• Title/Summary/Keyword: preliminary clinical trial

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Development of Clinical Protocol for Acquisition of Change of Radial Pulse Wave Signal in the Cold-Heat Intervention: Explanatory, Randomized, 2×2 cross-over design (냉온 부하에 따른 요골동맥 맥파의 변화 특성을 파악하기 위한 무작위 배정·2×2교차설계 탐색적 임상시험계획서 개발)

  • Yu, Hana;Kim, Jihye;Ku, Boncho;Kim, Hyunho;Jeon, Youngju
    • The Journal of the Society of Korean Medicine Diagnostics
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    • v.19 no.2
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    • pp.91-100
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    • 2015
  • Objectives The aim of this study is to develop a structured clinical protocol related with acquisition of radial pulse wave in the randomized, $2{\times}2$ cross-over design, and cold-heat intervention trial for a pilot and preliminary study. Methods The protocol was contrived based on wide ranging literature searches for cold-heat intervention experiments and radial pulse diagnoses. Results Sample size of 60 subjects was calculated based on an effect size derived from the previous study designed to detect the pre-post cold-heat differences in the radial pulse. Each subjects will be randomly assigned to the cold (first) to heat (last) group (n=30) or heat (first) to cold (last) group (n=30). All subjects will fill out a case report form and questionnaires related with pattern identification, dietary patterns, sleep quality, and physical activity will be surveyed and used as a secondary outcomes. Safety assessment will be reported at the final stage. Conclusions This protocol will provide an additional reference to future studies related with observation of radial pulse during any interventions and also expect to be used as a guideline for acquisition of reliable radial pulse wave data.

Antihyperlipidemic and Antioxidant Effects of the Mixture of Ginseng Radix and Crataegi Fructus: Experimental Study and Preliminary Clinical Results

  • Ko, Chang-Nam;Park, Seong-Uk;Chang, Gyu-Tae;Jung, Woo-Sang;Moon, Sang-Kwan;Park, Jung-Mi;Cho, Ki-Ho
    • Journal of Ginseng Research
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    • v.35 no.2
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    • pp.162-169
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    • 2011
  • The mixture of Ginseng Radix and Crataegi Fructus (Gen-CF) was developed to increase the pharmacological effect of ginseng in the treatment of hypercholesterolemia and prevention of cardiovascular disease. This study evaluated the effects of Gen-CF on serum lipids of hypercholesterolemic rats in vivo, as well as its antioxidant activities in vitro, and explored its clinical effects on patients with hypercholesterolemia. In vitro, Gen-CF displayed 1,1-diphenyl-2-picrylhydrasyl and superoxide radical scavenging activities, and inhibited hemolysis induced by 2,2'-azobis-2-amidinopropane dihydrochloride in a dose-dependent manner. In vivo, Gen-CF significantly inhibited the increases of total cholesterol, low-density lipoprotein cholesterol and triglyceride in high cholesterol-diet and Triton WR-1339 models. It also significantly inhibited the decrease of high-density lipoprotein cholesterol in these models. In the clinical trial, Gen-CF significantly lowered total cholesterol, low-density lipoprotein cholesterol, triglyceride, total lipid and phospholipid, with no adverse events, including hepatic or renal toxicity. The data suggest that Gen-CF has the potential to treat hypercholesterolemia and prevent cardiovascular disease.

Adaptation of the Evidence Based Nursing Practice Guideline (근거중심 급성 뇌졸중 간호 가이드라인 수용개작)

  • Kim, Ji Hyun;Song, So Lee;Kim, Mi Kyung;Cho, Myoung Sook
    • Journal of Korean Clinical Nursing Research
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    • v.17 no.2
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    • pp.176-191
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    • 2011
  • Purpose: This methodological study translated, adapted, and validated the evidence based guideline of RNAO (Registered Nurses Association of Ontario) in Canada, for acute stroke care to domestic circumstances. Methods: Quality of the RNAO guideline was evaluated using AGREE tool. Then the guideline was translated into Korean and a preliminary guideline was established After checking content validation by an expert group, the Korean version of the guideline was applied to clinical settings to see its applicability. Results: The RNAO guideline in Korea was deemed appropriate. The Korean version of the guideline was drawn up with 56 items in 3 areas in stroke system related nursing, nursing of acute stroke inpatients, and stroke nursing assessment. A questionnaire survey was performed on appropriateness, enforceability, and applicability of those recommendations. A total of 54 recommendations were finalized after deleting 2 items below CVI 0.7 and correcting 3 items by taking professional advices. After trial application of the guideline to 40 stroke patients hospitalized at a ward of a hospital in Seoul, its performance was improved but was not statistically significant. Conclusion: This guideline is expected to contribute to improving nursing quality by offering it as a guide to evidence based practices for acute stroke care in Korea.

The Influence of Skin surface temperature on Transdermal Absorption of Active Substances and Changes in Skin Condition (피부표면온도가 유효물질 경피 흡수 및 피부 상태변화에 미치는 영향)

  • Kwon, Hye-Jin;Han, Sa-Ra;Jung, Na-Seul
    • Journal of the Korean Applied Science and Technology
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    • v.36 no.1
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    • pp.299-304
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    • 2019
  • This study was conducted to investigate the effects of skin surface temperature on transdermal absorption of active substances and changes in skin condition. A transdermal absorption test was conducted using an emulsion containing 10% heat-resistant niacinamide, and the same emulsion was used in a clinical trial to test the thermal effects. As a result, absorption was found to be 2 times greater at 10 minutes and 3 times greater at 15 minutes after application at $42^{\circ}C$ than that of compared to normal skin temperature. During the clinical evaluation on skin, no clinical subjects showed any specific adverse reactions, while moisture and oiliness showed statistically significant effects at higher temperatures. Based on these results, it was confirmed that thermal warmer improves the absorption of active substances and had a positive effect on skin condition. It is deemed that this study will provide a preliminary data to support the development of various beauty devices using heat.

Preliminary Study to Develop the Instrument of Oriental Medical Evaluation for Hwa-Byung (화병 한의 평가도구 개발을 위한 기초 연구)

  • Cheong, Myung-Hee;Lee, Sang-Ryong;Kang, Wee-Chang;Jung, In-Chul
    • Journal of Oriental Neuropsychiatry
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    • v.21 no.2
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    • pp.141-155
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    • 2010
  • Objectives : This study was performed to develop a standard instrument of oriental medical evaluation for hwa-byung. Methods : The advisor committee on this study was organized by 17 neuropsychiatry professors of oriental medical colleges. The items and structure of the instrument were quoted from the instrument of pattern identification for hwa-byung. We took consultation twice from the advisor committee and we also took additional advices by e-mail. Results : We discriminated between bian-zheng and su-zheng from the answers of the advisor committee. We got the mean weight of each symptom and sign from the answers of the advisor committee. We got the final weight from the combination of the ratio of bian-zheng to the number of all answers of the advisor committee and mean weight. Conclusions : The instrument of oriental medical evaluation for hwa-byung was developed through experts' discussion. If the validity and reliability of this instrument is confirmed through additional clinical trial, the instrument of oriental medical evaluation for hwa-byung is expected to be applied to the subsequent research.

Clinical Applications of Microwave and Ultrasound in Hyperthermia: Preliminary Results (극초단파와 초음파온열치료에 의한 각종암의 임상치료)

  • Koh Kyoung Hwan;Park Young Hwan;Cho Chul Koo;Yoo Seong Yul
    • Radiation Oncology Journal
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    • v.6 no.1
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    • pp.75-80
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    • 1988
  • Twenty seven lesions of 25 patients with locally advanced malignant tumors were treated with combined hyperthermia introduced by microwave and ultrasound and radiotherapy. Most of all patients were failed with previous conventional therapeutic trial. Hyperthermia had been done immediately after radiotherapy, twice a week, $43^{\circ}C$ for one hour and radiotherapy had been done 5 fractions per week with fraction size of 2Gy upto 30 to 60Gy. Conclusions are as follows. 1. Total response rate (PR+PR) to thermoradiotherapy with microwave and ultrasound was $81\%$. 2. Tumor depth, minimum temperature of tumor center, number of heat fraction and radiation dose were statistically significant factors affecting response. 3. Hyperthermia with microwave and ultrasound can be used efficiently to control locally advanced malignant disease whether previously received near tolerance dose of radiotherapy or not.

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Systematic Review of Fire Needling or Warm Needling Treatment for Ankle Sprain

  • Ko, Hong Je;Yoo, Jae Hee;Kim, Min Wook;Shin, Jeong Cheol
    • Journal of Acupuncture Research
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    • v.37 no.1
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    • pp.19-27
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    • 2020
  • The effectiveness of fire needling or warm needling treatment in clinical studies for the treatment of ankle sprains was reviewed using 4 international (PubMed, Cochrane library, EMBASE, CNKI) and 5 Korean databases (NDSL, RISS, KISS, OASIS, KTKP). Randomized controlled trials, that performed fire needling or warm needling treatment for ankle sprains until October, 2018 were retrieved (n = 8). All studies were performed in China, and 7 out of 8 studies were published within the last 5 years. There were 4 studies that used fire needling treatment, 3 studies used warm needling treatment, and 1 study used fire and warm needling treatment. The ashi-points and gallbladder meridian were the most frequently selected acupoint and meridian each. All intervention groups in the 8 studies showed statistically significant beneficial effects compared with control groups. The results of this study could provide preliminary data as the basis for well-designed randomized controlled trials on fire needling or warm needling treatment for ankle sprains.

Therapeutic Feasibility Study and Clinical Trial of Intrahepatic $I^{-131}-Lipiodol$ on Patients with Hepatocellular Carcinoma ($Lipiodol-I^{-131}$의 경간동맥 주입에 의한 간암치료의 가능성에 관한 연구)

  • Yoo, Hyung-Sik;Suh, Jung-Ho;Lee, Jong-Tae;Kim, Dong-Ik;Park, Chang-Yun;Kim, Byung-Soo;Park, Chan-H.;Thakur, M.
    • The Korean Journal of Nuclear Medicine
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    • v.20 no.2
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    • pp.61-71
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    • 1986
  • An iodized oil such as Ethiodol or Lipiodol was selectively retained in the tumor vessels of the large hepatomas as well as in the small daughter hepatomas for long periods following the intra-arterial hepatic injection of such contrast material. The specific aim of the study is to deliver a high internal radiation dose to hepatocellular carcinoma (HCC) in an attempt to control the disease. We were able to replace a small fraction of the stable iodine (I-127) of the 37% iodine in Lipiodol by the $I^{-131}$ with 100% exchange efficiency. $I^{-131}$ labeled Lipiodol was injected through the super-selected tumor feeding artery under superselection or into the proper hepatic arterial level of patients who have malignant hepatomas confirmed by aspiration cytology serum AFP and various imaging modalities. Clinical traial was performed on 43 cases during recent 6 months and follow-up observation was carried out. No severe complications or other adverse reactions were encountered until nowdays. $I^{-131}-Lipiodol$ was stable in vivo and no significant activity was noted in the thyroid, stomach, blood and urine after the injection. Only small fraction of radioisotope activity was noticed in the both side of lungs. Tumor to normal liver radio was very high. Therefore, $I^{-131}-Lipiodol$ (or P-32-Lipiodol) will be effective delivering high internal radiation dose to the tumor while delivering small radiation doses to normal tissues. Labeling, tumor dose calculation and preliminary findings will be presented.

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Preliminary Study to Develop the Instrument on Pattern Identifications for Depression (우울증 변증도구 개발을 위한 기초연구)

  • Lee, Eun Hee;Choi, Woo Chang;Jung, In Chul
    • Journal of Oriental Neuropsychiatry
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    • v.24 no.4
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    • pp.435-450
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    • 2013
  • Objectives: The purpose of this study is to develop a standard tool for pattern identifications in Korean Medicine for depression. Methods: The advisor committee for this study was organized by 15 Korean Medicine neuropsychiatry professors from 11 Colleges of Korean Medicine. The items and structure of the tools were based on reviews of published literature. In order to develop the tool, we took the consultation from discussions with the advisor committee twice and also incorporated additional advices from e-mail correspondences. Results: 1) We divided the symptoms and signs of depression into 11 pattern identifications. 2) We obtained the mean weights which reflected the standard deviations from each symptoms of the 11 pattern identifications which were scored on a 100-point scale by 15 experts. 3) We designed the Korean medicine pattern identification tool for depression. It was composed of 66 questions in the question- and-answer format. Conclusions: There are some points which should be considered in this study. First, we couldn't reach a complete agreement on the concept of 11 patterns. Second, each pattern identification has a different number of symptoms and signs. In addition, the items of symptoms and signs of each pattern identification are unequal. Third, as we did not set any clinical trials when using this tool, it was not possible to test its validity and reliability. Although there are some limits in this study, the development of pattern identification tools for depression through discussions with the advisor committee is meaningful. If the validity and reliability of the Korean Medicine pattern identification tools for depression are confirmed through clinical trial,s this tool is expected to be applied to the subsequent researches in the future.

The Effect of Omega-3 Fatty Acid Supplementation on Cerebral Blood Flow and Vascular Resistance: A Preliminary Study (오메가 3 지방산이 뇌혈류 및 혈관저항에 미치는 영향: 예비연구)

  • Heo, Jae-Hyeok;Won, Hye-Yeon;Im, Dong-Gyu;Kim, Jung-Hee;Kim, Hee-Tae;Ahn, Jin-Young
    • Annals of Clinical Neurophysiology
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    • v.17 no.2
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    • pp.68-72
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    • 2015
  • Background: The effects of omega-3 polyunsaturated fatty acids (PUFAs) on cerebral vessels have not been clarified until now. Thus we investigated the efficacy of omega-3 PUFAs supplementation on cerebral blood flow velocity and vascular resistance via transcranial doppler (TCD). Methods: Consecutive twenty patients (13 male and 7 female) with at least 1 cerebrovascular risk factor or a known cerebrovascular disease were enrolled. Patients were treated with omega-3 PUFAs (1 g, two times per day) for 12 weeks. Cerebral blood flow velocity, resistance index, and pulsatile index were checked before and after 12 weeks of treatment using TCD. Results: The change of resistance index in right MCA (from $0.58{\pm}0.07$ to $0.55{\pm}0.07$, p = 0.042) and left PCA (from $0.56{\pm}0.07$ to $0.53{\pm}0.06$, p = 0.037) showed significant improvement after 12 weeks of omega-3 PUFAs treatment. The changes in other vessels, however, failed to show any significant changes compared to the baseline. Conclusions: Omega-3 PUFAs treatment showed feasible efficacies for cerebral vascular resistances in this open label trial. To confirm these results, larger samples of patients and longer period of follow-up is warranted.