• 제목/요약/키워드: Clinical trial,

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양측 눈가림, 무작위배정, 다기관공동 제 3 상 임상시험 결과 : 퇴행성 관절염에 대한 조인스(SKI 306X)정과 Diclofenac과의 비열등성 임상시험 (A randomized, double-dummy, multicenter non-inferiority clinical trials to evaluate the efficacy and the safety of Joins(SKI 306X) compared to diclofenac in patients with osteoarthritis of the knee)

  • 정귀옥;정영복;성상철;안진환;노권재;김정만;박병주
    • 대한예방의학회:학술대회논문집
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    • 대한예방의학회 2001년도 제53차 추계 학술대회 연제집
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    • pp.302-304
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    • 2001
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혈관성 치매 치료 한약물 임상연구 고찰 (Review of Clinical Trials about Herbal Medicine for Vascular Dementia)

  • 김가나;조성훈
    • 동의신경정신과학회지
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    • 제23권4호
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    • pp.37-48
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    • 2012
  • Objectives : The purpose of this study is to investigate the frequently used herbal materials among herbal prescription for vascular dementia. Methods : Every article relevant to vascular dementia was initially obtained from a Korean database and PubMed. Keywords searched were 'vascular dementia', 'herbal medicine' and 'human'. Results : Clinical study, which vascular dementia were treated with herbal medicine, were 12. Among these 12 articles, 6 were case study, 1 was Controlled Clinical Trial and 5 were Ramdomized Controlled Trial (RCT). High frequently used herbal materials were Ginseng Radix (9 times), Cnidii Rhizoma (8 times), Glycyrrhizae Radix, Citri Pericarpium, Astragali Radix and Angelicae Gigantis Radix (6 times). Conclusions : We could know frequent-used herbal medicine for vascular dementia. To be aware of the frequently used herbal medicine for vascular dementia can be helpful in adding herbal materials to prescription in a clinical treatment and development of new drugs.

Association between Smoking and Mortality: Khon Kaen Cohort Study, Thailand

  • Kamsa-ard, Siriporn;Promthet, Supannee;Lewington, Sarah;Burrett, Julie Ann;Sherliker, Paul;Kamsa-ard, Supot;Wiangnon, Surapon;Parkin, Donald Maxwell
    • Asian Pacific Journal of Cancer Prevention
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    • 제14권4호
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    • pp.2643-2647
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    • 2013
  • Background: Despite anti-smoking campaigns, smoking prevalence among Thai males aged 30 or older is high, at around 50%. The purpose of this study was to determine the relationship between smoking and mortality in a rural Thai community. Materials and Methods: Subjects enrolled into the Khon Kaen cohort study between 1990 and 2001 were followed up for their vital status until $16^{th}$ March 2012. The death resource was from the Bureau of Policy and Strategy, Ministry of Interior, Thailand. A Cox proportional hazards model was used to analyse the association between smoking and death, controlling for age, education level and alcohol drinking, and confidence intervals were calculated using the floating risk method. Results: The study recruited 5,962 male subjects, of whom 1,396 died during a median 13.5 years of follow-up. Current smokers were more likely to die than never smokers after controlling for age, education level and alcohol drinking (HR, 95%CI: 1.41, 1.32-1.51), and the excess mortality was greatest for lung cancer (HR, 95%CI: 3.51, 2.65-4.66). However, there was no increased risk with increasing dose of tobacco, and no difference in risk between smokers of yamuan (hand-rolled cigarettes) and manufactured tobacco. Conclusion: Mortality from cancer, particularly lung cancer, and from all causes combined is dependent on smoking status among men in rural Thailand, but the relative risks are lower than have been reported from studies in high income countries, where the tobacco epidemic is more established.

안면홍조에 대한 임상시험 참가자의 증상 발현 양상에 관한 연구 (A Cross Section Study : Hot Flush of Postmenopausal Women Who Participated in a Clinical Trial)

  • 노진주;정수경;성준호;이승덕;안홍엽;오달석;최선미;김동일
    • 대한한방부인과학회지
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    • 제19권4호
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    • pp.205-215
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    • 2006
  • Purpose : To identify factors related to the severity and frequency of hot flush of postmenopausal women who participated in a clinical trial. Methods : A cross-section study of 34 postmenopausal women between 40 and 60 years of age was done. VAS(visual analog scale) was used to evaluate the hot flush degree. Statistical analysis was performed with multiple linear regression analysis. Results : Hot flush VAS was proportional to the percent body fat with 1.467 regression coefficient (p-value= 0.010). It implies that the symptom of hot flush becomes worse as the percent body fat increases. Some hormones also have effects on hot flush. We found that LH might cause increment of hot flush VAS(i.e., the corresponding regression coefficient is 0.912). Sasang constitution was not relevant to the hot flush degree. Hot flush VAS seemed to increase as the vascular aging degree by SA-2000 getting worse, but it was not statistically significant (p-value= 0.594). Conclusion : This study is a part of a prospective clinical trial. For more accurate result, larger-scale cross-section study or clinical trial are necessary.

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적작약 추출물의 대식세포에 대한 염증억제 효과 (Suppression Effect of the Inflammatory Response in Macrophages by Paeoniae Radix Rubra Extracts)

  • 박종필;손정현;김용민;정준희;임강현;이은용;김이화
    • 한국약용작물학회지
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    • 제19권5호
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    • pp.373-379
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    • 2011
  • Paeoniae Radix Rubra is a preparation consisting of desiccated roots of Paeonia lactiflora PALL (belonging to Ranunculaceae). Paeoniae Radix Rubra is used as a medicinal herb in Asian countries to treat many diseases. Ethanol- or water-based extracts of Paeoniae Radix Rubra were prepared and tested on RAW 264.7 cells, a murine macrophage cell line. The expression of some pro-inflammatory proteins, including inducible nitric oxide synthase (iNOS), cyclooxygenase-2 (COX-2), extracellular signal-regulated kinase 1/2 (ERK1/2) and phosphorylated ERK1/2 was detected by Western blot analyses, while PGE2 expression was quantified by ELISA. Both the water and ethanol extracts of Paeoniae Radix Rubra suppressed LPS-induced nitric oxide (NO) production and exhibited cell toxicity in accordance with increased NO production. Also, both extracts reduced the expression of COX-2 and iNOS, and inhibited phosphorylation of ERK1/2 in LPS-stimulated RAW 264.7 cells. Extracts prepared from Paeoniae Radix Rubra contain anti-inflammatory agents that inhibit the iNOS and MAPK pathways.

갈근강황추출물의 갱년기 증상 개선에 대한 유효성 및 안전성 평가 (Efficacy and Safety of Extract Obtained from Pueraria thunbergiana Bentham and Curcuma longa L. on the Improvement of the Menopausal Symptoms)

  • 안하영;허다희;김용재;차민석;이동녕;김형준
    • 대한한방부인과학회지
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    • 제33권4호
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    • pp.75-92
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    • 2020
  • Objectives: This clinical trial is performed to investigate the effect of improving the menopausal symptoms and the safety of extract obtained from Pueraria thunbergiana Bentham and Curcuma longa L. in menopausal women Methods: This study was randomized, double blinded, placebo-controlled clinical trial. 110 women with menopausal symptoms were assigned to treatment group (n=55) and control group (n=55). The results of this study were evaluated through changes in Kupperman Index score, Menopause-specific Quality of Life Questionnaire (MENQOL) score, degree of hot flashes and sweating, Body Mass Index(BMI), laboratory test results including female hormones. Results: In the treatment group compared to before baseline, there was significant difference in the Kupperman Index total score, score of each item in the Kupperman Index, MENQOL total score, hot flush and sweating visual analogue scale (VAS), hot flush score, and hot flush duration at one time. However, there was also a significant change compared to baseline in the control group, there was no significant difference between the treatment group and the control group. There was no significant change in female hormone levels in both group, and there were no adverse events associated with the clinical trial product. Conclusions: This clinical trial showed that extract obtained from Pueraria thunbergiana Bentham and Curcuma longa L. was helpful in improving menopausal symptoms in menopausal women without significant side effects.

만성피로증후군에 대한 소요산(逍遙散)과 그 변방(變方)의 효과 : 메타분석을 통한 체계적인 문헌고찰 (Effectiveness of Soyo-san (Xiaoyao-san) and its Modifications on Chronic Fatigue Syndrome: a Systematic Review and Meta-analysis)

  • 김준열;송정윤;남동현
    • 동의생리병리학회지
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    • 제34권3호
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    • pp.117-125
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    • 2020
  • The purpose of this review is to confirm whether Soyo-san (Xiaoyao-san) and its modifications is effective on alleviating clinical symptoms in chronic fatigue syndrome (CFS) patients. We collected clinical trials (randomized controlled trial, quasi-randomized controlled trial, controlled clinical trial) to investigate the effects of Soyo-san and its modifications on general symptoms, fatigue, depression and anxiety in CFS patients. The databases used for data retrieval were Pubmed, Central Cochrane, Embase, CNKI, CQVIP, Wanfang, CiNii, OASIS, RISS, and Koreamed. We performed selection/exclusion process from the found studies to conform with prespecified criteria, and assessed the final included trials according to the Cochrane risk of bias tool. The included studies were classified based on the interventions in experimental and control group. Eight randomized controlled trials and one controlled clinical trial (total 921 participants) were eligible and their results were synthesized in the meta analysis. The synthesis showed a considerable effect of Soyo-san and its modifications on improvement of general symptoms (relative risk 0.27 [95% CI 0.19 to 0.39], Z=7.03, P<0.00001; I2=0%) and fatigue severity (SMD -1.20 [95% CI -1.46 to -0.93], Z=8.78, P<0.00001; I2=52%) in CFS patients, while Effect on depression and anxiety were inconclusive. We found that Soyo-san and its modifications were effective for improvement of general symptoms and fatigue severity in CFS post-treatment.

한방 과립제의 폐경 후 삶의 질 개선 효과에 관한 연구 - 당귀작약산 및 계지복령환 과립제의 폐경후 삶의 질 개선에 대한 임상연구 (A Clinical Trial to Verity the Quality of Life Improvement Efficacy of Dangguijakyak-san and Gyejibongnyeong-hwan Granulation in Postmenopausal Women.)

  • 박제민;양정민;김동일
    • 대한한방부인과학회지
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    • 제20권3호
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    • pp.213-228
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    • 2007
  • Purpose: This master‘s thesis to evaluate the grade of life after medication a Dangguijakyak-san(pasabu) and Gyejibongnyeong-hwan(cheongwal) with in postmenopausal women get lowering quality of life caused by vasomotor symptoms with hot flush. Methods: A subject who signing on the clinical trial written consent by self-will is registered this clinical trial after decided suitable by selection and exception standard, after take a medical experiment and checkup according to clinical trial plan. Registered subject should valuated by settled schedule after take the testing medicine 1,2 during thirty-day. In this period, a subject allocated at relatively better suited experimental group by oriental doctor after consideration of general efficacy and nature of a medicine at second visiting. Results: The result of comparison in the remedial value with sixteen patients who ended the experiment is like next list. 1. There's no regarded difference of comparison in general conditions between two patient groups. 2. There's no regarded difference during observation period before take medicine. 3. By period of measurement, there's something regarded differences most of patients of two parts after taking medicine. 4. There's no regarded difference at alteration phase of each standard according to kind of medicine. 5. There's no abnormal views reflected at allergy, Laboratory and Physical Examination during experiment. Conclusion: This experiment evidence a Dangguijakyak-san and Gyejibongnyeong-hwan can help for improvement generally life quality of postmenopausal women and certify safety of herbs.

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알레르기 비염 질환자를 대상으로 한 더덕(Codonopsis lanceolata (S. et Z.) Trautv.) 추출물의 과민면역반응 개선에 대한 유효성 및 안전성 평가 (Efficacy and Safety of Codonopsis lanceolata (S. et Z.) Trautv. Extract on the Improvement of the Hypersensitivity Reaction in Allergic Rhinitis Patients)

  • 안하영;부희옥;김형준
    • 대한본초학회지
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    • 제34권1호
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    • pp.13-21
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    • 2019
  • Objectives : This clinical trial is performed to investigate the effect of improving the hypersensitivity reaction and the safety of powdered ethanol extract Codonopsis lanceolata (S. et Z.) Trautv. for allergic patients. Methods : This study was randomized, double blinded, placebo-controlled clinical trial. 60 allergic rhinitis subjects were randomly assigned to Treatment group(n=30) and Control group(n=30). They were received the test substance or placebo in their $1^{st}$ and $2^{nd}$ visit, and took it once a day, 1 powder bag per 1 time, for 8 weeks. The freeze dried powder of Codonopsis lanceolata (S. et Z.) Trautv. was mixed with 30% ethanol and the filtrate was collected thrice with constant stirring of the mixture. The placebo was prepared in the same form as the test substance by replacing with corn starch. Total Nasal Symptom Score(TNSS) questionnaires and laboratory tests were performed at the screening and last visit to evaluate the efficacy. And to assess safety, vital signs and adverse events were confirmed at every visit. Statistical analysis about the result was performed using SAS 9.4. Results : In treatment group, there was a significant decrease in B cell after taking the test substance(p<0.005). And there was a statistically significant difference between groups(p<0.005). Changes in nasal symptoms were not statistically significant between groups, and both groups showed statistically significant differences before and after the test(p<0.0001). Also there were no adverse events associated with the clinical trial product. Conclusions : This clinical trial showed that Codonopsis lanceolata (S. et Z.) Trautv. extract was helpful in improving the hypersensitivity reaction in allergic patients without significant side effects.

만성피로에 대한 공진단과 쌍화탕의 안전성 및 유효성 평가를 위한 무작위배정, 이중눈가림, 위약대조 임상시험 : 임상연구 프로토콜 (Randomized, Double-blind, and Placebo-controlled a Clinical Study for Chronic Fatigue via the Analysis of Efficacy and Safety of Gongjin-dan and Ssanghwa-tang : Study Protocol)

  • 최준용;임병묵;신현규;김기봉
    • 대한예방한의학회지
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    • 제26권3호
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    • pp.97-108
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    • 2022
  • Objectives : The purpose of this study is to confirm the efficacy and safety of Gongjin-dan and Ssanghwatang for chronic fatigue. Methods : A total of 90 people, between 19 and 65 years old, will be recruited to participate in a randomized, double-blind, and placebo-controlled a clinical trial. Participants in the Gongjin-dan group will take one pill of Gongjin-dan along with three packs of placebo oral liquid Ssanghwa-tang per day for 4 weeks. Participants in the Ssanghwa-tang group will take three packages of liquid Ssanghwa-tang and one placebo Gongjindan pill per day for 4 weeks. In the placebo group, participants will take one pill of placebo Gongjin-dan and three packs of placebo liquid Ssanghwa-tang per day, for 4 weeks. Outcomes will be measured at the baseline, 4th week, and 6th week. The primary outcome is the change in the Fatigue Severity Scale (FSS). Secondary outcomes are the change of Multidimensional Fatigue Inventory-20 (MFI-20), Chalder Fatigue Scale (CFQ), Short-Form 36 Health Survey (SF-36), Korean Version of Schedule of Fatigue and Anergy/General Physician (SOFA/GP), Glucose, Lactate, Ammonia, Free Fatty Acid (FAA), d-ROMs&BAP, Selenium, and Cortisol. Results : This trial was approved by the institutional review board of Pusan National University Korean Medicine Hospital (registry number: PNUKHIRB 2021-10-005). Recruitment opened in November 2021 and is supposed to be completed by December 2022. Conclusions : This trial will provide clinical information to determine the efficacy and safety of Gongjindan and Ssanghwa-tang for chronic fatigue.