• 제목/요약/키워드: Pilot clinical trial

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육미지황탕증(六味地黃湯證)의 병인논(病因論)적 분석을 위한 설문문항(說問問項) 개발(開發) (Development of Questionnaires for Pathogenesis Analysis of Yukmijiwhang-tang Symptom)

  • 조상원;박영재;김민용;오환섭;박영배
    • 대한한의진단학회지
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    • 제12권2호
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    • pp.61-73
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    • 2008
  • Background: Yukmijiwhang-tang is one of the most common herbal formulas in Oriental Medicine. Yukmijiwhang-tang has been widely used as a herbal medicine to replenish Yin and tonify the kidneys for hundred years in Asian countries. Because of insufficiency in data, objective judgements about remedial effects have been difficult. In order to make objectivity diagnostic data, this research is developed. Purpose: The aim of the research is to make a pilot questionnaire for clinical use of Yukmijiwhang-tang. Methods: The questionnaire which includes symptoms and signs for Yukmijiwhang-tang is studied by the Delphi method. Results: By the Delphi method and score evaluation, 30 items of the initial copy of questionnaire are chosen for the research. Conclusions: By the Delphic survey among clinicians, a reference questionnaire for Yukmijiwhang-tang applications was suggested. Further research is necessary for modification of questionnaire by statistics and certification by clinical trial. research.

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퇴행성 슬관절염 환자에 대한 도침요법의 효능 및 안전성 연구: 임상예비연구 (Efficacy and Safety of Miniscalpel Acupuncture in Knee Degenerative Osteoarthritis Patients: A Study Protocol for a Randomized Controlled Pilot Trial)

  • 전승아;박무섭;오세정;이정희;공한미;최성훈;황보민;이현종;김재수
    • Korean Journal of Acupuncture
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    • 제33권2호
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    • pp.67-74
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    • 2016
  • 목적 : 본 연구는 퇴행성 슬관절염 환자들을 대상으로 도침치료가 통증을 감소시키는데 효과적이고 안전한 치료법임을 증명하기에 적합한지를 알아보기 위한 예비연구이다. 방법 : 본 연구는 5주간 진행되는 무작위배정 대조군 예비임상연구이며, 총 20명의 피험자들은 시험군(도침치료)과 대조군(침치료+전침치료)으로 무작위 배정된다. 시험군의 경우에는 주 1회, 3주간 총 3회의 도침치료를 실시하고 대조군의 경우에 주 2회, 3주간 총 6회의 침치료와 전침치료를 받게된다. 1차 유효성 평가변수는 통증에 대한 Visual analogue system와 관절가동범위를, 2차 유효성 평가변수는 Short form McGill pain questionnaire와 Western Ontario and McMaster Universities Osteoarthritis Index로 측정한다. 평가는 시험시작 전, 시험 1주, 2주, 3주 및 5주후에 이루어지게 된다. 결론 : 본 연구는 추후 본격적인 무작위배정 대조군 임상시험을 위한 예비연구로서, 본 연구를 통해 퇴행성 슬관절염에 있어서 도침치료가 임상적으로 유효함을 증명할 수 있는 근거를 마련해 줄 것이라 사료된다.

Efficacy and Safety of Miniscalpel Acupuncture on Knee Osteoarthritis - A randomized controlled pilot trial -

  • Jun, Seungah;Lee, Jung Hee;Gong, Han Mi;Choi, Seong Hun;Bo, Min Hwang;Kang, Mi Suk;Lee, Geon-Mok;Lee, Hyun-Jong;Kim, Jae Soo
    • 대한약침학회지
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    • 제21권3호
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    • pp.151-158
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    • 2018
  • Objectives: We investigated the efficacy and safety of miniscalpel acupuncture (MA) for knee osteoarthritis (KOA) in an assessor-blinded randomized controlled pilot trial; this would provide information for a large-scale randomized controlled trial. Methods: Participants (n = 24) were recruited and randomly allocated to the MA group (experimental) or acupuncture group (control). The MA group received treatment once a week for 3 weeks (total of 3 treatments), while the acupuncture group received treatment two times per week for 3 weeks (total of 6 treatments). The primary outcome was pain as assessed by a visual analogue scale (VAS). The secondary outcomes (intensity of current pain, stiffness, and physical function) were assessed using the short-form McGill Pain Questionnaire (SF-MPQ) and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Assessments were performed at baseline, 1, 2, and 3 during treatment and at week 5 (2 weeks after the end of treatment). Results: Of the 24 participants, 23 completed the study. Both groups showed significant improvements in VAS, SF-MPQ, and WOMAC. However, there were no significant differences between the MA and acupuncture groups. No serious adverse event occurred and blood test results were within normal limits. Conclusion: Our results suggest that although both MA and acupuncture provide similar effects with regard to pain control in patients with KOA, MA may be more effective in providing pain relief because the same relief was obtained with fewer treatments. A large-scale clinical study is warranted to further clarify these findings.

침치료가 폐암 환자의 피로도에 미치는 영향: Pilot Study (The Effectiveness of Acupuncture for Fatigue Severity in Lung Cancer Patients: Pilot Study)

  • 현대성;김종대;권효정;정현정
    • Korean Journal of Acupuncture
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    • 제29권4호
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    • pp.623-633
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    • 2012
  • Objectives : Fatigue is a common and distressing symptom that is a concern for cancer patients. It has a decisive effect on quality of life. The purpose of this study was to examine the feasibility of clinical trial to evaluate of efficacy and safety of acupuncture on cancer related fatigue of lung cancer patients. Methods : Total lung cancer 9 patients complained of fatigue were treated by acupuncture twice a week for four weeks(8 times in total). Evaluation of the severity of fatigue was measured by FSS(Fatigue Severity Score). In visit 1, 10, we checked FSS. For check safety of acupuncture treatment, we did blood test. Results : After 4 weeks of acupuncture treatment, the FSS was significantly decreased from $4.92{\pm}1.06$ to $3.74{\pm}1.37$(p=0.008). And the level of hemoglobin was significantly increased from 10.87 g/dl to 12.01 g/dl(p=0.014). No other lab measures indicated any significant differences between before and after acupuncture treatment. Conclusions : This study suggests that acupuncture treatment will be beneficial for lung cancer patients to improve the fatigue severity. And acupuncture treatment is safe method for lung cancer patients. A large-scale study to confirm efficacy and safety of acupuncture is needed.

냉온 부하에 따른 요골동맥 맥파의 변화 특성을 파악하기 위한 무작위 배정·2×2교차설계 탐색적 임상시험계획서 개발 (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)

  • 유하나;김지혜;구본초;김현호;전영주
    • 대한한의진단학회지
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    • 제19권2호
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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.

급성 족관절 염좌에 대한 봉약침 효과-무작위대조시험, 이중맹검 (The Effect of Bee Venom Acupuncture(BVA) on acute Ankle Sprain : A Randomized Controlled Trial and double blinding - Pilot study)

  • 송호섭
    • 대한약침학회지
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    • 제8권2호
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    • pp.11-16
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    • 2005
  • Objective : The aim of the study was to investigate the therapeutic effect of BVA in the treatment of patients with acute ankle sprain. Design : A prospective randomized double-blind study of BVA was conducted. Setting : The study was done in the Kyungwon University Seoul Hospital from August 1st, 2004 to June 15th, 2005. Patients : 30 patients diagnosed with acute ankle sprain, especially 2nd degree on the Ankle grade pain chart(AGPC) participated in the study, who were divided into two groups (A and B) randomly by a coordinator flipping a coin. Group A and B were relevant to control and BVA group respectively, of which a coordinator never informed any other participant involved. Eventually 13 of 17 in group A and 11 of 13 in Group B finished all the process of the clinical trial. Intervention : In both group A and B, The Procedure of acupuncture treatment was made similar by appearance that four acupoints such as 坵墟(GB40), 中封(LR4), 商丘(SP5), 解谿(ST41) of the injured side were selected and Normal saline aqua-acupuncture(control, as a placebo) or BVA was done and then acupuncture at 坵墟(GB40), 中封(LR4), 商丘(SP5), 解谿(ST41), 足三里(ST36), 陽陵泉(G34) of the affected side was given again. the needles were retained for 20 minutes under the infrared rays. The treatment was given daily for a week. Outcome Measures : Ankle-Hindfoot Scale (AHS) and Visual Analogue Scale(VAS) were followed by three treatments. Statistical Analysis : Analysis regarding variations in AHS and VAS is carried out by applying Mann-Whitney test and Wilcoxon signed rank test sign test with level of significance at 5%. Results : At the end of the treatment, there was significant statistical differences between the two groups in VAS and AHS as well, while at the 3rd day only a VAS showed statistical significance. In each group, both VAS and AHS showed statistical significance along with duration of treatment. Conclusions : BVA was thought to be effective alternatives for relieving symptoms of acute ankle sprain, although further study was needed on the large scale.

Efficacy of Roflumilast in Bronchiectasis Patients with Frequent Exacerbations: A Double-Blinded, Randomized, Placebo-Controlled Pilot Clinical Trial

  • Juthong, Siwasak;Panyarath, Pattaraporn
    • Tuberculosis and Respiratory Diseases
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    • 제85권1호
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    • pp.67-73
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    • 2022
  • Background: Bronchiectasis patients with neutrophilic airway inflammation develop symptoms of chronic cough, sputum production, and recurrent exacerbations. Roflumilast has anti-inflammatory actions via decreased neutrophilic airway inflammation. The effectiveness of roflumilast to reduce bronchiectasis exacerbation has never been evaluated. Methods: We conducted a double-blinded, randomized, placebo-controlled trial. Our primary objective was to assess the effect of roflumilast compared with that of a placebo in reducing exacerbation rates in bronchiectasis patients. The secondary objectives were the changes in forced expiratory volume in 1 second (FEV1) and St. George's Respiratory Questionnaire (SGRQ). Bronchiectasis patients older than 18 years who had had two exacerbations during the previous 12 months were randomly assigned to receive either 500 ㎍ of either roflumilast or a placebo once daily for 6 months in a 1:1 ratio. Results: Forty bronchiectasis patients who had experienced exacerbations were screened. Thirty patients completed the study after 6 months of treatment: roflumilast group (n=15) and placebo group (n=15). The rates of exacerbations were 0.57 and 0.59 per patient in the roflumilast and placebo groups, respectively. Prebronchodilator FEV1 increased by 0.07 L from baseline in the roflumilast group and decreased by 0.015 L in the placebo group, but the difference was not significant. No significant differences were observed in the change of SGRQ scores between the roflumilast and placebo groups. Roflumilast had significant side effects, including loss of appetite and headache. Conclusion: Roflumilast did not significantly affect the rate of exacerbations or quality of life. However, FEV1 tended to improve more in the roflumilast group than in the placebo group.

Micronutrients and superoxide dismutase in postmenopausal women with chronic periodontitis: a pilot interventional study

  • Daiya, Sunita;Sharma, Rajinder Kumar;Tewari, Shikha;Narula, Satish Chander;Sehgal, Paramjeet Kumar
    • Journal of Periodontal and Implant Science
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    • 제44권4호
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    • pp.207-213
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    • 2014
  • Purpose: The study was aimed at investigating changes in periodontal parameters and superoxide dismutase activity triggered by root surface debridement with and without micronutrient supplementation in postmenopausal women. Methods: Forty-three postmenopausal chronic periodontitis patients were divided into two groups: group 1 (n=22) were provided periodontal treatment in the form of scaling and root planing (SRP) and group 2 (n=21) patients received SRP along with systemic administration of micronutrient antioxidants. Patients in both groups were subjected to root surface debridement. Group 2 patients also received adjunctive micronutrient antioxidant supplementation. Serum and salivary superoxide dismutase (SOD) activity along with periodontal parameters were recorded at baseline and 3 months after therapy. Results: Salivary and serum SOD values significantly (P<0.05) improved with periodontal treatment. Improvement in systemic enzymatic antioxidant status along with reduction in gingival inflammation and bleeding on probing (%) sites was significantly greater in group 2 as compared to group 1. Conclusions: Adjunctive micronutrient supplements reduce periodontal inflammation and improve the status of systemic enzymatic antioxidants in postmenopausal women.

The effects of vibration stimulation applied to the left forearm on unilateral neglect in patients with stroke: A pilot randomized controlled trial

  • Park, Jin-hyuck;Park, Ji-hyuk
    • 재활치료과학
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    • 제4권2호
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    • pp.63-71
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    • 2015
  • Objective : The purpose of this study was to investigate the effects of vibratory stimulation applied to the left forearm on unilateral neglect in patients with stroke. Methods : The subjects were 11 unilateral neglect patients with stroke. They were divided into 2 groups; 6 experimental subjects and 5 control subjects. Both groups received standardized rehabilitation program and occupational therapy for the intervention of unilateral neglect in a day. In random order, line bisection test (LBT), Albert test, and star cancellation test (SCT) were conducted at baseline, the next day. During the process of all assessments of the next day, vibration stimulation was provided for the 6 subjects in the experimental group (EG), while the 5 subjects in CG carried out all assessments without vibration stimulation. Result : No significant differences were found between groups on any demographic variable or baseline assessments scores. In the next day, there was significant improvement in the EG for the LBT(p<0.05), Albert's test(p<0.05), and SCT(p<0.05). However, there was no significant improvement in the CG for the LBT(p<0.05), Albert's test(p<0.05), and SCT(p<0.05). Conclusion : These result indicate that vibratory stimulation has a positive effect on the unilateral neglect, and may be considered as alternative choice in clinical occupational therapy for reducing unilateral neglect.

다발성감각운동자극 치료가 뇌졸중 환자의 보행과 낙상위험도에 미치는 효과: 무작위배정예비임상시험 (Effect of Multi-Sensorimotor Training on Gait Ability and Fall Risk in Subacute Stroke Patients: A Randomized Controlled Pilot Trial)

  • 임재길
    • 대한통합의학회지
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    • 제7권2호
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    • pp.19-29
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    • 2019
  • Purpose : To determine whether an advanced rehabilitation therapy combined with conventional rehabilitation therapy consisting of sensorimotor exercises that would be superior to a usual treadmill training in gait ability and fall risk in subacute stroke patients. Methods : Thirty subjects randomly assigned to either multi-sensorimotor training group (n=19) or treadmill training group (n=18). Both groups first performed conventional physical therapy for 30 min, after which the multi-sensorimotor training group performed multi-sensorimotor training for 30 min, and the treadmill training group performed treadmill gait training for 30 min. Both groups performed the therapeutic interventions 5 days per week for 8 weeks. Gait ability was evaluated using the GAITRite system and Fall risk was measured using the Biodex Balance system before intervention and after 8 weeks. Results : There were no intergroup differences between demographic and clinical characteristics at baseline (p>.05). Both groups showed a significant improvement in gait ability (p<.05) and Fall risk (p<.05). In particular, the multi-sensorimotor training group showed more significant differences in gait velocity (p=.05), step length (p=.01) and stride length (p=.014) than the treadmill training group. Conclusion : The multi-sensorimotor training program performed on multiple types of sensory input had beneficial effect on gait ability. A large-scale randomized controlled study is needed to prove the effect of this training.