• 제목/요약/키워드: double blind

검색결과 549건 처리시간 0.026초

슈퍼홍미 미강 추출물의 폐경 후 여성의 혈중 지질 농도 및 대사성 질환 개선 효과 (Superhongmi bran extract improves lipid profile and menopause symptoms: a randomized, placebo-controlled clinical trial)

  • 정수임;남수진;;;강미영
    • 한국식품과학회지
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    • 제51권2호
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    • pp.182-187
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    • 2019
  • 본 연구는 슈퍼홍미 미강 추출물이 폐경 후 갱년기 증상에 및 대사 개선 효과를 확인하고자 수행되었다. 무월경이 지속된 지 5년 미만의 여성을 대상으로 12주동안 진행되었으며 위약대조군 15명, 실험군 15명으로 배정하였고, 1일 2개의 캡슐을 섭취하도록 하였다(슈퍼홍미 미강추출물 700 mg/day). 시험 종료 후 슈퍼홍미 미강 추출물 섭취군의 체중과 BMI 그리고 중성지질과 및 총콜레스테롤은 수준이 유의하게 감소하였다. 혈중 HDL 콜레스테롤과 ApoA1 농도는 약 10% 증가하여 지질대사 개선에 효과를 기대할 수 있었다. 항당뇨과 관련된 지표 중 혈중 glucose와 인슐린이 유의하게 감소하여 인슐린 저항성 지표인 HOMA-IR이 감소한 것을 확인할 수 있었고, 아디포넥틴 수준이 유의하게 증가하였으며, $TNF-{\alpha}$는 슈퍼홍미 미강 추출물 섭취군에서 투여 전보다 유의하게 감소하여 폐경 이후 당질대사 개선에 도움을 줄 수 있을 것으로 보인다. 항산화활성 분석 결과 SOD1, GSH 그리고 TBARS 수준이 실험군에서 감소하였으며, AOPP 는 유의적인 차이를 보이지 않았다. 여성호르몬 중 $17{\beta}-estradiol$과 progesterone 농도는 위약대조군에서 유의하게 감소하였으나 실험군은 섭취기간동안 호로몬 농도를 유지한 것으로 나타나 대조군에 비해 높은 수준을 나타났다. 폐경을 겪은 여성들은 여성호르몬 저하로 인해 갱년기 증상 및 대사증후군 발병 가능성이 증가하는데 슈퍼홍미 미강과 같은 기능성 식품 섭취로 대사증후군 위험인자들에 대한 호전이 높을 것이라 보고 이러한 연구 결과는 갱년기 여성 건강에 시사하는 바가 크다고 생각된다.

일차성 만성불면증 환자에서 경두개 직류전기자극법 치료 효과: 개념 증명 연구 (Effects of Transcranial Direct-Current Stimulation Therapy on Primary Chronic Insomnia: A Proof-of Concept Clinical Trial)

  • 전진선;김태준;구선아;박지숙;김근태;양태원;임정아;변정익;선우준상;정기영
    • Journal of Sleep Medicine
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    • 제15권2호
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    • pp.37-42
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    • 2018
  • Objectives: To assess the effect and safety of transcranial direct-current stimulation (tDCS) in primary chronic insomnia. Methods: A one-month, double-blind, randomized, sham-controlled trial was performed. A total of 7 patients with primary chronic insomnia received tDCS using anodal (n=3), cathodal (n=2), or sham stimulation (n=2). They were followed up at 1 week and 1 month after treatment. The primary outcome measures included improvement in total sleep time (TST), sleep latency (SL), and sleep efficiency (SE) at 1 month follow-up. Results: TST and SE were improved with tDCS at 1 month follow-up in all patients (100%) of the anodal group, one (50%) of the cathodal group, and one (50%) of the sham group. tDCS improved SL at 1 month follow-up in two patients (67%) of the anodal group, one (50%) of the cathodal group, and none (0%) of the sham group. With respect to adverse events, transient itching sensation occurred in one patient of the anodal group. None of the other groups reported adverse events. Conclusions: Our results suggest that tDCS may be effective and safe for treatment of primary chronic insomnia. A larger controlled study needs to be further investigated.

숙잠 함유 복합물의 알코올 대사 및 숙취개선 효능평가 (Evaluation of the effects of Hangover-releasing agent containing freeze-dried mature silkworm larval powder (SMSP) on alcohol metabolism and hangover improvement)

  • 우미선;차지현;김용환;강희택;김현덕;조경원;박성선;이종훈
    • 한국식품과학회지
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    • 제53권1호
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    • pp.72-77
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    • 2021
  • 숙취를 해결하기 위해서는 숙취를 직접적으로 유발하는 물질인 아세트알데하이드의 조절이 가장 중요한 인자로 작용한다. 숙잠을 함유하는 복합물인 시험식품(CKDHC)의 섭취로 혈중 아세트알데하이드 농도가 대조식품 대비 통계적으로 유의하게 감소하여 숙취개선 효능을 확인하였다. 특히, 30분부터 각 시간별(mg/L), 혈중 아세트알데하이드 농도-시간곡선하 면적(AUC), 최고 혈중 아세트알데하이드 농도(Cmax)의 감소를 통해 30분부터 빠른 숙취개선 효능을 확인하였다. 본 연구의 주원료로 사용된 숙잠은 Ji 등(2016a)에 따르면 18종의 아미노산 및 무기질을 모두 함유하며, 고단백 식용곤충으로 간에 좋은 주요 아미노산인 Alanine, Arginine 등을 많이 함유하여 간의 효소활성에 긍정적인 영향을 줄 수 있음을 알수있다. 본 연구결과를 통해 숙잠을 함유하는 시험식품이 숙취해소제로 작용할 수 있으며, 특히 음주 전 섭취시 아세트알데하이드를 빠르게 분해하여 30분부터 숙취 개선에 효과가 있음을 입증하였다.

NMED-01과 NMED-02의 간기능 개선에 대한 인체 효능 평가 (A Randomized, Double-blind, Placebo-controlled Study to the efficacy and Safety of NMED-01 and NMED-02 in Mild Alcoholic Liver Subjects)

  • 박상욱;권용범;김기태;신선미;임강현;고흥;송미경;정윤철;김호철;박주연
    • 대한본초학회지
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    • 제28권6호
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    • pp.31-38
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    • 2013
  • Objectives : The purpose of this study was to determine whether NMED-01 or NMED-02 improves laboratory test results in participants with liver function disorder. Methods : This is a randomized, placebo-controlled trial in which participants, treating physicians and data management staff were blinded to treatment group. The study was conducted at Semyung university oriental medicine hospital in Jecheon where participants with high level of serum ${\gamma}$-GTP (60-350 U/L) were enrolled. The intervention consisted of three times daily ingestion of either two capsules of placebo, NMED-01 (NeuMed. co. ltd., Seoul), or NMED-02 (NeuMed. co. ltd., Seoul) for twelve weeks. To evaluate the efficacy and safety of NMED-01 and NMED-02, we primarily evaluated the degree of decrement of serum ${\gamma}$-GPT level among three groups. Secondarily the decrement of serum ALT, AST, and triglyceride level in each group were also evaluated. Adverse effects were monitored during the twelve weeks treatment. Results : The change of ${\gamma}$-GTP level of NMED-01 group was lower than that of placebo group at the end of 12-week administration ($28.1{\pm}38.7U/L$ vs. $9.3{\pm}27.0U/L$, p=0.046). Other variables including AST, ALT, and triglyceride level were not significantly reduced. The decrement of ${\gamma}$-GPT, AST, ALT, and triglyceride level of NMED-02 group was not significant. There were no significant adverse effects or toxicities during treatment period. Conclusions : Participants receiving NMED-01 had improvement in laboratory test results. Despite a modest sample size, our results suggest that NMED-01 are safe and may be potentially effective in improving liver function. However, NMED-02 have lack of a detectable effect in this study.

옻나무-두충추출혼합물(ILF-RE)의 간기능 개선에 대한 유효성 및 안전성을 평가하기 위한 무작위배정 이중눈가림 인체적용시험 (Randomized Double-blind Human Trial to Evaluate Efficacy and Safety of Rhus verniciflua Stokes (Lacca Sinica Exsiccata) and Eucommia ulmoides Oliver (Eucommiae Cortex) Extract Combination (ILF-RE) on Improvement of Liver Function)

  • 윤영;백향임;진희연;정다영;신뢰;주종천;박수정
    • 대한본초학회지
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    • 제35권1호
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    • pp.45-55
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    • 2020
  • Objectives : The purpose of this study is to determine whether Rhus verniciflua Stokes with Latin name Lacca Sinica Exsiccata, and Eucommia ulmoides Oliver with Latin name Eucommiae Cortex Extract Combination (ILF-RE) improves laboratory test results in participants with liver function disorder. Methods : This study was conducted at Woosuk university Korean medicine hospital where participants with high serum alanine transaminase (ALT) levels from 45 to 135 U/L were enrolled. Subjects received ILF-RE 3.6 g (1.2 g/day as ILF-RE) or placebo 3.6 g for 12 weeks. It was confirmed that urushiol was not detected in ILF-RE. The primary outcomes were the decrement degree of serum ALT and gamma-glutamyl transferase (GGT) levels between two groups. The secondary outcomes were the decrement degree of serum aspartate transaminase (AST), alkaline phosphatase (ALP), lactate dehydrogenase (LD), total bilirubin, total cholesterol, triglyceride (TG) and fatty liver index (FLI) levels between two groups. Adverse events, skin prick tests, laboratory tests, and vital signs were observed and analyzed to confirm the safety of ILF-RE.1) Results : In the ILF-RE group, the liver function index ALT, GGT, lipid metabolism index TG, and fatty liver index FLI were significantly decreased compared to the placebo group. There was no significant difference in ILF-RE group in terms of adverse events, severe adverse events, skin prick test, laboratory test, and vital signs compared with placebo group. Conclusions : ILF-RE was found to be effective in improving liver function. In addition, no clinically significant adverse events or body changes were observed during this study.

Improved postoperative recovery profile in pediatric oral rehabilitation with low-dose dexmedetomidine as an opioid substitute for general anesthesia: a randomized double-blind clinical trial

  • Naveen, Naik B;Jaiswal, Manoj Kumar;Ganesh, Venkata;Singh, Ajay;Meena, Shyam Charan;Amburu, Vamsidhar;Soni, Shiv Lal
    • Journal of Dental Anesthesia and Pain Medicine
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    • 제22권5호
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    • pp.357-367
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    • 2022
  • Background: Low-dose dexmedetomidine may be a suitable alternative to opioids for pediatric ambulatory procedures under general anesthesia (GA). However, the recovery profile remains unclear. Herein, we aimed to evaluate the effects of low-dose dexmedetomidine on the recovery profile of children. Methods: Seventy-two children undergoing ambulatory oral rehabilitation under GA were randomly and equally distributed into two groups (D and F). Group D received an infusion of dexmedetomidine 0.25 ㎍/kg for 4 min for induction, followed by maintenance of 0.4 ㎍/kg/h. Group F received an infusion of fentanyl 1 ㎍/kg over 4 min for induction, followed by maintenance at 1 ㎍/kg/h. The primary outcome was the extubation time. The secondary outcomes were awakening time, end-tidal sevoflurane (ET-Sevo) requirement, change in hemodynamic parameters, Richmond Agitation-Sedation Scale (RASS), Children's Hospital of Eastern Ontario pain scale (CHEOPS) score, length of PACU stay, and incidence of adverse events. Results: Statistically significant differences were observed in the recovery profile between the groups: the median time for extubation was 3.65 (3.44-6.2) vs. 6.25 (4.21-7) minutes in groups D vs. F (P=0.001), respectively, while the corresponding awakening times were 19 (18.75-21) and 22.5 (22-24) minutes, respectively (P < 0.001). The mean ET-Sevo was low in group D (1.1 vs. 1.2; P < 0.001). The heart rate was significantly low across all time points in group D, without resulting in bradycardia. The median RASS and CHEOPS scores were also significantly lower in group D. No significant differences were observed in the mean arterial pressure, incidence of adverse events, or length of PACU stay. Conclusion: Low-dose dexmedetomidine was more effective than fentanyl as an opioid substitute at providing a better recovery profile in pediatric ambulatory oral rehabilitation under GA. Dexmedetomidine also significantly reduced sevoflurane consumption without causing adverse events or prolonging hospital stay.

$1996{\sim}1998$년 유고슬라비아에서 실시한 한탄바이러스 불활화 백신($Hantavax^{TM}$)의 면역효과에 대한 야외시험 (A Field Efficacy Trial of Inactivated Hantaan Virus Vaccine ($Hantavax^{TM}$) Against Hemorrhagic Fever with Renal Syndrome (HFRS) in the Endemic Areas of Yugoslavia from 1996 to 1998)

  • 주용규;;;;;우영대;안창남;김훈;장양석;박승철;김민자;이은실;이호왕
    • 대한바이러스학회지
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    • 제29권2호
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    • pp.55-64
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    • 1999
  • In Yugoslavia, hemorrhagic fever with renal syndrome (HFRS) is one of the important national health problem, but no vaccine has been used to prevent HFRS. Since first HFRS case in 1952, sporadic cases of HFRS occurred every year and over 4,000 registered cases with $1{\sim}16%$ mortality so far. We performed a prospective, randomized double-blind placebo-controlled trial to evaluate the effectiveness of $Hantavax^{TM}$ against HFRS in 3,900 healthy adults living in the endemic areas of Yugoslavia. 1,900 people were given 0.5 ml of Hantavax subcutaneously twice at one month interval and a booster shot at one year after. For controls other 2,000 healthy people were given 0.5 ml of physiolosical saline as a placebo. We investigated HFRS cases in both the vaccinated and nonvaccinated groups by monitoring the program for patient registration in the areas from 1996 to 1998, and the effect of vaccine was analyzed epidemiologically. No confirmed case of HFRS was observed among 1,900 Hantavax vaccinees, while 20 confirmed cases were observed among 2,000 nonvaccinated control group. There were no remarkable side effects among the vaccinees either locally or in general after inoculation of the vaccine. The Hantavax vaccine showed statistically significant protective efficacy against HFRS among Yugoslavian people.

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천왕보심단(天王補心丹)∘쌀발효추출물(GABAːgamma-aminobutyric acid 30%) 복합물의 항(抗)스트레스에 대한 유효성 연구ː무작위 배정 및 이중맹검 (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)

  • 홍초영;서상권;나승곤;조호성;이미경;진무현;노석선;주영승
    • 대한본초학회지
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    • 제38권2호
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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.

수면이갈이 환자에서 교합안정장치 사용 후 교합력 및 동기능적교합분석: 예비 연구 (Changes of bite force and dynamic functional occlusion analysis after occlusal stabilization splint therapy in sleep bruxism patients: a pilot study)

  • 김재연;최이슬;송율빈;박원서;김성택
    • 구강회복응용과학지
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    • 제38권4호
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    • pp.204-212
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    • 2022
  • 목적: 수면이갈이 환자에서 한달 간 수면 시 교합안정장치를 장착하였을 때 교합력과 교합 접촉 면적 및 동기능적교합분석의 변화량을 비교하고자 하였다. 연구 재료 및 방법: 2021년 10월부터 2022년 7월까지 연세대학교 치과대학병원 구강내과 외래에 방문한 수면이갈이 환자 30명 중 교합안정장치를 수면 중 착용하는 실험군(treatment; n = 15)과 교합안정장치를 착용하지 않는 대조군(control; n = 15)으로 구성하였다. 교합안정장치 장착 전, 장착 1개월 후에 교합력 검사와 동기능적교합분석(측방, 전후방 하악 운동 시 좌/우 힘의 균형, 평균 교합력, 최대 교합력, 최대 접촉 개수)을 진행하였다. 결과: 한달 간 수면 중 교합안정장치를 착용하는 실험군과 교합안정장치를 착용하지 않는 대조군에서 교합력과 교합 접촉 면적은 차이가 없었으나 측방 및 전후방 운동에서 평균 교합력과 최대 교합력, 전후방 운동에서 최대 접촉 개수가 유의한 차이가 있었음을 관찰하였다. 결론: 교합안정장치가 측방, 전후방 운동을 하는 이갈이 환자에게 도움이 될 것으로 사료되며, 향후 추가적으로 대단위 집단을 대상으로 하는 이중 맹검연구가 필요할 것으로 사료된다.

Effects of GV1001 on Language Dysfunction in Patients With Moderate-to-Severe Alzheimer's Disease: Post Hoc Analysis of Severe Impairment Battery Subscales

  • Hyuk Sung Kwon;Seong-Ho Koh;Seong Hye Choi;Jee Hyang Jeong;Hae Ri Na;Chan Nyoung Lee;YoungSoon Yang;Ae Young Lee;Jae-Hong Lee;Kyung Won Park;Hyun Jeong Han;Byeong C. Kim;Jinse Park;Jee-Young Lee;Kyu-Yong Lee;Sangjae Kim
    • 대한치매학회지
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    • 제22권3호
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    • pp.100-108
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    • 2023
  • Background and Purpose: The efficacy and safety of GV1001 have been demonstrated in patients with moderate-to-severe Alzheimer's disease (AD). In this study, we aimed to further demonstrate the effectiveness of GV1001 using subscales of the Severe Impairment Battery (SIB), which is a validated measure to assess cognitive function in patients with moderate-to-severe AD. Methods: We performed a post hoc analysis of data from a 6 month, multicenter, phase 2, randomized, double-blind, placebo-controlled trial with GV1001 (ClinicalTrials.gov, NCT03184467). Patients were randomized to receive either GV1001 or a placebo for 24 weeks. In the current study, nine subscales of SIB-social interaction, memory, orientation, language, attention, praxis, visuospatial ability, construction, and orientation to name-were compared between the treatment (GV1001 1.12 mg) and placebo groups at weeks 12 and 24. The safety endpoints for these patients were also determined based on adverse events. Results: In addition to the considerable beneficial effect of GV1001 on the SIB total score, GV1001 1.12 mg showed the most significant effect on language function at 24 weeks compared to placebo in both the full analysis set (FAS) and per-protocol set (PPS) (p=0.017 and p=0.011, respectively). The rate of adverse events did not differ significantly between the 2 groups. Conclusions: Patients with moderate-to-severe AD receiving GV1001 had greater language benefits than those receiving placebo, as measured using the SIB language subscale.