• Title/Summary/Keyword: Clinical Trial Protocol

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A Review on Clinical Research Trends in the Treatment of Hatha-Style Yoga for Post Traumatic Stress Disorder (외상후 스트레스장애에 대한 하타 스타일 요가 치료의 해외 임상연구 동향)

  • Hong, Hee-Yeon;Hong, Min-Ho;Koo, Byung-Su;Kim, Geun-Woo
    • Journal of Oriental Neuropsychiatry
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    • v.31 no.1
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    • pp.13-23
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    • 2020
  • Objectives: The purpose of this study was to review the research trends in the treatment of hatha-style yoga on Post Traumatic Stress Disorder (PTSD). Methods: We searched articles in Pubmed and the China National Knowledge Infrastructure (CNKI) January 2010-December 2019, for studies to treat PTSD using hatha-style yoga. Selected studies were evaluated by the CLEAR-NPT (A Checklist to Evaluate a Report of a Non-pharmacological Trial). Results: Seven randomized controlled clinical trials were selected. PSS-I (PTSD Symptom Scale-Interview) was the most frequently used as diagnostic criteria. The PCL (PTSD Checklist) was also the most commonly used outcome measurement. Of the seven articles, most studies reported that hatha-style yoga was effective to reduce symptoms of PTSD. Conclusions: Hatha-style yoga practice intervention can be used to relieve symptoms of PTSD. More studies should be conducted to make hatha-style yoga as protocol (complementary therapy) for PTSD patients.

Development of Web-based Nursing Education Program for Ostomy Care (장루 관리를 위한 Web 기반 간호교육 프로그램 개발)

  • Hong, Hae-Sook
    • Journal of Home Health Care Nursing
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    • v.10 no.2
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    • pp.141-147
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    • 2003
  • The purpose of this study was to develop and apply a Web-based Nursing Education & Instruction Program to help the clinical nurses improving their knowledge and skills of ostomy care. This program was developed in three different steps: analysis. design. and development. The results of the study were as follows: The analysis step was designed to select the study contents for effective and easy educationthrough the analyses of specialized books. This surveyed and analyzed study contents were categorized into five different sections. Introduction. ostomy classification. ostomy management. elimination management. and life style. After that each section describes necessary information of each category. In the design step. the image files used in this program were created using Adobe Photoshop 6.0. and HTML files were designed and developed using Namo Editor 5.0. In the development step. the developed program was published into Web using FTP (File Transfer Protocol) and then finalized after trial operation for testing of real users. In addition. this Web-based Nursing Education & Instruction Program will be used as excellentand effective tool for continuous and lifelong education in nursingfield. In this study. computer-aided education program was developed for ostomy management and managed at the Web-Server (http://hshong.knu.ac.kr/ostomy) in order to help nurses real-time education in clinical field by this program.

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The Effect of PROM and AAROM Exercise After TKA on Increasing the Knee Range of Motion (슬관절 전치환술 후 수동 및 능동 보조 관절가동범위운동이 슬관절 가동범위 증가에 미치는 영향)

  • Kim, In-Bok;Kim, Yoon-Seong
    • Journal of Korean Physical Therapy Science
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    • v.16 no.4
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    • pp.11-17
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    • 2009
  • Background: The purpose of this study was to find out the real truth of the effect of PROM (Passive range of motion) and AAROM (Active assistive range of motion) exercise on increasing the knee flexion. This randomized, controlled trial examined whether or not the incorporation of PROME(passive range of motion exercise) to a postoperative rehabilitation protocol would offer a better clinical outcome after TKA (Total knee arthroplasty) Method: The subject (n=36) measured range of motion (ROM).18 consecutive patients who underwent TKAs at SNUH dept. OS received PROME for knee by a physical therapist during the physiotherapy sessions and not for the other 18 patients who underwent TKAs received No-PROME (AAROME) for knee by herself. Result: There were significant differences in the PROME group, No-PROME group ROM progress width And there were significant differences in the PROME group between No-PROME group ROM improvement width. Conclusion: This study demonstrates that the incorporation of PROME does offer additional clinical benefits to the patients after TKA. Our findings may suggest that encouraging patients to perform PROM exercises would be a better option and that physiotherapy session by a physical therapist holds good even now.

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E-mail Survey for Developing Clinical Guideline Protocol on Acupuncture Treatment for Low Back Pain (요통에 관한 침구임상 진료지침 프로토콜 개발을 위한 전자우편 설문조사)

  • Lee, Seung-Hoon;Nam, Dong-Woo;Kang, Jung-Won;Kim, Eun-Jung;Kim, Hyun-Wook;Song, Ho-Sueb;Kim, Sun-Woong;Kim, Kap-Sung;Lee, Geon-Mok;Lee, Jae-Dong
    • Journal of Acupuncture Research
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    • v.26 no.3
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    • pp.115-131
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    • 2009
  • Objectives: This survey was done in order to find out how Korean medical doctors derive pattern identification for acupuncture prescriptions in treating low back pain in real clinical practice. Methods : The survey questionnaire was developed by the committee of experts who major in acupuncture & moxibustion or statistics for acupuncture clinical trial protocol development. The questionnaires were distributed via e-mail to 75 members of Korean Acupuncture & moxibustion society from March 26th to April 14th in 2009. 57 members completed answers, and the computerized data were analyzed by SPSS 17.0 statistical program. Results : 1.57 Korean medical doctors selected meridian pattern identification based on the course of the meridians(44.6%), visceral pattern identification(32.1%), pattern identification based on cause of disease(14.3%) as the most commonly used pattern identification methods for acupuncture prescription when treating low back pain patients in real clinical practice. 2. In meridian pattern identification based on the course of the meridians, gallbladder meridian of hypochondriac region(13.0%), bladder meridian of lateral low back region(11.2%), governer vessel of central low back region(11.7%) were selected 3. In visceral pattern identification, yang deficiency of kidney(20.2%), deficiency of kidney(19.3%), liver(16.7%), yin deficiency of kidney(14.0%), violence qi of kidney(8.8%), small intestine(7.9%) were selected. Conclusions : In our e-mail survey, Korean medical doctors answered that Meridian Pattern Identification based on the course of the meridians is the most often used diagnosis method. Visceral pattern identification, pattern identification based on cause of disease, meridian pattern identification based on symptom and pattern identification based on qi-blood-yin-yang theory in order of frequency used, were selected for low back pain diagnosis in real clinical practice.

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Yukgunja-tang for Irritable Bowel Syndrome: A Protocol for a Systematic Review and Meta-Analysis

  • Kangwook Lee;Seok-Jae Ko;Minjeong Kim;Chaehyun Park;Min-Seok Cho;Jae-Woo Park
    • The Journal of Internal Korean Medicine
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    • v.44 no.3
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    • pp.285-293
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    • 2023
  • Background: Irritable bowel syndrome (IBS) is a digestive disorder characterized by abdominal discomfort or pain accompanied by a change in stool condition. Owing to its complicated mechanisms, a standard treatment for IBS has not yet been established. Yukgunja-tang (YGT) is a Korean herbal medicine known in Asia to be effective in the treatment of gastrointestinal symptoms. In this study, we will conduct a systematic review of randomized controlled trials (RCTs) to assess the efficacy and safety of YGT in IBS treatment. Methods and analysis: English databases, such as Embase, Medline (via PubMed), Allied and Complementary Medicine Database, and Cochrane Central Register of Controlled Trials, will be searched for articles published up to April 2023. Additional databases, such as five Korean, one Chinese, and one Japanese database, will be included. RCTs and quasi-RCTs will also be included in the assessment of the efficacy of YGT. The overall efficacy rate will be the primary outcome, and data such as IBS quality-of-life measurements, global symptom scores, and adverse events will be the secondary outcomes. Review Manager Version 5.3 will be used for evaluation, and the risk of bias (RoB) will be evaluated using Cochrane Collaboration's RoB tool. The Grading of Recommendations Assessment, Development, and Evaluation approach will be used to score the quality of evidence. Conclusion: This study will demonstrate the efficacy and safety of YGT for treating patients with IBS.

The Effect of Glasthma Syrup in Asthma: a study protocol for a triple-blind randomized controlled trial

  • Derakhshan, Ali Reza;Saeidinejat, Shahin;Khadem-Rezaiyan, Majid;Asnaashari, Amir-Mohammad-Hashem;Mirsadraee, Majid;Salari, Roshanak;Jabbari-Azad, Farahzad;Jalali, Shima;Jalali, Shabnam
    • Journal of Pharmacopuncture
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    • v.25 no.3
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    • pp.233-241
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    • 2022
  • Objectives: Asthma is a chronic disease, and the demand for herbal medicines in this field has increased in recent years. The new findings highlight the role of the gut-lung axis in the pathophysiology of asthma. Hence, this study will evaluate the safety and efficacy of Glasthma syrup, an herbal formula based on Persian medicine, in improving asthma and regulating intestinal permeability. The formula consists of five herbal ingredients that have anti-inflammatory effects on the respiratory tract, also known as gut tonics. Methods: The study will be conducted as a placebo-controlled, triple-blind, randomized trial. It will consist of a 4-week intervention followed by a 4-week follow-up period. The target sample size is 20 patients with moderate asthma aged 18 to 60 years. Eligible participants will be randomly assigned to either the experimental group or the control group in equal numbers. Patients in the experimental group will take Glasthma syrup (7.5 mL, twice a day), while patients in the control group will take a matching placebo. Both groups will receive a 4-week combination of a long-acting beta2 agonist and a leukotriene modulator as standard of care. Inhaled corticosteroids can be used as rescue medication as needed. Results: The primary outcomes are asthma symptom scale, lung function, and intestinal permeability. Secondary outcomes include quality of life, symptom recurrence rates, and blood tests. A safety assessment will also be conducted during the trial. Conclusion: In this trial, the effects of Glasthma syrup in patients with moderate asthma will be examined. The study will also assess the effects of the formulation on the gut-lung axis by simultaneously monitoring the gut permeability index, asthma symptoms, and lung function.

Results of Transfer of Cryopreserved Supernumerary Embryos Obtained after Conventional in vitro Fertilization and Intracytoplasmic Sperm Injection (ICSI) (일반적인 체외수정 방법과 세포질내 정자주입술로 얻어진 배아의 동결-융해 후 이식의 결과)

  • Kim, Jeong-Wook;Han, Mi-Hyun;Byun, Hye-Kyung;Jun, Jin-Hyun;Son, Il-Pyo;Koong, Mi-Kyoung;Paik, Eun-Chan;Kang, Inn-Soo;Lee, Ho-Joon
    • Clinical and Experimental Reproductive Medicine
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    • v.24 no.1
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    • pp.111-118
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    • 1997
  • Intracytoplasmic sperm injection (ICSI) recently has been utilized widely as the most successful technique to overcome the unfertilization problem in cases of severe male infertility in couples who could not be treated by conventional IVF. Recently, indications of ICSI have been extended further and more fertilized oocytes become available. Thus, it is necessary to examine the efficiency of freezing the surplus embryos obtained from ICSI. We compared the survival rate and the future outcome of cryopreserved embryos obtained either after conventional IVF or ICSI during the same period. After ICSI or IVF, five best-quality embryos from each patient were transferred in the stimulation cycle and the surplus pronuclear (PN) stage oocytes or multicellular embryos were cryopreserved by slow freezing protocol with 1,2-propanediol (PROH) as a cryoprotectant. A total of 792 embryos from ICSI trial were thawed and 65.2% (516/792) survived. The survival rates of PN stage oocyte, multicellular embryo and PN + multicellular embryo were 63.5%, 68.2%, 64.0%, respectively. After 111 transfers, 34 pregnancies were achieved, corresponding to a clinical pregnancy rate of 30.6% per transfers. We thawed 1033 embryos from IVF trials and 57.5% (594/1033) survived. In IVF cycle, the survival rates of PN stage oocyte, multicellular embryo and PN + multicellular embryo were 58.2%, 65.2%, 40.2%, respectively. Thirty eight clinical pregnancies were established after 134 transfers, corresponding to a pregnancy rate of 28.4% per transfer. The cleavage rate of thawed PN stage oocytes from ICSI trial (61.3%) was significantly higher than those from conventional IVF (53.4%). The developmental rates of good embryo (${\geqq}$ grade II) in thawed PN stage oocytes obtained from conventional IVF and ICSI were 63% and 65%, respectively. We concluded that PN stage oocytes, multicellular embryos resulting from ICSI procedure can be successfully frozen/thawed with reasonable clinical pregnancy rates comparable to those of IVF.

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Administration of Yijung-tang, Pyeongwi-san, and Shihosogan-tang for Standardization of Korean Medicine Pattern Identification for Functional Dyspepsia: A Study Protocol of a Randomized, Assessor-blind, 3-Arm, Parallel, Open-label, Multicenter Clinical Trial (기능성 소화불량 한의 변증 표준화를 위한 이중탕, 평위산 및 시호소간탕 투여 : 무작위 배정, 평가자 눈가림, 3군 비교, 평행 설계, 공개, 다기관 임상시험 프로토콜)

  • Boram Lee;Min-Jin Cho;Young-Eun Choi;Ojin Kwon;Mi Young Lim;Seok-Jae Ko;So-yeon Kim;Yongjoo Kim;Donghyun Nam;Dong-Jun Choi;Jun-Hwan Lee;Jae-Woo Park;Hojun Kim
    • The Journal of Internal Korean Medicine
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    • v.43 no.6
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    • pp.1105-1121
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    • 2022
  • Objectives: The purpose of this study is to explore the effectiveness and safety of frequently used clinical herbal medicines (Yijung-tang [Lizhong-tang, LJT], Pyeongwi-san [Pingwei-san, PWS], and Shihosogan-tang [Chaihu Shugan-tang, SST]) in patients with functional dyspepsia (FD) when administered according to herbal medicine and Korean medicine pattern identification. The results of this study will be used to standardize the diagnostic instrument used in Korean medicine and to investigate biomarkers of Korean medicine pattern identification. Methods: This study will be a randomized, assessor-blind, 3-arm, parallel, open-label, multi-center clinical trial. A total of 300 FD participants will be recruited from 3 Korean medical hospitals and assigned to the LJT (n=100), PWS (n=100), and SST (n=100) groups according to FD pattern identification. The patients will take the medication for 8 weeks, 3 times a day, before or between meals. The primary outcome will be total dyspepsia symptom (TDS) and the secondary outcomes will be adequate relief (AR) for dyspepsia, overall treatment effect (OTE), visual analogue scale (VAS), functional dyspepsia-related quality of life (FD-QoL), gastrointestinal symptom score (GIS), and pattern identification questionnaires. For the exploratory outcomes, we will analyze blood and fecal metabolome profiles, microbiota from fecal and saliva samples, single nucleotide polymorphism (SNP), and results of Korean medicine diagnosis device measurements (heart rate variability, and tongue, pulse, and abdominal diagnosis). Conclusions: The results of this study will prove objectivity for Korean medicine pattern identifications, and the effectiveness and safety of herbal medicines for the population with FD.

Clinical Efficacy and Safety of Gyebutang Granules Combined with Acupuncture for the Treatment of Knee Osteoarthritis: Protocol for a Multicenter, Randomized, Assessor-blinded, 2-armed Parallel, Controlled Trial

  • Lee, Cham-Kyul;Kang, Ha-Ra;Lee, Yeon-Sun;Sung, Won-Suk;Lim, Chi-Yeon;Jung, Chan-Yung;Kim, Eun-Jung;Seo, Byung-Kwan;Baek, Yong-Hyeon;Kim, Kyung-Ho;Lee, Eun-Young
    • Journal of Acupuncture Research
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    • v.37 no.2
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    • pp.102-109
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    • 2020
  • Background: Due to the aging population in Korea, knee osteoarthritis (KOA) has become an increasingly common condition. Many patients with KOA prefer analgesics, herbal medicines, acupuncture, or exercise, rather than arthroscopic surgery or a knee replacement. Gyebutang (GB) granules are a herbal extract widely used to treat KOA in traditional Korean medicine, but there is insufficient evidence of its efficacy and safety. Methods: A multicenter, randomized, assessor-blinded, 2-armed parallel, controlled clinical trial has been designed to investigate the efficacy and safety of GB combined with acupuncture for the treatment of KOA. There will be 100 patients with KOA enrolled in the study from 3 traditional Korean medicine hospitals. The participants will be randomly allocated to an experimental group (GB and acupuncture) or a control group (celecoxib and acupuncture) in a 1:1 ratio. Both groups will receive acupuncture treatment once a week for 6 weeks; one group will receive GB and the other will receive celecoxib for the same duration. Results: The primary outcome will be the change of knee osteoarthritic pain, based on scores on a 100 mm visual analog scale. The secondary outcomes will be scores on a numeric rating scale, the Western Ontario and McMaster Universities osteoarthritis index, patient global assessment, European quality of life 5-dimension 5-level scale, and adverse events. Conclusion: The results of this study will provide evidence of efficacy and safety of GB as a treatment for patients with KOA.

Regulations and Guidelines for Planning and Design of Multi-regional Clinical Trials (다지역 임상시험의 계획 및 설계에 대한 국제 제도적 동향 분석)

  • Song, Yun-Kyoung;Sohn, Minji;Jeon, Ah Young;Kim, Jae Hyun;Ji, Eunhee;Oh, Jung Mi;Kim, In-Wha
    • Korean Journal of Clinical Pharmacy
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    • v.28 no.2
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    • pp.146-153
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    • 2018
  • Objective: Multi-regional clinical trials have been widely used for accelerating global drug development by multinational pharmaceutical companies. In this study, we aimed to review and analyze the international trends in regulations and guidelines on multi-regional clinical trials by regulatory authorities and international organizations, such as International Conference on Harmonisation, for referring to policies, including development of domestic guidelines for multi-regional clinical trials. Methods: The policies, regulations, and guidelines published by the US Food and Drug Administration, European Medicines Agency, Pharmaceuticals and Medical Devices Agency (Japan), and China Food and Drug Administration were searched, and the International Conference on Harmonisation E17 draft guideline was reviewed. Results: The regulatory authorities in developed countries have developed and implemented regulations and guidelines on multi-regional clinical trials to promote simultaneous global drug development and evaluate the regional differences in drug safety and efficacy. International Conference on Harmonisation developed the draft guideline for planning/designing of multi-regional clinical trials in 2016, which recommends the general principles for strategy-related issues and design of multi-regional clinical trials, and for protocol-related issues, such as consideration of regional variability, subject selection, dose selection, endpoints, comparators, overall sample size, allocation to regions, collecting information on efficacy and safety, and statistical analysis. Conclusion: It is important to understand the international regulatory requirements for designing and planning of multi-regional clinical trials for global drug development. Moreover, it is necessary to prepare multi-regional clinical trial guidelines in accordance with the Korean regulation for clinical trials and drug administration.