• Title/Summary/Keyword: Pilot trial

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Pilot Clinical Trial to Evaluate the Efficacy of Acupuncture Therapy on TEWL and Skin hydration (침시술이 경피수분 손실량과 피부 수분함유량에 미치는 임상적 연구)

  • Park, Soo Yeon
    • Journal of Physiology & Pathology in Korean Medicine
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    • v.32 no.4
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    • pp.271-276
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    • 2018
  • The purpose of pilot clinical trial is to evaluate the efficacy and safety of acupuncture therapy on TEWL(Transepidermal Water Loss) and skin hydration. A total of 36 human who visited Dongshin University Oriental Medical Center from October 2nd, 2015 to July 31st, 2016 were included in the pilot clinical trial. Acupuncture therapy was performed at Gokji(LI11) and Daechu(GV14). We observed change of TEWL(Transepidermal Water Loss), skin hydration before and after acupuncture therapy. In the primary endpoint, index of TEWL showed a statistically significant decline($8.01{\pm}2.55{\rightarrow}6.58{\pm}1.97g/h/m2$, $7.40{\pm}2.65{\rightarrow}4.99{\pm}1.89g/h/m2$). Index of skin hydration showed statistical significance($52.83{\pm}6.53{\rightarrow}56.82{\pm}7.24$, $63.50{\pm}8.57{\rightarrow}64.96{\pm}8.48$). To evaluate the safety, vital sign check were conducted and showed no statistically significant result. And there were no severe adverse events during this study. According to the above pilot clinical trial, it is suggested acupuncture therapy were effective for skin moisturizing.

Pilot Clinical Trial to Evaluate the Efficacy of Needle-Embedding Acupuncture Therapy at Gokji(LI11) on TEWL (곡지혈 매선침 시술이 경피수분 손실량에 미치는 영향)

  • Lee, Ho Chan;Jung, Mi Young;Choi, Jung Hwa;Jeong, Min Yeong;Park, Soo Yeon
    • Journal of Physiology & Pathology in Korean Medicine
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    • v.32 no.4
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    • pp.291-297
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    • 2018
  • The purpose of pilot clinical trial is to evaluate the efiicacy and safety of Needle-Embedding acupuncture therapy on TEWL(Transepidermal Water Loss) and Skin hydration. A total of 24 human who visited Dongshin Oriental Medical Center from December 1st, 2016 to July 31st, 2017 were included in the pilot clinical trial. Needle-Embedding acupuncture therapy performed at Gokji(LI11). We observed change of TEWL(Transepidermal Water Loss), Skin hydration before and after Needle-Embedding acupuncture therapy. In the primary endpoint, index of TEWL showed a statistically insignificant decline ($8.5{\pm}2.12{\rightarrow}7.8{\pm}1.53g/h/m^2$). Index of skin hydration showed a statistically significant result ($38.2{\pm}6.77{\rightarrow}36.8{\pm}6.64$). To evaluate the safety, Adverse events and Vital sign check were conducted and there were no problem. And when the physical response, self-awareness, skin system, musculoskeletal pain, and other abnormal responses were assessed 60 minutes and 24 hours and 7 days after Needle-Embedding acupuncture therapy at Gokji(LI11) for stability assessment, Adverse events disappeared during a pilot clinical trial. According to the above pilot clinical trial, it is suggested Needle-Embedding acupuncture therapy were effective for Skin moisturizing and safe.

Design of Course Keeping Controller for RIB-type USV Using a Pilot's Steering Pattern (조종자 입력패턴을 활용한 RIB형 무인선의 침로제어기 설계)

  • Yun, Kun-Hang;Yeo, Dong-Jin;Yoon, Hyeon-Kyu
    • Journal of the Society of Naval Architects of Korea
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    • v.47 no.3
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    • pp.462-468
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    • 2010
  • A new course keeping controller for RIB(Rigid Inflatable Boat)-type USV(Unmanned Surface Vehicle) is developed using pilot's steering pattern. A pilot's simple steering pattern is found out from various course change tests. It is used to course keeping algorithm, suitable for large course change more than 60 degrees. To validate the course keeping controller, sea trial tests are conducted. From sea trial test, new course keeping controller shows good performance with less overshoot, maximum roll angle less than $20^{\circ}$, which makes it possible that fast course changes without slip motion of USV.

A randomized, double-blind, placebo-controlled pilot study to assess the effects of protopanaxadiol saponin-enriched ginseng extract and pectinase-processed ginseng extract on the prevention of acute respiratory illness in healthy people

  • Hwang, Jeong-Hwan;Park, Soo-Hyun;Choi, Eun-Kyung;Jung, Su-Jin;Pyo, Mi Kyung;Chae, Soo-Wan
    • Journal of Ginseng Research
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    • v.44 no.5
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    • pp.697-703
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    • 2020
  • Background: GS-3K8 and GINST, both of which are modified ginseng extracts, have never been examined in terms of their effectiveness for the prevention of acute respiratory illness (ARI) in humans. We conducted a pilot study to assess the feasibility of performing a large-scale, randomized, controlled trial. Methods: This study was a randomized, double-blind, placebo-controlled, pilot study at a single center from October 2014 to March 2015. The 45 healthy applicants were randomly divided into the GS-3K8 (n = 15), GINST (n = 15), and placebo groups (n = 15). The study drug was administered as a capsule (500 mg/cap and 3000 mg/day). GS-3K8 contained 6.31 mg/g of Rg1, 15.05 mg/g of Re, 30.84 mg/g of Rb1, 15.02 mg/g of Rc, 12.44 mg/g of Rb2, 6.97 mg/g of Rd, 1.59 mg/g of Rg3, 3.25 mg/g of Rk1, and 4.84 mg/g of Rg5. GINST contained 7.54 mg/g of Rg1, 1.87 mg/g of Re, 5.42 mg/g of Rb1, 0.29 mg/g of Rc, 0.36 mg/g of Rb2, 0.70 mg/g of Rd, and 6.3 mg/g of compound K. The feasibility criteria were the rates of recruitment, drug compliance, and successful follow-up. The primary clinical outcome measure was the incidence of ARI. The secondary clinical outcome measures were the duration of symptoms. Results: The rate of recruitment was 11.3 participants per week. The overall rate of completed follow-up was 97.8%. The mean compliance rate was 91.64 ± 9.80%, 95.28 ± 5.75%, and 89.70 ± 8.99% in the GS-3K8, GINST, and placebo groups, respectively. The incidence of ARI was 64.3% (9/14; 95% confidence interval [CI], 31.4-91.1%), 26.7% (4/15; 95% CI, 4.3-49.0%), and 80.0% (12/15; 95% CI, 54.8-93.0%) in the GS-3K8, GINST, and placebo groups, respectively. The average days of symptoms were 3.89 ± 4.65, 9.25 ± 7.63, and 12.25 ± 12.69 in the GS-3K8, GINST, and placebo groups, respectively. Conclusion: The results support the feasibility of a full-scale trial. GS-3K8 and GINST appear to have a positive tendency toward preventing the development of ARI and reducing the symptom duration. A randomized controlled trial is needed to confirm these findings.

Factor Analysis of Type I Osteoporosis and Evaluation on Tuna Bone Powder Compounds through Small Scale Pilot Study (I형 골다공증의 요인분석과 다랑어골분 복합제제의 pilot study를 통한 평가)

  • Chi Gyoo Yang;Kim Young Man
    • Journal of Physiology & Pathology in Korean Medicine
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    • v.18 no.1
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    • pp.93-100
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    • 2004
  • This study was carried out for analyzing pathological and epidemiological factors of osteoporosis and doing pilot test using trial compounds of tuna bone and oriental herbs based on the factors. Osteoporosis is originated from osteoblast, osteoclast, organic and inorganic factors etc. Therefore the pathology of osteoporosis is not simple because the cytokine, growth factors and hormones of the components are various a lot. Taking a view of epidemiological factors of type I osteoporosis, ageㆍmenarcheㆍcholesterolㆍBMI etc. have definite relation to them. So we can approach to aging or consumptive disease in oriental medicine, specifically differential diagnosis of blood depletion with deficiency of qi, deficiency of kidney, deficiency of yin, bony weakness etc. And it should be considered together with rules for maintaining good health or habit concomitantly. Therefore IL1ㆍ6 or TNF αㆍβ are generally used as molecular biological index for osteoblast and osteoclast because the most important index is bone mineral density and strength, but the factors like collagen and noncollagen protein must be accounted as biomarkers. Trial compounds generally showed favorable effects on accompanying subjective symptoms of osteoporosis in the pilot test for menopausal woman. But if she didn't have specific symptoms of osteoporosis there wasn't any specific change. And osteocalcin was increased in case of being under standard level, but wasn't changed in case of normal level. Therefore these trial compounds can be used as a funcdonal diet for type I osteoporotic patients or preventive measures.

Study on the ENC Sea Trial Plan (전자해도 실선시험에 관한 연구)

  • 서상현;이희용
    • Proceedings of the Korean Institute of Navigation and Port Research Conference
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    • 1998.10a
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    • pp.85-95
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    • 1998
  • ECDIS, highlihgted as a new technology for the navigation safety, could replace the paper charts in the bridge and make the more safe navigation possible. For the marines to use the ECDIS, the infrastructrue of the ENC production and distribution, the development of IMO compliant ECDIS, the training program for the ECDIS usage and related matters are thought as the key points to be solved. Also it is necessary for the ECDIS usage and related maters are thought as the key point to be solved. Also it is necessary for the related groups, such as ECDIS manufactures, users, ENC producers, the to be involved in developing the national infrastructure altogether to promote the ECDIS usage. Upon these background, the Korean ENC pilot project was introduced and the comparison study of the SHARED project coordinated by MPA(Maritime Port Authority, Singapore) and the Canadan Pilot project has been done. With such a analysis, the Korean ENC sea trial test plan is presented.

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Decontamination Performance Assessment for the Plasma Arc Vitrification pilot plant on the basis of Trial Burn Results(I) - Decontamination Characteristics for Hazardous Metal, Radioactive surrogate and Radioactive Tracer in Off-gas (시험연소결과에 근거한 플라즈바 아크방식 유리화 시험 설비의 제염성능 평가(I) - 배기가스중의 유해중금속, 방사성핵종 모의물질 및 방사성핵종 제염특성 -)

  • Chae, Gyung-Sun;Park, Youn-Hwan;Min, Byong-Yun;Chang, Jae-Ock;Park, Jun-Yong;Jeong, Weon-Ik;Moon, Byung-Sik
    • Journal of Radiation Protection and Research
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    • v.25 no.2
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    • pp.99-107
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    • 2000
  • Through the results of off-gas analysis at 3 sampling points in Plasma Arc Melting vitrification pilot plant, it was evaluated the partitioning of spiked materials in off-gas and the decontamination characteristic of off-gas treatment system. Spiked materials are hazard_us heavy metals(Pb, Cd, Hg), radioactive surrogate(Co, Cs) and radioactive materials($^{60}Co,\;^{137}Cs$). Through the Trial burn tests, Decontamination factor of spiked materials in off-gas treatment system is calculated.

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Efficacy of Electroacupuncture using an Insulated Needle in Adults with Abdominal Obesity: A Pilot Study

  • Oh, Seo Young;Lee, Hyun;Yun, Gee Won;Kang, Jae Hui
    • Journal of Acupuncture Research
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    • v.34 no.2
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    • pp.49-59
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    • 2017
  • Objectives : This study evaluated the efficacy of electroacupuncture therapy using an insulated needle in adults with abdominal obesity. Methods : This study was a randomized, double-blind, parallel-designed pilot trial. Sixteen participants eligible according to the inclusion and exclusion criteria were randomly divided into an insulated needle group and a control group. Insulated or common needles were inserted at acupoints located on the abdomen (CV12, CV6, ST25, ST27, SP15) and were electrically stimulated for 30 minutes (16 Hz, within tolerable strength). A total of 10 sessions of treatment were performed twice per week for 5 weeks. All participants were requested to maintain their usual diet and lifestyle. The outcome measures were waist circumference (WC), waist-to-hip ratio (WHR), and abdominal computed tomography (CT) of the total fat area (TFA), subcutaneous fat area (SFA), and visceral fat area (VFA). Results : A total of 12 participants divided into the insulated needle group (n = 5) and the control group (n = 7; common needle) were treated for 10 sessions and analyzed per-protocol (PP). WC decreased significantly after 10 sessions in both groups. The WC, TFA, SFA, and VFA of abdominal CT in the insulated needle group decreased more than in the control group; however, there were no significant differences in any parameter between the insulated needle group and the control group. Patients in the insulated needle group were more strongly stimulated with electrical stimulation than patients in the control group. Conclusion : Electroacupuncture using insulated needles in adults with abdominal obesity might be a more effective treatment than common needles. Additional studies are required to compensate for the limitations of this pilot study and to verify the results and efficacy.

Acupuncture for Chronic Fatigue Syndrome and Idiopathic Chronic Fatigue : a Protocol for a Pilot Randomized Controlled Trial (만성피로증후군과 특발성 만성피로에 대한 침 치료의 유효성 및 안전성 평가 : 무작위 대조 예비 임상연구 프로토콜)

  • Kim, Jung-Eun;Kang, Kyung-Won;Kim, Tae-Hun;Jung, So-Yong;Kim, Ae-Ran;Shin, Mi-Suk;Park, Hyo-Ju;Hong, Kwon-Eui;Choi, Sun-Mi
    • Korean Journal of Acupuncture
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    • v.28 no.3
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    • pp.151-163
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    • 2011
  • Objectives : Our aim is to evaluate feasibility for massive clinical research and to make basic analysis of efficacy and safety of acupuncture treatment for chronic fatigue syndrome and idiopathic chronic fatigue. Methods : This study is a protocol for a pilot randomized controlled trial. It was developed through literature searches and discussions among researchers. Results : Forty participants allocated to acupuncture group and wait-list group. Participants allocated to acupuncture group will be treated three times per week for a total of 12 sessions over four weeks. Eight points (GV20; bilatral GB20, BL11, BL13, BL15, BL18, BL20, BL23) have been selected for the acupuncture group. Participants in the wait-list group will not receive acupuncture treatment during study period and follow-up will be made in the 5th and 9th weeks after random allocation. Then the same acupuncture treatment as that performed to the acupuncture group will be made to the wait-list group. Fatigue Severity Scale, a short form of Stress Response Inventory, Beck Depression Inventory, and Insomnia Severity Index will be used as outcome variables to evaluate the efficacy of acupuncture. Safety will be assessed at every visit. Conclusions : The trial based on this study will be performed. The results of the trial will provide basis for the efficacy and safety of acupuncture treatment for chronic fatigue syndrome and idiopathic chronic fatigue.

Efficacy and Safety of Geochangmanryeung-dan and Acupuncture on Patient with Spinal Stenosis Treated by Epidural Steroid Injection: a Study Protocol for a Randomized Controlled Pilot Trial (경막외신경차단술로 치료 중인 척추관 협착증 환자에서 거창만령단과 침의 효능 및 안전성 연구(예비임상연구))

  • Lee, Hyun-jong;Lee, Cho In;Lee, Saram;Kwak, Min-Ah;Kwak, Sang Gyu;Roh, Woon-seok;Jung, Jin-yong
    • Korean Journal of Acupuncture
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    • v.32 no.3
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    • pp.99-107
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    • 2015
  • Objectives : This study was designed to obtain basic data for a further large-scale trial as evaluating the efficacy and safety of Geochangmanryeung-dan(GMD) and acupuncture on patient with spinal stenosis treated by epidural steroid injection. Methods: The study is a randomized controlled pilot clinical trial, conducted over 8 weeks. Twenty participants will be recruited and randomly allocated to 2 groups: an experimental(GMD and acupuncture with epidural steroid injection) group and a control(only epidural steroid injection) group. The epidural steroid injection will be administered once per 2 weeks for 6 weeks(3 times in total). GMD will be administered as a dose of 5 pills, 3 times per day, for 6 weeks. Acupuncture will be performed 2 times per week for 6 weeks(12 times in total). The primary outcome will be measured by visual analogue scale and self-rated walking distance. The secondary outcome will be measured by PainVision, short-form McGill Pain Questionnaire, and Oswestry Disability Index. Both primary and secondary outcomes will be measured at baseline, 2, 4, 6, and 8 weeks. The last assessment(at 8 weeks) will be performed 2 weeks after treatment cessation. Conclusions : This clinical trial, as the pilot study for a future large-scale trial, will provide clinical information for evaluating the efficacy and safety of GMD and acupuncture treatment in combination with epidural steroid injection for the treatment of spinal stenosis.