• 제목/요약/키워드: Double blind test

검색결과 145건 처리시간 0.03초

Effect of high-dose ginsenoside complex (UG0712) supplementation on physical performance of healthy adults during a 12-week supervised exercise program: A randomized placebo-controlled clinical trial

  • Lee, Eon Sook;Yang, Yun Jun;Lee, Jun Hyung;Yoon, Yeong Sook
    • Journal of Ginseng Research
    • /
    • 제42권2호
    • /
    • pp.192-198
    • /
    • 2018
  • Background: Ginseng has been used as an ergogenic agent, although evidence for its effectiveness is weak. A randomized, double-blind, placebo-controlled clinical trial was conducted to evaluate the effect of a ginsenoside complex (UG0712) on changes in exercise performance. Methods: Sedentary individuals (n = 117) were randomly assigned into one of three groups: low-dose ginsenoside supplementation (100 mg/d, n = 39), high-dose ginsenoside supplementation (500 mg/d, n = 39), or a placebo group (500 mg/d, n = 39). All participants underwent a supervised 12-wk aerobic and resistance exercise training course. To assess the effects of supplementation on physical performance, maximal oxygen consumption ($VO_2max$), anaerobic threshold (AT), lactic acid, and muscle strength of the dominant knee were measured at baseline, every visit, and after the training program. Results: Both ginsenoside groups showed significant increases in $VO_2max$ and muscular strength during exercise training. There were no definite changes in AT and lactic acid levels over time. After exercise training, there were definite differences in the $VO_2max$ (28.64.9 to $33.7{\pm}4.9ml/kg/min$ in high-dose group vs. $30.4{\pm}6.7$ to $32.8{\pm}6.6ml/kg/min$ in placebo, p = 0.029) and AT ($19.3{\pm}4.2$ to $20.9{\pm}3.5ml/kg/min$ in high-dose group vs. $20.0{\pm}5.1$ to $20.0{\pm}4.9ml/kg/min$ in placebo, p = 0.038) between the high-dose ginsenoside and placebo groups. However, there was no difference in $VO_2max$ between the low-dose ginsenoside and placebo groups (p = 0.254). There were no differences in muscular strength during exercise training among the three groups. Conclusion: High-dose ginsenoside supplementation (UG0712) augmented the improvement of aerobic capacity by exercise training.

Single buccal infiltration of high concentration lignocaine versus articaine in maxillary third molar surgery

  • Phyo, Hnin Ei;Chaiyasamut, Teeranut;Kiattavorncharoen, Sirichai;Pairuchvej, Verasak;Bhattarai, Bishwa Prakash;Wongsirichat, Natthamet
    • Journal of Dental Anesthesia and Pain Medicine
    • /
    • 제20권4호
    • /
    • pp.203-212
    • /
    • 2020
  • Background: This research evaluated the numbness produced by lignocaine at an equal or higher concentration than that of 4% articaine through a single point of injection for maxillary third molar surgery. This randomized double-blind study was conducted to compare the anesthetic efficiency of 4% lignocaine with that of 4% articaine in impacted maxillary third molar surgery using a single buccal infiltration alone. Methods: The study participants were 30 healthy patients requiring the bilateral surgical removal of symmetrically-positioned maxillary third molars. Using a split-mouth design, each patient randomly received buccal infiltration of 1.7 ml of 4% lignocaine and 1.7 ml of 4% articaine during two separate appointments. After 15 minutes of anesthetic injection, surgery was performed by the same surgeon using a consistent technique on both sides. Pinprick test pain scores of the buccal and palatal gingiva of the maxillary third molar after 10 minutes and 15 minutes latencies, pain scores during the surgery, the need for supplemental anesthesia, and patients' satisfaction with anesthetic efficiency were recorded. Surgery performed without supplemental anesthesia was categorized as successful. Results: The success rates of 4% lignocaine and 4% articaine (83.34% vs. 86.67%, P = 1.00) were not significantly different. Only 5 cases (4 cases in the articaine group and 1 case in the lignocaine group) reported mild pain and pressure sensation (NRS ≤ 1) on probing at the palatal side after 15 minutes of latency (P = 0.25). The pain scores of maxillary third molar surgery in the two groups were not significantly different (P > 0.05). Moreover, the statistical analysis confirmed the comparable patient satisfaction of two study groups (P = 0.284). Conclusion: This study provides evidence that single buccal infiltrations of 4% lignocaine and 4% articaine have comparable anesthetic efficacy and success rates for impacted maxillary third molar surgery. Both 4% lignocaine and 4% articaine can produce effective palatal anesthesia and pain control using buccal infiltration alone after 15 minutes of latency.

아토피 피부염 외용제에 관련된 국내 임상 및 실험 논문 고찰 (Review of Clinical and Experimental Studies on External Application Treatment for Atopic Dermatitis in the Korean Literature)

  • 민들레;박은정;강경하
    • 대한한방소아과학회지
    • /
    • 제27권1호
    • /
    • pp.36-49
    • /
    • 2013
  • Objectives The goal of this review is to investigate clinical and experimental studies on external application treatment for atopic dermatitis in Korean literature and to propose for the better method of clinical studies in order to seek more effective treatment. Methods Electronic researches were performed with KTKP, OASIS, National Assembly Library, Korean Medicine Database, KISS, DBpia, and KISTI. Results and Conclusions In Twenty six studies, the numbers of clinical and experimental studies are respectively 10 (38.46%) and 16 (61.54%). The numbers of studies that used herbal complex were 20 (76.92%), and out of that, 6 studies had used a single herbal medicine (23.08%). The external application with oriental medicine for the atopic dermatitis used with Phellodendri Cortex (7), Sophorae Radix (6), Scutellariae Radix (6), Lonicerae Flos (5), Coptidis Rhizoma (5) and so on. Among the clinical studies, the 5 studies were double-blind and randomized-controlled study (50%). The numbers of studies that used Hanifin and Rajka Diagnostic Criteria (1980) were 6 (60%), and that used the Diagnostic Criteria in Korean Atopic Dermatitis (2005) were 4 (40%). Among the clinical studies, categories to evaluate of atopic dermatitis are respectively SCORAD Index (80%), Total IgE (80%), Eosinophil count (70%) and so on. All of the clinical studies (100%) showed a statistically significant decline in atopic dermatitis according to the SCORAD Index, Modified SCORAD Index, the Clinic index score. Among the experimental studies, the numbers of studies that used NC/Nga mice were 9 (56.25%), and out of that 5 studies used BALB/c mice (31.25%). Most of the studies (68.75%) used DNCB as allergy inducing materials. The scales for evaluation of atopic dermatitis were Clinical skin severity score, Histopathologic examination, Immunohematologic examination, safety test and so on. In 12 cases (75%) of experimental studies, the IgE level of experimental group showed a statistically significant decline after using external application. In 8 study cases (50%), Clinical skin severity score of experimental group showed a statistically significant decline after using external application.

Saccharomyces Cerevisiae 효모 추출물 SCP-20의 스트레스 반응, 불안 및 우울에 대한 효과 : 이중 맹검 위약 통제 연구 (The Effects of Saccharomyces Cerevisiae Yeast Extract SCP-20 on Stress Response, Anxiety and Depression : A Double-Blind Placebo-Controlled Trial)

  • 이하민;정영은;채정호
    • 대한불안의학회지
    • /
    • 제5권1호
    • /
    • pp.8-13
    • /
    • 2009
  • Saccharomyces cerevisiae 효모추출물인 SCP-20은 동물실험에서 항스트레스, 항불안 및 항우울 효과를 보인 바 있다. 본 연구는 정상인을 대상으로 위약통제 이중맹검 연구를 시행하여 SCP-20의 효과를 검증하였다. 선별과정을 거치고 충분한 순응도를 보인 61명의 자원자의 정보가 최종 분석에 사용되었다. 이들은 4주간 SCP-20이 70% 함유된 캡슐, SCP-20 99.5% 함유 캡슐 그리고 위약캡슐 중 한가지를 하루 4회 복용하였다. 4주 뒤 SCP-20 복용군은 위약군에 비해 SRI, BAI 점수에서 유의한 개선을 보였으나,BDI 점수변화는 군간 유의미한 차이가 없었고 집단별 사후검정에서 SCP99.5군만이 복용 전후 유의미한 BDI 점수감소를 보였다. HRV는 유의미한 변화를 보이지 않았다. 부작용은 관찰되지 않았다. SCP-20은 정상인에게 투여하였을 때 위약에 비해 유의하게 항스트레스, 항불안 효과를 보이나 항우울 효과는 명확하지 않았으며, 부작용은 보이지 않았다. 향후 SCP-20의 항우울기능 추가 검증 및 환자군을 대상으로 한 대규모, 장기적 연구가 필요하다.

  • PDF

퇴행성 관절염 환자를 대상으로 새로운 진통제 평가를 위한 임상시험자료의 GEE 분석 (Analysis of Repeated Measured VAS in a Clinical Trial for Evaluating a New NSAID with GEE Method)

  • 임회정;김윤이;정영복;성상철;안진환;노권재;김정만;박병주
    • Journal of Preventive Medicine and Public Health
    • /
    • 제37권4호
    • /
    • pp.381-389
    • /
    • 2004
  • Objective : To compare the efficacy between SKI306X and Diclofenac by using generalized estimating equations (GEE) methodology in the analysis of correlated bivariate binary outcome data in Osteoarthritis (OA) diseases. Methods : A randomized, double-blind, active comparator-controlled, non-inferiority clinical trial was conducted at 5 institutions in Korea with the random assignment of 248 patients aged 35 to 75 years old with OA of the knee and clinical evidence of OA. Patients were enrolled in this study if they had at least moderate pain in the affected knee joint and a score larger than 35mm as assessed by VAS (Visual Analog Scale). The main exposure variable was treatment (SKI 306X vs. Diclofenac) and other covariates were age, sex, BMI, baseline VAS, center, operation history (Yes/No), NSAIDS (Y/N), acupuncture (Y/N), herbal medicine (Y/N), past history of musculoskeletal disease (Y/N), and previous therapy related with OA (Y/N). The main study outcome was the change of VAS pain scores from baseline to the 2nd and 4th weeks after treatment. Pain scores were obtained as baseline, 2nd and 4th weeks after treatment. We applied GEE approach with empirical covariance matrix and independent(or exchangeable) working correlation matrix to evaluate the relation of several risk factors to the change of VAS pain scores with correlated binary bivariate outcomes. Results : While baseline VAS, age, and acupuncture variables had protective effects for reducing the OA pain, its treatment (Joins/Diclofenac) was not statistically significant through GEE methodology (ITT:aOR=1.37, 95% CI=(0.8200, 2.26), PP:aOR=1.47, 95% CI=(0.73, 2.95)). The goodness-of-fit statistic for GEE (6.55, p=0.68) was computed to assess the adequacy of the fitted final model. Conclusions : Both ANCOVA and GEE methods yielded non statistical significance in the evaluation of non-inferiority of the efficacy between SKI306X and Diclofenac. While VAS outcome for each visit was applied in GEE, only VAS outcome for the fourth visit was applied in ANCOVA. So the GEE methodology is more accurate for the analysis of correlated outcomes.

인진오령산의 알콜성 간염에 미치는 영향 (Effects of Injinoryung-San on Alcoholic Hepatitis)

  • 홍수현;권오순;김상현;김효진;김기탁;박상은;김원일;강창완;조정효;손창규;윤우상;김경남;홍상훈
    • 동의생리병리학회지
    • /
    • 제22권1호
    • /
    • pp.204-208
    • /
    • 2008
  • This study was performed to investigate the effect of the extracts from Injinoryng-San on liver injury patients induced by alcohol. Injinoryung-San was recorded the drug for jaundice at Hwang-Je-Nae-Kyung. Twenty-seven patients who have intaked alcohol above 40 g, every day, 5 years, twenty-seventy ages were selected. After take a written consent, we divide them into experimental groups and control groups by double blind test. Each groups was evaluated every 2 weeks(2,4,6 weeks). After 2 weeks, Injinoryung-San groups significantly decreased GGT in comparison with control groups(p<0.05). After 4 weeks, Injinoryung-San groups significantly decreased MCV, GGT in comparison with control groups(p<0,05). After 6 weeks, Injinoryung-San groups significantly decreased MCV in comparison with control groups(p<0.05). Reviewing these experimental results, it appears that extracts of Injinoryung-San have pharmaceutical efficacy in GGT, MCV on liver injury patients induced by alcohol. But it has not efficacy in AST, ALT. According to drinking alcohol has becomes social problems, we should effort to make efficacious oriental medicines on alcoholic hepatitis.

서양산 고추냉이 추출물이 함유된 세치제의 효능에 대한 임상적 실험연구 (A CONTROL OF PLAQUE, GINGIVITIS AND ANTI-CARIES EFFECT OF DENTIFRICE CONTAINING HORSERADISH EXTRACTS)

  • 서현우;박호원;김종수;이시영;신일식
    • 대한소아치과학회지
    • /
    • 제39권1호
    • /
    • pp.26-33
    • /
    • 2012
  • 식물성 자연추출물 중 하나인 고추냉이 추출물을 배합한 세치제의 구강환경 개선 효과를 알아보기위해 총72명을 대상으로 교차실험 및 이중맹검법을 실시하여 치면세균막지수, 치은염지수 및 우식활성도검사 등을 비교 검토한 결과 다음과 같은 결론을 얻었다. 1. 치면세균막지수는 초기값에 비해 대조군은 28%, 고추냉이 추출물 배합세치군은 58%의 억제효과를 나타내었다. 2. 치은염지수는 초기값에 비해 대조군은 26%, 고추냉이 추출물 배합세치군은 40%의 억제효과를 나타내었다. 3. Dentocult-SM을 이용한 우식활성도 평가에서는 초기값에 비해 대조군은 4%, 고추냉이 추출물 배합세치군은 69%의 억제효과를 나타내어 고추냉이 추출물 배합세치군이 대조군에 비해 유의할만한 Streptococcus mutans 억제효과를 나타내었다. 이상의 결과들로 보아 고추냉이 추출물을 배합한 세치제는 치면세균막 억제와 치은염의 감소 그리고 우식활성도 억제에 중요한 역할을 하여 구강환경 개선에 뛰어난 효과를 보이는 것으로 사료된다.

선행적 진통 요법의 효과성에 대한 연구 -발치 전과 후 진통 요법의 효과 비교- (A Study on Efficacy of Preemptive Analgesia - A Comparison on Efficacy of Preoperative and Postoperative Analgesic Administration -)

  • 정영수;김문기;박형식;이의웅;강정완
    • 대한치과마취과학회지
    • /
    • 제3권1호
    • /
    • pp.10-18
    • /
    • 2003
  • Background: Studies on the pain have been dealing with many different ways for last several centuries. Especially, preemptive analgesia is being used as a method to control the postoperative pain. Many studies on its efficacy have been processed in different ways about various drugs, administration methods and times for various operations. And the value of preemptive analgesia are still controversial regarding the results of other clinical studies. The authors performed a clinical study on efficacy of preemptive analgesia using an non-steroidal anti-inflammatory drug (NSAID) for the surgical extraction of impacted third molar teeth and present the more effective pain treatment after oral surgery with literature review. Methods: Using a randomized double blind test design, this study compared the analgesic efficacies of an NSAID, Talniflumate 370 mg. This drug administrated first either 1 hour preoperatively (experimental group) or when the pain developed moderately to severely over 5 scale of verbal rating scales (0-10) to respective 30 patients undergoing the removal of impacted third molars. Pain intensity and the time from the end of surgery were assessed postoperatively whenever the patients demanded additional drug over 5 scale for forty eight hours using same verbal rating scales. Results: The sex distribution, the age of the patients. and the time required for surgery in two groups were similar. The average first time for demanding additional drug after surgery was 163.9 minutes in experimental group and 191.5 minutes in control group. At this time, the average pain intensity was 5.8 in experimental group and 6.1 in control group. And the average second time for demanding additional drug was 365.5 minutes in experimental group and 351.8 minutes in control group. At this time. the average pain intensities were 6.6 in experimental group and 6.2 in control group. No statistically significant difference was found between the average first times and second times, and the average pain intensities at first and second times in two groups. Conclusions: From these results the efficacy of preemptive analgesia used in this study was not appeared. This clinical study indicates that many NSAIDs administrated preoperatively in present practices have weak efficacy of preemptive analgesia for postoperative pain, thus the authors recommend that only postoperative analgesics are adequate without preoperative use of analgesics.

  • PDF

화병 환자의 심박변이도 차이에 따른 황련해독탕의 효과: 화병에 대한 무작위 대조 비교임상시험 결과의 추가 분석 (Role of the Baseline Heart Rate Variability to the Effect of the Huanglian-Jie-Du Granule in Hwa-Byung Patients: Supplementary Analysis from the Randomized Trial Comparing Huanglian-Jie-Du Granule and Placebo for Hwa-Byung)

  • 최유진;조성훈
    • 스트레스연구
    • /
    • 제26권4호
    • /
    • pp.305-311
    • /
    • 2018
  • 화병은 뚜렷한 스트레스 사건과 관련되어 가슴의 답답함, 열감, 치밀어 오름, 억울하고 분한 감정 등이 나타나는 증후군이다. 본 논문에서는 화병에 대한 황련해독탕의 임상시험 결과를 교감신경의 활성도를 반영한다고 알려져 있는 심박변이도의 저주파(0.04~0.15 Hz) 영역 값을 중심으로 분석하여 다음과 같은 결과를 얻었다. 첫째, 황련해독탕 시험군에서 초기 심박변이도 저주파 값이 클수록 불면 증상의 개선 정도가 작게 나타났다. 둘째, 위약과 비교했을 때, 황련해독탕은 복용 7일 후 심박변이도 저주파 값을 유의하게 감소시켰다. 셋째, 화병 증상 중 가슴이 답답함, 치밀어 오름, 분노가 심박변이도 저주파 값과 유의미한 상관성이 있었다. 이를 바탕으로 심박변이도는 화병 환자를 평가할 때 유용할 것이라고 기대된다.

Ginsenoside Rg1 supplementation clears senescence-associated β-galactosidase in exercising human skeletal muscle

  • Wu, Jinfu;Saovieng, Suchada;Cheng, I-Shiung;Liu, Tiemin;Hong, Shangyu;Lin, Chang-Yu;Su, I-Chen;Huang, Chih-Yang;Kuo, Chia-Hua
    • Journal of Ginseng Research
    • /
    • 제43권4호
    • /
    • pp.580-588
    • /
    • 2019
  • Background: Ginsenoside Rg1 has been shown to clear senescence-associated beta-galactosidase (SA-${\beta}$-gal) in cultured cells. It remains unknown whether Rg1 can influence SA-${\beta}$-gal in exercising human skeletal muscle. Methods: To examine SA-${\beta}$-gal change, 12 young men (age $21{\pm}0.2years$) were enrolled in a randomized double-blind placebo controlled crossover study, under two occasions: placebo (PLA) and Rg1 (5 mg) supplementations 1 h prior to a high-intensity cycling (70% $VO_{2max}$). Muscle samples were collected by multiple biopsies before and after cycling exercise (0 h and 3 h). To avoid potential effect of muscle biopsy on performance assessment, cycling time to exhaustion test (80% $VO_{2max}$) was conducted on another 12 participants (age $23{\pm}0.5years$) with the same experimental design. Results: No changes of SA-${\beta}$-gal were observed after cycling in the PLA trial. On the contrary, nine of the 12 participants showed complete elimination of SA-${\beta}$-gal in exercised muscle after cycling in the Rg1 trial (p < 0.05). Increases in apoptotic DNA fragmentation (PLA: +87% vs. Rg1: +133%, p < 0.05) and $CD68^+$ (PLA:+78% vs. Rg1:+121%, p = 0.17) occurred immediately after cycling in both trials. During the 3-h recovery, reverses in apoptotic nuclei content (PLA:+5% vs. Rg1 -32%, p < 0.01) and increases in inducible nitrate oxide synthase and interleukin 6 mRNA levels of exercised muscle were observed only in the Rg1 trial (p < 0.01). Conclusion: Rg1 supplementation effectively eliminates senescent cells in exercising human skeletal muscle and improves high-intensity endurance performance.