• Title/Summary/Keyword: Electronic Clinical Trial

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A Systematic Review of Clinical Studies for Herbal Medicine of Dementia - based on Korean Literature - (치매의 한약물 치료에 대한 체계적 임상논문 고찰 - 국내문헌을 중심으로 -)

  • Kwon, Yong-Ju;Cho, Hye-Young;Whang, Wei-Wan;Cho, Seung-Run
    • Journal of Oriental Neuropsychiatry
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    • v.21 no.4
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    • pp.151-161
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    • 2010
  • Objectives : This study aimed to evaluate any clinical studies regarding the herbal medicine for dementia focusing on Korean literature for future rigorous clinical research. Methods: Every article relevant to dementia was initially obtained from oriental medical related journals by electronic search at journal web sites or manual searches. Journals were limited to those registered with the Korea Research Foundation. From initial findings. two independent reviewers selected clinical articles and these articles were further analyzed separately by predefined criteria according to prospective and retrospective studies. For randomized controlled trial and non randomized controlled trial. quality assessment was also conducted. Results: From ninety seven patients initially obtained articles. twenty three patients were finally analyzed. One article was randomized controlled study. Four articles were prospective whereas eighteen patients were retrospective. In the qualitative evaluation of prospective articles. there was deduction regarding pre-calculated study size and prospective data collecting. Assessment measurement most frequently used was Mini Mental State Examination. The order of frequency of use herbs were identified. Conclusions : According to our study. the herbal medicine for dementia in general showed a positive effect in the cognitive aspects of dementia patients. Further well-designed randomized controlled studies should be conducted.

Status Report on Usage of Electronic Case Report Form for Clinical Study (임상연구 전자증례기록지의 사용 현황 조사)

  • Baek, Young-Hwa;Kim, Ho-Seok;Lee, Si-Woo;Jin, Hee-Jeong
    • The Journal of the Korea Contents Association
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    • v.12 no.12
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    • pp.714-720
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    • 2012
  • With the help of information technology, it is the most important to collect clinical data correctly in clinical trials. For this, recently, in many pharmaceutical companies and Clinical Research Organizations (CRO) have tried to adopt an Electronic Case Report Form (eCRF) system. The eCRF system is a computerized system designed for collecting and managing clinical data in clinical trials. Although the eCRF is recognized as a significant system for clinical trials, until now there are no widely useable, due to the huge effort and expense at the initiatory stage of adopting eCRF system. In this study, we inquired the use of eCRF system developed for clinical trial at Korea Institute of Oriental Medicine. Especially, we focused on the time required for entering clinical data into the eCRF, hours of use, and the number of queries according to the time flow.

A Comparative Clinical Study on an Electronic Moxibustion with Acupuncture for Dry Eye Syndrome (건성안 증후군에 대한 전자뜸과 침의 효과 비교 임상연구)

  • Ji-Shik Park;Ji-Hoon Song;Min-Yeong Jung;Jung-Hwa Choi;Soo-Yeon Park
    • The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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    • v.36 no.1
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    • pp.64-77
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    • 2023
  • Objectives : Recently, the number of patients with dry eye syndrome has been steadily increasing. However, established treatment for it does not yet exist. This study compared electronic moxibustion with acupuncture for patients with dry eye in terms of efficacy and safety. Methods : This trial was designed as an investigator-initiated, single-blinded, comparative, randomized controlled trial. Thirty patients with dry eye were randomized to the electronic moxibustion treatment group(EMG) or the acupuncture treatment group(AG) in equal proportion. The participants who assigned to the EMG were treated with electronic moxibustion to ten acupoints including both sides of BL2, GB14, TE23, and LI4 for 12 minutes. The participants who were assigned to the AG were treated with acupuncture to the same acupoints for 15 minutes. Over 4 weeks, each intervention was carried out twelve times in total. The primary outcome was the ocular surface disease index(OSDI). The secondary outcomes were the subjective symptoms visual analog scale(VAS), quality of life(QoL), Schirmer I test(SIT), and general assessment. Adverse events and vital signs were also investigated for safety assessment. Results : In intragroup comparisons, both the EMG and the AG significantly improved the OSDI scores, the subjective symptoms VAS scores, the QoL scores, and the SIT results after 4 weeks of the trial. However, there were no statistical differences in intergroup comparisons between the two groups after 4 weeks. The safety of electronic moxibustion and acupuncture was confirmed by no occurrence of serious adverse events. Conclusions : Both electronic moxibustion and acupuncture were effective for dry eye syndrome, and they were safe. Electronic moxibustion and acupuncture can be used for dry eye syndrome as equivalent treatments.

Chuna Manual Therapy for Primary Insomnia; A Review of Clinical Study (일차성 불면증의 추나 치료에 대한 문헌 연구 보고)

  • Hwang, Man-Suk
    • Journal of Korean Medicine Rehabilitation
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    • v.26 no.3
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    • pp.79-84
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    • 2016
  • Objectives To evaluate the evidence supporting the effectiveness of Chuna manual therapy for primary insomnia. Methods The researcher conducted search across the 3 electronic databases (Pubmed, CAJ and Oasis) to find all of randomized controlled clinical trials(RCTs) that used Chuna manual therapy as a treatment for primary insomnia. Results Four RCTs met inclusion criteria. The meta-analysis showed positive results for the use of Chuna manual therapy in terms of the PSQI when compared to medication treatments alone. Positive results were also obtained, in terms of the PSQI, when comparing Chuna manual therapy combined with acupuncture therapy to acupuncture therapy alone, but was not statistically significant. Conclusions The review found encouraging but limited evidence of Chuna manual therapy for primary insomnia. We recommend clinical trials which compare the effectiveness of Chuna manual therapy with usual care to obtain stronger evidence without the demerits of trial design.

A Review of Domestic Clinical Studies about Clinical and Subclinical Hypothyroidism Treated with Korean Medical Interventions (현성 및 불현성 갑상선 기능 저하증에 관한 국내 한의학 임상 연구 고찰)

  • Lim, Bo-ra;Kim, Chang-Kyu;Park, Jin-seo;Jeon, Gyeong-ryung;Cho, Jun-ho;Kwon, Do-ick
    • The Journal of Internal Korean Medicine
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    • v.39 no.4
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    • pp.645-661
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    • 2018
  • Objectives: The aim of this paper was to aid Korean clinical practices for determining clinical and subclinical hypothyroidism and to identify further relevant studies by summarizing the present domestic clinical studies. Methods: The research consisted of a review of articles up to July, 2018 found by searching 'Hypothyroidism' and 'Hashimoto's thyroiditis' as keywords in five domestic electronic databases. Results: Only nine studies satisfied the selection criteria and were analyzed. These included six case reports, two controlled clinical trials, and one randomized controlled trial. Of these, Anjeonleejoong-tang was the most frequent herbal medicine used to treat hypothyroidism. Conclusions: Systematic and large-scale research studies are needed to standardize the guidelines for traditional Korean treatment of hypothyroidism.

A clinical literature review and research-trends analysis of bee venom pharmacopuncture for cancer patients (암 환자에 대한 봉독 약침요법의 임상문헌 고찰 및 연구동향 분석)

  • Kim, Joo-Hee
    • The Journal of Korean Medicine
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    • v.41 no.3
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    • pp.247-259
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    • 2020
  • Objectives: This review aims to investigate clinical studies related to bee venom pharmacopuncture for cancer patients and to analyze the research trend for further study. Methods: We searched for clinical studies using bee venom pharmacopuncture therapy on patients with cancer through the electronic databases including Pubmed, Cochrane library, OASIS, KISS, NDSL, and KMBASE. There was no restriction on language and publication date, and after selection/exclusion process, the study design, target disease, intervention details including acupoints, treatment frequency and period, outcomes, study results and adverse events were extracted. Results: Thirteen clinical studies were finally selected. There were a randomized controlled trial RCT about the effect of sweet bee venom pharmacopuncture on cancer-related pain, and three case series about chemotherapy-induced peripheral neuropathy. In case reports, there were nine studies about oligodendroglioma, plexiform neurofibroma, breast cancer, prostate cancer, lung cancer, urachal adenocarcinoma, malignant melanoma, and atypical squamous cells of undetermined significance. The bee venom therapy affected the improvement of outcomes such as symptoms, quality of life, tumor response, and lab findings. Conclusions: The present study found that bee venom therapy is applicable to the treatment of cancer patients, and showed some effect on various symptoms. However, due to insufficient number and quality of studies, well designed and high-quality clinical trials are necessary to confirm the effectiveness and safety of bee venom pharmacopuncture therapy in patients with cancer.

Effect and Safety of Oxygen Chamber Therapy on Cold Hypersensitivity: A Randomized, Controlled Trial (냉증에 대한 산소챔버의 임상 효능 및 안전성 연구)

  • Ha, Hun-Yong;Yoon, Dal-Hwan;Go, Ho-Yeon;Han, Yong-Dae;Kim, Nam-Sik;Nam, Eun-Young;Kim, Hyung-Jun
    • The Journal of Korean Obstetrics and Gynecology
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    • v.26 no.4
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    • pp.123-139
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    • 2013
  • Purpose: Cold hypersensitivity is regarded to be associated with blood circulation. This study is aims to evaluate the effects and safety of oxygen chamber therapy on cold hypersensitivity by comparing the temperature and Visual Analogue Scale. Methods: 42 outpatients who visited ${\bigcirc}{\bigcirc}$ University Oriental Hospital from July 11th, 2013 to August 28th, 2013 were analyzed. Patients were subjected to thermometer, and those with thermal difference greater than $0.3^{\circ}C$ between upper arm and palm and also with more than VAS 4 of cold hypersensitivity were diagnosed with cold hypersensitivity. 42 outpatients diagnosed with cold hypersensitivity are divided into two groups, one is the experimental group consisted of 21 patients and other was control group consisted of 21 patients. The experimental group had oxygen chamber therapy 10 times for 4 weeks. Thereafter the effects of oxygen chamber therapy on cold hypersensitivity was analyzed with t-text using SPSS for Windows version 21. Results: After the oxygen chamber therapy, experimental group had considerable improvement on cold hypersensitivity, in consequence of decreasing rate of thermal difference and VAS of cold hypersensitivity. Ear deafness and hand numbness were reported as an adverse effects in experimental group, but there was no serious adverse effects. Conclusions: This clinical trial showed oxygen chamber therapy could be effective and safe to reduce cold hypersensitivity.

A Study on the Ion Transfer System(WIT-I) for Improve on Side effect of Pharmacotherapy (약물치료의 부작용개선을 위한 이온도입 시스템(WIT-I)에 관한 연구)

  • Eo, Y.K.;Yang, K.M.;Chae, J.U.;Lee, I.S.;Lee, J.H.;Jeong, D.M.
    • Proceedings of the KOSOMBE Conference
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    • v.1996 no.05
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    • pp.226-231
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    • 1996
  • Recently Iontophoresis is tried to physical therapy field.. It is method for direct penetrate to skin with ionization pharmacon because it is decreased side effect of pharmacon treatment such as gastrophathy and aphylaris of disease-causing germs. We designed WIT-I that is trial manufacture for clinical experiment This system is has been elrectrical paramete with 0-140V out range, 1-7mA current 1-15mim time set. Invite experiment, WIT-I kept designed performance which is a constant current in variable load resistance such as skin and electrode contact. It is estimated to have a practical use for physical therapy by iontophcresis.

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Bee Venom Therapy on Autoimmune Disease Reviewed in PubMed Database (자가면역질환의 봉독요법에 대한 Pubmed 검색을 통한 고찰)

  • Yi Woong-Kyung;Lee Yun-Ho;Koh Hyung-Kyun
    • Journal of Acupuncture Research
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    • v.18 no.6
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    • pp.232-239
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    • 2001
  • Objective & Method : To identify current state of bee venom therapy(BVT) research as a treatment of autoimmune diseases, we reviewed the PubMed electronic database. 9 articles with clinical implications were discussed. Results : BVT is reported as effective in the treatment of such autoimmune related diseases as rheumatoid arthritis and insulin dependent diabetes mellitus in animal experiment, The lack of evidence on BVT as a treatment of multiple sclerosis deters us from reaching any determination. There also lacks firm evidences of immune response regulative or anti inflammatory mechanism of BVT. No clinicla trial was found. Conculsion : This review raises the urgent need of study to provide scientific and clinical evidences.

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Literature Review for the Clinical Application of Dietary Supplements in Cellulite Treatment (셀룰라이트 치료 시 식이 보조제의 임상적 활용을 위한 문헌적 고찰)

  • Yun, Jung-Min;Lee, Jong-Soo
    • Journal of Korean Medicine for Obesity Research
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    • v.18 no.2
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    • pp.128-143
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    • 2018
  • Objectives: The purpose of this study is to investigate the efficacy and the mechanisms of dietary supplements in cellulite treatment, and then to provide the theoretical and clinical basis for the cellulite treatment in Korean Medicine. Methods: We searched for articles from Korea, China, and English electronic database (Koreanstudies Information Service System [KISS], National Digital Science Library [NDSL], KMbase, Research Information Sharing Service [RISS], Oriental Medicine Advanced Searching Integrated System [OASIS], National Assembly Library, Korean Traditional Knowledge Portal, Google scholar, PubMed, Scopus, China National Knowledge Infrastructure [CNKI]) until April 2018. We chose clinical trial studies by inclusion criteria through titles, abstracts and articles. Results: A total of 10 studies were selected through search. The experimental group had shown more effective cellulite improvement in 90% of studies. Also, improvement of symptoms related with cellulite like pain, edema, heaviness and increase of skin surface temperature were observed in experimental group. In addition, the density of connective tissues of the dermal layer was increased in experimental group. Conclusions: The use of dietary supplements in cellulite treatment is thought to be effective through mechanisms that antioxidant efficacy, microcirculation improvement, interstitial matrix improvement, diuretic effect, and skin metabolic activity effect.