

  • Bae, Han-Ho;Kang, Wee-Chang;Park, Yang-Chun
    • Journal of Physiology & Pathology in Korean Medicine
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    • v.22 no.1
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    • pp.234-245
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    • 2008
  • Yeonkyopaedok-san(YPS) extract is widely used to treat the common cold. The purpose of this study was to evaluate the efficacy of YPS on the common cold. Two hundred Patients with common colds of recent onset were randomized to the double blind, placebo-controlled study. They received 800 mg YPS extract or placebo in capsules, orally dissolved 3 times a day for 7 days. The total symptom score was assessed by the physician, using a 5-point scale on start and finish. Resolution of cold symptoms based on subjective daily symptoms. Total symptom score was significantly decreased in YPS groups in comparison to that in placebo group (p=0.027). Headache (p=0.012), loss of appetite (p=0.037), eyeball discomfort (p=0.002) were more affected. Time to resolution of cold symptoms did not show significant effect (p=0.592). Adverse effects were less in the YPS group than placebo group (2% vs 3%). In this community-based, randomized controlled trial, YPS were effective in treating cold symptoms in college students.

The effects of pomegranate peel added bread on anthropometric measurements, metabolic and oxidative parameters in individuals with type 2 diabetes: a double-blind, randomized, placebo-controlled study

  • Ozlem Ozpak Akkus;Ugurcan Metin;Zeynep Camlik
    • Nutrition Research and Practice
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    • v.17 no.4
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    • pp.698-716
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    • 2023
  • BACKGROUND/OBJECTIVES: The aim of this study was to evaluate the sensory properties of antioxidant-rich bread made by adding pomegranate peels and their effects on anthropometric measurements and metabolic and oxidative parameters of individuals with type 2 diabetes after consumption. SUBJECTS/METHODS: This randomized, double-blind, placebo-controlled study was conducted with 22 individuals aged between 19 and 64 years who had been diagnosed with type 2 diabetes for at least 5 years, used only metformin, did not lose more than 10% of their body weight in the last 6 months, and had a body mass index of ≥ 25.0 kg/m2. While the study group (n = 11) consumed bread containing 500 mg pomegranate peel daily for 8 wk, the control group (n = 11) consumed standard bread. Anthropometric measurements and metabolic and oxidative parameters of individuals were evaluated at the beginning and end of the study. RESULTS: Decreases were detected in the waist circumference, waist/hip and waist/height ratios, body fat percentages, blood pressure, and serum insulin, triglyceride, and total cholesterol levels in the individuals in the treatment group, compared with those in the control group (P < 0.05). CONCLUSIONS: Pomegranate peel consumption by individuals with type 2 diabetes may have positive effects on anthropometric measurements and glycemic and lipid parameters.

Effect of onion peel extract supplementation on the lipid profile and antioxidative status of healthy young women: a randomized, placebo-controlled, double-blind, crossover trial

  • Kim, Jungmi;Cha, Yong-Jun;Lee, Kyung-Hea;Park, Eunju
    • Nutrition Research and Practice
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    • v.7 no.5
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    • pp.373-379
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    • 2013
  • The consumption of fruits and vegetables that have high polyphenol content has been previously associated with a reduced risk for cardiovascular disease. We investigated the effects of onion peel extract on plasma total antioxidant capacity, lipid peroxidation, and leukocyte DNA damage. This study was a randomized, double-blind, placebo-controlled, crossover trial. Healthy female subjects received either onion peel extract or placebo (dextrin) for two weeks, underwent a 1-week washout period, and then received the other treatment for an additional two weeks. After two weeks of onion peel extract supplementation, the total cholesterol level, low-density lipoprotein cholesterol level, and atherogenic index significantly decreased (P < 0.05). No changes were observed in activities of erythrocyte antioxidant enzymes or levels of lipid peroxidation markers following onion peel extract supplementation. Additionally, no significant difference was found in plasma antioxidant vitamin (retinol, tocopherols, carotenoids, and coenzyme Q10) levels or ex vivo $H_2O_2$-provoked oxidative DNA damage after onion peel extract supplementation. The present interventional study provides evidence of the health benefits of onion peel extract and demonstrates its effects in modulating lipid profiles in healthy young Korean women.

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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Effects of Ephedra on the State-Trait Anxiety in Female Adults: A Double-Blind Randomized Controlled Study (마황복용이 성인여성의 상태-특성 불안에 미치는 영향: 무작위배정 이중맹검 임상연구)

  • Yang, Chang-Sop;Hsing, Li-Chang;Jeong, Hyun-Suk;Kim, Lak-Hyung;Kwak, Min-Jung;Seo, Eui-Seok;Jang, In-Soo
    • The Journal of Internal Korean Medicine
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    • v.28 no.2
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    • pp.346-353
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    • 2007
  • Background : Over a thousand years of clinical preparation of Ephedrain traditional Korean medicine has confirmed effectiveness and security. Recently. Ephedra-containing herbal preparations to treat obesity are common. The aim of this study is to identify effects of Ephedra on psychological anxiety. Objectives : To determine effects of Ephedraon psychoactivity and autonomic nervous system. Methods : The study design was a double-blind randomized controlled trial. The subjects of this study were healthy adults. They were allocated to either the Ephedragroup (N =66) or the placebo group (N =32), Ephedra(8 g) or a placebo in similar opaque capsules was given twice a day for 2 weeks. Anxiety score was estimated with State-Trait Anxiety Inventory before first and after last medication. 36 of the Ephedragroup and 24 of the placebo group finished the trial and were analyzed. Paired samples T-test and independent samples T-test were applied to statistical analysis. Results : The following result was obtained: After taking Ephedra. state anxiety increased significantly. In the placebo group. both state and trait anxiety increased although significance was not reached. Conclusions : It is concluded that the intake of Ephedraplays a significant role in the increase of anxiety in healthy adults. It is suggested that anxiety level change should be considered when using Ephedra in clinics.

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Clinical Trial of Taeeumjowui-Tang(Taiyintiaowei-tang) on Obese Patients - Randomized, Double Blind, Placebo-Controlled Study - (비만 환자에 대한 태음조위탕(太陰調胃湯) 임상연구 - 무작위배정, 이중맹검, 위약·대조군 임상시험 -)

  • Li, Ji-Eun;Song, Yun-Kyung;Lim, Hyung-Ho
    • Journal of Korean Medicine Rehabilitation
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    • v.20 no.4
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    • pp.197-213
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    • 2010
  • Objectives : The clinical trial was designed to investigate the safety and effects of Taeeumjowui-tang(Taiyintiaowei-tang) extracts on the change of the weight, body compositions, serum in obese patients. Methods : This was a 12-weeks, randomized, double blind, placebo-controlled clinical trial. Patients with a body mass index of either greater than $30kg/m^2$ or between 27 and $30kg/m^2$ with controlled hypertension, diabetes, hyperlipidemia were considered eligible. Participants of 41 obese patients were randomized either to Taeeumjowui-tang(Taiyintiaowei-tang)(23) or placebo(18). After 12 weeks of treatment, we measured anthropometric factors(weight, height, waist circumference, BMI(body mass index) etc.), abdominal fat area by CT(computed tomography)scanning, serum lipid(total cholesterol, tryglyceride, HDL-cholesterol, LDL-cholesterol), blood lever of variety(AST, ALT, BUN, creatinine etc.). Adverse events also evaluated. Results : After 12 weeks of treatment mean weight, waist-circumference, total cholesterol, LDL-cholesterol and score of KEAT-26 were significant changed in Taeeumjowui-tang(Taiyintiaowei-tang). There were no serious adverse events in either groups. Conclusions : There were limited in this study that is conducted within a short period of 12 weeks. but its weight and WC(waist circumference), WHR(waist hip ratio), total cholesterol, LDL-cholesterol and score of KEAT-26 loss effect was significant and it had few adverse events.

Effects of a Herbal Medicine, Yukgunja-Tang Extract Granule, on Functional Dyspepsia Patients by Sasang Constitution: Placebo-Controlled, Double-Blind, Randomized Trial (기능성 소화불량에 대한 육군자탕 엑스과립의 사상체질별 치료효과: 위약 대조, 이중 맹검, 무작위 시험)

  • Jeon, Su-Hyeong;Kim, Jong-Won
    • Journal of Sasang Constitutional Medicine
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    • v.30 no.2
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    • pp.42-54
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    • 2018
  • Objectives This study was aimed to compare effects of Yukgunja-tang (YGJT) extract granule on functional dyspepsia (FD) by sasang constitution. Methods A placebo-controlled, double-blind, randomized, two-center trial was performed. We obtained 3D face images of FD patients participating in this study using face-only scanner and classified them into two types as narrow face and wide face by 3D facial shape diagnosis system (3-FSDS). 96 subjects (48 subjects per type) were enrolled and were randomly allocated into treatment or control groups in a 2:1 ratio. YGJT extract granule or placebo were administered to each group during the 8 week treatment period. One of sasang constitutional specialist diagnosed their constitutions by referring to questionnaires and 3D face images. The primary outcome was total dyspepsia symptom scale (TDS scale), the secondary outcomes were single dyspepsia symptom scale (SDS scale), visual analog scale (VAS) and so on. This trial was registered with clinical research information service identifier: KCT0001920, 15 May, 2016. Results In the Taeeumin treatment group, the TDS scale was significantly decreased after 8 weeks compared to the control group (t=2.331, p=0.025) and the SDS scale also significantly decreased. (t=2.042, p=0.048). The specific effects of the YGJT extract granule without the placebo effect on the Taeeumin with functional dyspepsia were 30.61% in TDS scale and 28.33% in SDS scale. Conclusions The effects of Yukgunja-tang extract granule on functional dyspepsia was different according to Sasang constitution. So the constitution should be considered in randomized controlled trials using herbal extract granules.

Low-dose intravenous ketamine versus intravenous ketorolac in pain control in patients with acute renal colic in an emergency setting: a double-blind randomized clinical trial

  • Sotoodehnia, Mehran;Farmahini-Farahani, Mozhgan;Safaie, Arash;Rasooli, Fatemeh;Baratloo, Alireza
    • The Korean Journal of Pain
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    • v.32 no.2
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    • pp.97-104
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    • 2019
  • Background: This study was conducted to compare the effectiveness of low-dose ketamine versus ketorolac in pain control in patients with acute renal colic presenting to the emergency department (ED). Methods: This is a double-blind randomized clinical trial. The initial pain severity was assessed using the numerical rating scale (NRS). Then, ketamine or ketorolac was administered intravenously at a dose of 0.6 mg/kg and 30 mg respectively. The pain severity and adverse drug reactions were recorded 5, 15, 30, 60, and 120 min thereafter. Results: The data of 62 subjects in the ketamine group and 64 patients in the ketorolac group were analyzed. The mean age of the patients was $34.2{\pm}9.9$ and $37.9{\pm}10.6\;years$ in the ketamine and ketorolac group, respectively. There was no significant difference in the mean NRS scores at each time point, except for the 5 min, between the two groups. Despite a marked decrease in pain severity in the ketamine group from drug administration at the 5 min, a slight increase in pain was observed from the 5 min to the 15 min. The rate of adverse drug reactions, including dizziness (P = 0.001), agitation (P = 0.002), increased systolic blood pressure (> 140 mmHg), and diastolic blood pressure (> 90 mmHg) was higher in the ketamine group. Conclusions: Low dose ketamine is as effective as ketorolac in pain management in patients with renal colic presenting to the ED. However, it is associated with a higher rate of adverse drug reactions.