• Title/Summary/Keyword: double blind test

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합성의약품으로 호전되지 않은 소화기 증상 환자(KCD K-코드)에 대한 반하사심탕 제제 병용의 효과 : 후향적 차트 분석 (Effectiveness of Additional Administration of a Banha-sasim-tang Formulation to Patients with Gastrointestinal Symptoms (KCD K-code) Not Improved by Western Medicines: A Retrospective Chart Review)

  • 김철현;김광호;이영웅;강선이;강건희
    • 대한한방내과학회지
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    • 제42권6호
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    • pp.1349-1355
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    • 2021
  • Objectives: The aim of this study was to evaluate the effectiveness of additional administration of Banha-sasim-tang formulation to patients with gastrointestinal symptoms that did not improve with Western medicines. Methods: The patients who met the inclusion and exclusion criteria were analyzed retrospectively. A paired t-test was performed on the Nepean Dyspepsia Index-Korean version (NDI-K) scores before and after administering the Banha-sasim-tang formulation. Results: A total of 27 subjects were included. The mean duration of taking the Banha-sasim-tang formulation was 15.6±3.1 days. The most commonly used Western medicine before taking the Banha-sasim-tang formulation was rebamipide. The means of the NDI-K score were 57.4±21.8 before administering Banha-sasim-tang formulation and 34.9±16.5 after administration, and the difference was statistically significant (p<0.0001). No serious side effects were encountered while taking the Banha-sasim-tang formulation. Conclusions: For patients whose gastrointestinal symptoms do not improve with Western medicines, additional administration of Banha-sasim-tang formulation may be an option. However, as this study is a retrospective chart review, prospective, large-scale, double-blind studies are needed in the future.

Efficacy and Safety of Cheong-A-Won Gagambang (JCE003) on Knee Osteoarthritis: Randomized Controlled Pilot Trial

  • Kong, Haejin;Kang, Jaehui;Lee, Hyun
    • Journal of Acupuncture Research
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    • 제39권3호
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    • pp.202-212
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    • 2022
  • Background: The aim of this study was to evaluate the effectiveness and safety of Cheong-A-Won Gagambang (JCE003) treatment for degenerative knee osteoarthritis. Methods: This was a single-center, randomized, double-blind, placebo-controlled pilot clinical trial. There were 36 adults with degenerative knee osteoarthritis who were randomly allocated into JCE003 1,000 mg, JCE003 2,000 mg, or the placebo group (in a 1:1:1 ratio). The participants received 12 weeks of treatment and had scheduled tests every 6 weeks. The primary outcomes were measured using the Korean Western Ontario and McMaster Universities scale, and the secondary outcomes were measured using the visual analog scale, European quality of life-5-dimensions, patient global impression of change, C-reactive protein, and erythrocyte sedimentation rate. Changes between baseline scores and scores following study completion were analyzed. Results: There were 29 participants whose data were analyzed in this study. The change of Korean Western Ontario and McMaster Universities, visual analog scale, European quality of life-5-dimensions scores showed significant improvement in the JCE003 1,000 mg group. The change of patient global impression of change was significantly improved in the placebo group. There were 14 adverse events, but there was no clinically significant relationship with the intake of JCE003 compared with the placebo. Conclusion: Taking JCE003 may be effective at improving knee pain in patients with degenerative knee osteoarthritis and appears to be safe. Based on this study, the concentration and feasibility of the test group may be used when conducting a large-scale clinical trial of degenerative knee osteoarthritis in the future.

주정중독에 동반된 우울증의 치료에서 Paroxetine과 Amitriptyline의 이중맹 비교 : 치료초기 2주 동안의 행동학적 부작용 (A Double-Blind Comparison of Paroxetine and Amitriptyline in the Treatment of Depression Accompanied by Alcoholism : Behavioral Side Effects during the First 2 Weeks of Treatment)

  • 윤진상;윤보현;최태석;김용범;이형영
    • 생물정신의학
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    • 제3권2호
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    • pp.277-287
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    • 1996
  • 본 연구는 주정중독에 동반된 우울증 환자의 치료에서 적어도 행동학적 부작용의 관점에서는 PAR이 AMI보다 우수함을 증명하였다. 이러한 PAR의 행동학적 효과의 우수성은 환자의 삶의 질을 향상시키고 결국 치료결과를 높이는데 관여하리라고 생각된다.

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염화 세틸피리디늄 분말의 치태제거와 치은염 완화 효과에 관한 임상시험 (Effect of Cetylpyridinium Chloride on Gingival Inflammation and Plaque Accumulation)

  • 전형식;고영경;구영;류인철;최상목;정종평
    • Journal of Periodontal and Implant Science
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    • 제29권1호
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    • pp.141-151
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    • 1999
  • To evaluate the effect of cetylpyridinium chloride in a powder form when used concomitantly with a commercial flouride containing tooth paste on inhibition of plaque formation, on gingivitis, and on irritation of oral mucosa, a double--blind, randomized parallel study was set up. Cetylpyridinium chloride was incorporated into a ligh brown colored powder with menthol added for scent. There were no diffemces between the active agent and the placebo which did not contain cetylpyridinium chloride in appearance, color, smell, taste, or dispenser. 98 healthy volunteers were assigned to one of two groups: brushing 3 times a day with flouride toothpaste and cetylpyridinium chloride powder, or brushing 3 times a day with flouride toothpaste and placebo. Before the test period, the subjects received through tooth cleaning and polishing. At basteline, GI, PI, BOP, and GCF of the Ramfjord teeth were measured in the experimental and placebo groups including 58 and 42 subjects repectively, After 4 weeks, GI, PI, BOP, GCF, compliance, irritation of the oral mucosa(redness, pus drainage, edema) and adverse reactions were measured. The PI, GI, and BOP of the experimental group recorded at baseline are 0.19${\pm}$0.19, 0.42${\pm}$0.31, and 0.08${\pm}$0.15. These scores showed significant decrease after 4 weeks of test period(0.11${\pm}$0.15, 0.22${\pm}$0.24, 0.02${\pm}$0.09 repectively at the end of the study) and inhibition of plaque accumulation and resolution of gingival inflammation could be observed. GCF shoed slight increase but this was not statistically different. Comparison of changes in measured scores of control and experimental groupshow GI, PI of the test indices have decreased. Test group showed significantly greater decrease in gingivitis and plaque accumulation after 4 weeks. GCF and BOP also showed greater decrease thant the control group but this difference was not statistically significant. At no time of the study period did any of the subjects show signs of irritation of the oral mucosa or adverse reactions. Following conclusions could be obtained from this study. The combined use of cetl powder and flouride toothpaste showed greater inhibition of plaque accumulation and greater decrease of gingivitis than use of flouride toothpaste with placebo agent.

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The Effects of Combination of Functional Beverage(Garcinia Cambogia, L-Carnitine, and Soy Peptide) and Exercise on the Improvement of Body Fat

  • Kim, Kyung-Soo;Jung, Ju-Hae;Song, Chan-Hee;Sung, Bong-Ju
    • Biomolecules & Therapeutics
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    • 제11권2호
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    • pp.99-108
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    • 2003
  • Background: There is abundance of studies on the decrease in body fat through limited calorie intake or exercise; however, studies focusing simultaneously on functional foods and exercise are rare. This study was aimed to identify the effects of combination of a functional beverage and exercise on body composition and biochemical metabolic profiles. Method: Eighty-one healthy volunteers (69 females aged 19 to 50 years and 12 males aged 19 to 55 years), who maintained their body weight stable with 23 or higher in BMI (kg/$m^2$) and 25% or higher body fat for the last three months, were recruited in the study through written advertisement. All the subjects gave their informed consent, and the study was conducted in accordance with the Declaration of Helsinki. The study design was a randomized double-blind placebo-controlled parallel group design. All participants were given 12-week programed-exercise, which was performed 3 times a week. One bottle (100 ml) of test (Garcinia cambogia 300 mg, L-carnitine 20 mg, Soy peptide 1,000 mg) or placebo solution was given daily 30 min before each session of programed-exercise. BMI (body mass index), %fat, local fat amount (visceral and mid-thigh), waist circumference, skin fold thickness and some biochemical metabolic parameters like glucose, insulin and free fatty acids, etc in the blood were measured and compared before and after 12-week intervention within groups as well as between groups according to the protocol Results: Twenty six volunteers were dropped out and fifty five volunteers completed the study. At the end of 4, 8, and 12 weeks, approximately 1.98%, 3.00% and 3.50% losses of initial body weight were observed, respectively, in the test group (P<0.01), and 0.29, % ,0.74%, 1.60%, respectively, in the placebo group (P>0.05). BMI changed by 2.40%, 3.41% and 4.46%, respectively, in the test group, and 0.38%, 0.95% and 1.75%, respectively, in the placebo group, at each period of time. The reductions of body weight and BMI were significantly higher in the test group than in the placebo group at each period of time (P<0.05). Conclusions: It is thought that the combination of functional beverage, which contains mostly garcinia cambogia, L-carnitine, and soy peptide, and exercise have synergy effects on reducing body fat.

Coconut-derived D-xylose affects postprandial glucose and insulin responses in healthy individuals

  • Yun, Jung-Bae;Bak, Youn-Kyung;Kim, Bum-Sik;Kim, Min-Sun;Lee, Jin-Hee;Sung, Mi-Kyung
    • Nutrition Research and Practice
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    • 제5권6호
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    • pp.533-539
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    • 2011
  • Metabolic alterations including postprandial hyperglycemia have been implicated in the development of obesity-related diseases. Xylose is a sucrase inhibitor suggested to suppress the postprandial glucose surge. The objectives of this study were to assess the inhibitory effects of two different concentrations of xylose on postprandial glucose and insulin responses and to evaluate its efficacy in the presence of other macronutrients. Randomized double-blind cross-over studies were conducted to examine the effect of D-xylose on postprandial glucose and insulin response following the oral glucose tolerance test (OGTT). In study 1, the overnight-fasted study subjects (n = 49) consumed a test sucrose solution (50 g sucrose in 130 ml water) containing 0, 5, or 7.5 g D-xylose powder. In study 2, the overnight-fasted study subjects (n = 50) consumed a test meal (50 g sucrose in a 60 g muffin and 200 ml sucrose-containing solution). The control meal provided 64.5 g of carbohydrates, 4.5 g of fat, and 10 g of protein. The xylose meal was identical to the control meal except 5 g of xylose was added to the muffin mix. In study 1, the 5 g xylose-containing solutions exhibited significantly lower area under the glucose curve (AUCg) and area under the insulin curve (AUCi) values for 0-15 min (P < 0.0001, P < 0.0001), 0-30 min (P < 0.0001, P < 0.0001), 0-45 min (P < 0.0001, P < 0.0001), 0-60 min (P < 0.0001, P < 0.0001), 0-90 min (P < 0.0001, P < 0.0001) and 0-120 min (P = 0.0071, P = 0.0016). In study 2, the test meal exhibited significantly lower AUCg and AUCi values for 0-15 min (P < 0.0001, P < 0.0001), 0-30 min (P < 0.0001, P < 0.0001), 0-45 min (P < 0.0001, P = 0.0005), 0-60 min (P = 0.0002, P = 0.0025), and 0-90 min (P = 0.0396, P = 0.0246). In conclusion, xylose showed an acute suppressive effect on the postprandial glucose and insulin surges.

Addition of 2 mg dexamethasone to improve the anesthetic efficacy of 2% lidocaine with 1:80,000 epinephrine administered for inferior alveolar nerve block to patients with symptomatic irreversible pulpitis in the mandibular molars: a randomized double-blind clinical trial

  • Aggarwal, Vivek;Ahmad, Tanveer;Singla, Mamta;Gupta, Alpa;Saatchi, Masoud;Hasija, Mukesh;Meena, Babita;Kumar, Umesh
    • Journal of Dental Anesthesia and Pain Medicine
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    • 제22권4호
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    • pp.305-314
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    • 2022
  • Introduction: This clinical trial aimed to evaluate the anesthetic effect of the addition of 2 mg (4 mg/ml) of dexamethasone to 2% lidocaine (plain or with 1:80,000 epinephrine). The solutions were injected for a primary inferior alveolar nerve block (IANB) to provide mandibular anesthesia for the endodontic treatment of mandibular molars with symptomatic irreversible pulpitis. Methods: In a double-blinded setup, 124 patients randomly received either of the following injections: 2% lidocaine with 1:80,000 epinephrine, 2% lidocaine with 1:80,000 epinephrine mixed with 2 mg dexamethasone, or plain 2% lidocaine mixed with 2 mg dexamethasone, which were injected as a primary IANB. Ten minutes after injection, patients with profound lip numbness underwent electric and thermal pulp sensibility tests. Patients who responded positively to the tests were categorized as "failed" anesthesia and received supplemental anesthesia. The remaining patients underwent endodontic treatment using a rubber dam. Anesthetic success was defined as "no pain or faint/weak/mild pain" during endodontic access preparation and instrumentation (HP visual analog scale score < 55 mm). The effect of the anesthetic solutions on the maximum change in heart rate was also evaluated. The Pearson chi-square test at 5% and 1% significance was used to analyze anesthetic success rates. Results: The 2% lidocaine with 1:80,000 epinephrine, 2% lidocaine with 1:80,000 epinephrine mixed with 2 mg dexamethasone, and plain 2% lidocaine mixed with 2 mg dexamethasone groups had anesthetic success rates of 34%, 59%, and 29%, respectively. The addition of dexamethasone resulted in significantly better results (P < 0.001, 𝛘2 = 9.07, df = 2). Conclusions: The addition of dexamethasone to 2% lidocaine with epinephrine, administered as an IANB, can improve the anesthetic success rates during the endodontic management of symptomatic mandibular molars with irreversible pulpitis.

한의약소재 스포츠음료수 섭취가 운동-유발성 피로의 단시간 회복에 미치는 영향 (Effect of Oral Sport Beverages with Medicinal Herbs Added on Short-term Recovery from Exercise-induced Fatigue)

  • 나현종;이규락;강호율
    • 대한한의학회지
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    • 제27권1호
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    • pp.36-46
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    • 2006
  • Objectives : Ginseng Research Group in Korea Food Research Institute developed Saeng Mac San (KFRI-2)and Je Ho Tang (KFRI-3) with their sensory factors more acceptable. And we examined their effects on the short-term recovery capacity for cycling exercise (EX) maintained to all-out. Methods : Seven healthy young subjects (aged $24.0{\pm}2.1yr$) were volunteered at this double blind test. Each of KFRI-2, 3, a commercial sport beverage and control (CON) was offered randomly on a series of EX protocol including 65% VO2max-90min EX (D-ride). 1h-recovery and 85% VO2max EX to all-out (P-ride) under the control of their heart rate (HR) and rating perception of exertion (RPE). Blood samples were collected before D-ride, 30, 60 and 90min in D-ride, 30 and 60min in the recovery period and each 10min in P-ride. Plasma analysis items were glucose, insulin, cortisol (CORT), testosterone (TEST), free fatty acid (FFA), $Na^+$, Cl-and $K^+$. The collected data (Means${\pm}$SE) were analysed by two-way ANOVA and statistically significant differences between treatments (p<0.05) by LSD.; the significant level in FFA, $Na^+$, Cl-and $Na^+$ was p<0.01 Results : At 30min during recovery. plasma glucose level in KFRI-3 was significantly higher than CON, and also insulin in KFRI-3 was than CON and KFRI-2. FFA in KFRI-3 was significantly lower than CON during recovery. $Na^+$ in KFRI-3 significantly higher than CON at 90min in D-ride, and also KFRI-2 was at 60min during recovery. However CORT, TEST, Cl-and $Na^+$ in treated beverages were not significant. KFRI-2, 3 elevated the time for P-ride more than CON did. Conclusions : KFRI-2, 3 elevated the time for P-ride about 12% more than CON did. It is based on rapid recovery of plasma glucose level and inhibition of lipolysis during recovery.

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The Effect of CYP2D6/3A5 Genotypes on Plasma Concentrations of Haloperidol after Adjunctive Treatment of Aripiprazole

  • Shim, Joo-Cheol;Ahn, Jung-Mi;Jung, Do-Un;Kong, Bo-Geum;Kang, Jae-Wook;Liu, Kwang-Hyeon;Shin, Jae-Gook
    • 생물정신의학
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    • 제18권2호
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    • pp.95-100
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    • 2011
  • Objectives To evaluate the drug interactions between aripiprazole and haloperidol, authors investigated plasma concentrations of those drugs by genotypes. Method Fifty six patients with a confirmed Diagnostic and Statistical Manual of Mental Disorders 4th edition diagnosis of schizophrenia were enrolled in this eight-week, double blind, placebo-controlled study. Twenty-eight patients received adjunctive aripiprazole treatment and twenty-eight patients received placebo while being maintained on haloperidol treatment. Aripiprazole was dosed at 15 mg/day for the first 4 weeks, and then 30 mg for the next 4 weeks. The haloperidol dose remained fixed throughout the study. Plasma concentrations of haloperidol and aripiprazole were measured by high-performance liquid chromatography-tandem mass spectrometry (LC-MS/MS) at baseline, week 1, 2, 4 and 8. $^*1$, $^*5$, and $^*10$ B alleles of CYP2D6 and $^*1$ and $^*3$ alleles of CYP3A5 were determined. The Student's T-test, Pearson's Chi-square test, Wilcoxon Rank Sum test and Logistic Regression analysis were used for data analysis. All tests were two-tailed and significance was defined as an alpha < 0.05. Results In the frequency of CYP2D6 genotype, $^*1/^*10$ B type was most frequent (36.5%) and $^*1/^*1$ (30.8%), $^*10B/^*10B$ (17.3%) types followed. In the frequency of CYP3A5 genotype, $^*3/^*3$ type was found in 63.5% of subjects, and $^*1/^*3$ type and $^*1/^*1$ were 30.8% and 5.8% respectively. The plasma levels of haloperidol and its metabolites did not demonstrate significant time effects and time-group interactions after adjunctive treatment of aripiprazole. The genotypes of CYP2D6 and 3A5 did not affect the plasma concentration of haloperidol in this trial. No serious adverse event was found after adding aripiprazole to haloperidol. Conclusion No significant drug interaction was found between haloperidol and aripiprazole. Genotypes of CYP2D6 and 3A5 did not affect the concentration of haloperidol after adding aripiprazole.

칠제향부환(七製香附丸)이 원발성(原發性) 월경통(月經痛) 환자(患者)의 복부(腹部) 및 수장부(手掌部) 온도(手掌部 溫度)에 미치는 영향(影響) (The effect of Chiljehyangbuhwan on the abdomial & palmar temperature in the primary dysmenorrhea patients)

  • 이창훈;조정훈;장준복;이경섭;윤영진
    • 대한한방체열의학회지
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    • 제5권1호
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    • pp.46-58
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    • 2006
  • Purpose: We intended to observe the relations between Chiljehyangbuhwan and abdominal & palmar temperature according to primary dysmenorrhea severity. Methods: We selected the 100 primary dysmenorrhea patients by the screening tests (first screening test-inquiry, second screening test-clinical test. additionally WHR (Waist-to-Hip ratio) by Inbody 2.0). By the fixed blocked randomization and double blind method, Chiljehyangbuhwan or placebo was administered for 1 menstration period. Finally, 69 patients remainded. Before and after administration, we measured 4 points abdominal temperature (Chon-jung (CV17), Chung-wan(CV12), Kwan-won(CV4). Chung-guk(CV3)) by DITI(DOREX Inc., USA). And then we checked the difference of temperature $({\Delta}T)$ between CV17 and CV12/CV17 and CV4/CV17 and CV3/CV12 and CV4/CV12 and CV3. Also, we measured 2 points (palmar region, upper front of forearm) for the difference of palmar temperature $({\Delta}T)$. Then, we checked palmar temperature minus upper front of forearm temperature and took an average of right and left ${\Delta}T.$ After that. we compared ${\Delta}T$ with primary dysmenorrhea severity evaluated by VRS (verbal rating scale) and MVRS (multidimensional verbal rating scale). In dysmenorrhea severity. we standardized scale score and 3-group-severity by score (mild, moderate. severe). Besides, we compared palmar ${\Delta}T$ with abdominal ${\Delta}T$. For statistics, we used ANOVA and Spearman's rho correlations. SPSS 13.0 for windows. Results: In case of MVRS, though Chiljehyangbuhwan was correlated to abdominal ${\Delta}T$(CV12 and CV3/CV12 and CV4). it was not correlated to palmar ${\Delta}T$. In case of VRS, though Chiljehyangbuhwan was not correlated to abdominal ${\Delta}T$. it was correlated to palmar ${\Delta}T$. However. palmar ${\Delta}T$ was not correlated to abdominal ${\Delta}T$. Statistically they showed significant result (p<0.05). Conclusion: The primary dysmenorrhea patients showed that severity by MVRS was connected with abdominal ${\Delta}T$ (CV12 and CV3/CV12 and CV4) and severity by VRS was connected with palmar ${\Delta}T$ after Chiljehyangbuhwan administration. So we can consider Chiljehyangbuhwan partially effects the abdominal & palmar temperature according primary dysmenorrhea severity. However, palmar temperature was not correlated to abdominal temperature. Therefore, we need further study.

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