• 한방비만학회지
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• 제20권2호
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• pp.138-148
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• 2020

Objectives: The aim of this study is to evaluate the effects of Bangpungtongseong-san (Fangfengtongsheng-san, BTS) and Daesiho-tang (Dachaihu-tang, DST) on weight loss and improvement in lipid metabolism and glucose metabolism. Furthermore, we intend to develop a prediction model for drug effects through the analysis of the single nucleotide polymorphism (SNP), gut-microbiota, and the expression of immune-related biomarkers. Methods: This study is a single-center, randomized, double-blind, parallel-design clinical trial. One hundred twenty-eight participants will be assigned to the BTS group (n=64) and DST group (n=64). Both groups will be administered 4 g medication three times a day for up to 2 weeks. The primary outcomes is weight loss. The secondary outcomes include bioelectrical impedance analysis, waist circumstance, body mass index, total cholesterol, high-density lipoprotein, triglyceride, insulin resistance. The exploratory outcomes include 3-day dietary recall, food frequency questionnaire, quality of life questionnaire, gut microbiota analysis, immune biomarkers analysis, and SNP analysis. Assessment will be made at baseline and at week 4, 8, and 12. Conclusions: This protocol will be implemented by approval of the Institutional Review Board of Dongguk University. The results of this trial will provide a systematic evidence for the treatment of obesity and enable more precise herbal medicine prescriptions.

• Journal of Acupuncture Research
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• 제39권3호
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• pp.202-212
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• 2022

Background: The aim of this study was to evaluate the effectiveness and safety of Cheong-A-Won Gagambang (JCE003) treatment for degenerative knee osteoarthritis. Methods: This was a single-center, randomized, double-blind, placebo-controlled pilot clinical trial. There were 36 adults with degenerative knee osteoarthritis who were randomly allocated into JCE003 1,000 mg, JCE003 2,000 mg, or the placebo group (in a 1:1:1 ratio). The participants received 12 weeks of treatment and had scheduled tests every 6 weeks. The primary outcomes were measured using the Korean Western Ontario and McMaster Universities scale, and the secondary outcomes were measured using the visual analog scale, European quality of life-5-dimensions, patient global impression of change, C-reactive protein, and erythrocyte sedimentation rate. Changes between baseline scores and scores following study completion were analyzed. Results: There were 29 participants whose data were analyzed in this study. The change of Korean Western Ontario and McMaster Universities, visual analog scale, European quality of life-5-dimensions scores showed significant improvement in the JCE003 1,000 mg group. The change of patient global impression of change was significantly improved in the placebo group. There were 14 adverse events, but there was no clinically significant relationship with the intake of JCE003 compared with the placebo. Conclusion: Taking JCE003 may be effective at improving knee pain in patients with degenerative knee osteoarthritis and appears to be safe. Based on this study, the concentration and feasibility of the test group may be used when conducting a large-scale clinical trial of degenerative knee osteoarthritis in the future.

• 대한한의학회지
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• 제28권4호
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• pp.86-94
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• 2007

Objective : Kuesu point is a newly discovered point, it is located in 3-cun from the centre of sacrum laterally, paralleled to the 4th foramen on the sacrum. This controlled trial was to evaluate the superior effect of Kuesu point on back pain which radiated to lower extremities. Methods : Randomized Controlled Trial (RCT) and Single Blind in patient was designed. Patients (n=31) were randomized to two groups, Kuesu-point acupuncture group (Group A, n=16) and non Kuesu point acupuncture group (Group B, n=15). Group A was acupunctured on B25 (大腸兪), B26 (關元兪) and B60 (崑崙) with Kuesu point. Group B was acupunctured on the same points without Kuesu point. The clinical subjects were female patients. Beside acupuncture, the other therapies were excluded. Clinical period was three weeks total. Each group was treated 4-5 times per week for 3 weeks. The outcome measurements were The Estimation Index of Backache (quality of life), Pain Rating Scale (pain intensity) and other physical examinations (ROM, SLR, etc.). Results : 31 patients (Group A: n=16, Group B: n=15) were Randomized, 6 of them dropped out. Eventually 25 patients (Group A: n=15, Group B: n=10) were included in the analysis. Group A acupunctured on Kuesu point scored more significant Estimation Index of Backache and lower PRS (Pain Rating Scale) than Group B acupunctured without Kuesu point (p=0.003/2). It turned out that the group acupunctured on Kuesu point show meaningful high improvement index. And other examination's results showed that the treatment effects of Group A are twice as better as Group B. Conclusion : These results suggest that Kuesu point acupuncture was more effective on lower back pain and improved the life quality of patients, being compared with non Kuesu point acupuncture.

• Journal of Ginseng Research
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• 제46권1호
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• pp.71-78
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• 2022

Ginseng is an international herb that has been used for thousands of years. Two species most commonly applied and investigated in the ginseng family are Asian ginseng and American ginseng. The number of randomized controlled clinical trials (RCTs) has conspicuously increased, driven by the rapid development of ginseng. However, the reporting of RCT items of ginseng is deficient because of different trial designs and reporting formats, which is a challenge for researchers who are looking for the data with high quality and reliability. Thus, this study focused on providing an extensive analysis of these two species and examined the quality of the RCTs, based on the Consolidated Standards of Reporting Trials (CONSORT) guideline. Ninety-one RCTs conducted from 1980 to 2019 that were related to Asian ginseng and American ginseng used singly met our inclusion criteria. We found that the reporting quality of the two species has improved during the past 40 years. Publication date and sample size were significantly associated with the reporting quality. Rigorous RCTs designed for the species of ginseng are warranted, which can shed light on product research and development of ginseng in the future.

• 대한한방내과학회지
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• 제45권1호
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• pp.1-10
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• 2024

Objectives: This study investigated the pattern identification (PI) and clinical index of Parkinson's disease (PD) for personalized diagnosis and treatment. Methods: This prospective observational multi-center study recruited 100 patients diagnosed with PD from two Korean medicine hospitals. To cluster new subtypes of PD, items on a PI questionnaire (heat and cold, deficiency and excess, visceral PI) were evaluated along with pulse and tongue analysis. Gait analysis was performed and blood and feces molecular signature changes were assessed to explore biomarkers for new subtypes. In addition, unified PD rating scale II and III scores and the European quality of life 5-dimension questionnaire were assessed. Results: The clinical index obtained in this study analyzed the frequency statistics and hierarchical clustering analysis to classify new subtypes based on PI. Moreover, the biomarkers and current status of herbal medicine treatment were analyzed using the new subtypes. The results provide comprehensive data to investigate new subtypes and subtype-based biomarkers for the personalized diagnosis and treatment of PD patients. Ethical approval was obtained from the medical ethics committees of the two Korean medicine hospitals. All amendments to the research protocol were submitted and approved. Conclusions: An objective and standardized diagnostic tool is needed for the personalized treatment of PD by traditional Korean medicine. Therefore, we developed a clinical index as the basis for the PI clinical evaluation of PD. Trial Registration: This trial is registered with the Clinical Research Information Service (CRIS) (KCT0008677)

• 동의신경정신과학회지
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• 제35권1호
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• pp.15-26
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• 2024

Objectives: The objective of this study is to develop a specialized clinical research protocol for acupuncture treatment specifically designed for disaster survivors based on insights from an expert survey. Methods: An expert panel comprising specialists in neuropsychiatry, acupuncture, and clinical research methodology was assembled. Initial data to inform the clinical research protocol design was collected utilizing open-ended responses, multiple-choice questions, and a 5-point Likert scale to gauge agreement levels. Next, this data was disseminated to a panel of experts. A cohesive clinical research protocol was then formulated during a core panel meeting by integrating insights from a panel of 10 experts. Results: The protocol developed herein entails a non-randomized controlled study involving participants aged 19~64 years old who have been identified as high-risk or cautious according to the National Trauma Center screening test. The study design includes the establishment of an active control group, which allows for the assessment of an additional effect through comparison with conventional therapy. The selected acupuncture approach involves a combination of manual acupuncture and ear acupuncture. For clinical outcome assessment, the Clinician-Administered Posttraumatic Stress Disorder Scale for DSM-5 was proposed to gauge trauma symptoms. Representative scales for various domains such as depression, anxiety, anger, insomnia, pain, and quality of life were also provided for reference. Conclusions: The developed protocol is anticipated to streamline the swift design and initiation of clinical trials during disaster scenarios. It is also designed to be scalable, thereby enabling its application in both non-randomized control group studies and single-group before-and-after comparisons.

• 동의신경정신과학회지
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• 제24권3호
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• pp.201-210
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• 2013

Objectives : To review the recent trend of randomized controlled clinical trials on insomnia and to provide information for future clinical trials. Methods : A total of 667 pieces of literature were searched using the key words 'insomnia' and 'randomized controlled trial' and using the title 'insomnia' with the topic 'trial or trials', published from 2008 to 2012 through Web of Science. Studies including randomized controlled clinical trials were sorted from the search result and finally 104 pieces of the literature were selected and examined. Results : Besides 104 clinical trials, 14 trials related to CAM (Complementary and Alternative Medicine) were also reviewed. On average, 20 trials were annually conducted and they showed a growing trend. Participants were between 31 and 90 (34.6%), and were observed for less than 30 days (28.8%) in most trials. As intervention methods for clinical trials, non-pharmaceutical methods were used in 59 studies (56.7%), pharmaceutical drug in 43 studies (41.3%) and combinations in 2 studies (1.9%). In 60 studies, only insomnia without any underlying diseases was examined and other 44 studies involved other diseases. As diagnosis assessment tools, Sleep diary and Polysomnography were used. Conclusions : Randomized controlled trials relevant to insomnia were on the increase, but only a small number of clinical trials on Oriental Medicine have been performed. Larger scientific and well-founded randomized controlled trials are required for developing Oriental Medicine and establishing high-quality guideline going forward.

• 대한한의학방제학회지
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• 제32권3호
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• pp.325-343
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• 2024

Objective : To understand how Chungsangboha-tang (CSBHT) is being utilized in clinical practice and research in Korea, clinical studies related to CSBHT published in domestic academic journals were analyzed. Methods : The search was conducted using the following six databases: Korean Traditional Knowledge Portal, Oriental Medicine Advanced Searching Integrated System, ScienceON, Research Information Sharing Service, Koreanstudies Information Service System, and The Journal of Internal Korean Medicine. After selecting relevant literature published before June 24, 2024, the studies were classified and analyzed according to their research design. Results : The final selection comprised 20 studies categorized as follows: 1 non-randomized controlled trial and 10 before-and-after studies in prospective clinical research, along with 7 case reports and 2 retrospective chart reviews in retrospective clinical studies. Among the 233 participants included in these studies, 169 had asthma, 53 had chronic cough, and 5 had chronic obstructive pulmonary disease. Additionally, other conditions reported included Churg-Strauss syndrome, pulmonary Langerhans cell histiocytosis, non-tuberculous mycobacterial pulmonary disease, bronchiectasis, and pulmonary hypertension. CSBHT was administered as a decoction in 13 studies, as granules in 6 studies, and both in one study. The most frequently used assessment tools were pulmonary function tests and quality of life evaluations. For safety assessment, liver function test results and adverse events were reported. Conclusion : To enhance the utilization of CSBHT in Korean medicine clinical practice, continuous accumulation of domestic clinical research is essential. Moreover, meticulously designed randomized controlled trials are necessary to elevate the level of evidence.

• 인터넷정보학회논문지
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• 제13권1호
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• pp.45-55
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• 2012

임상시험 전체 소요시간 및 비용의 절감, 임상 데이터 질의 향상을 위해 임상시험 전자자료의 관리가 점차 중요해지고 있다. 또한 임상시험 전자자료 관리는 전자 임상시험의 안정성 및 질을 위해 규정 가이드라인을 준수하는 것이 결정적으로 필요하다. 본 연구는 전자적 시스템을 활용한 임상시험에 있어 데이터 관리의 성과를 평가하기 위한 프레임웍을 개발하고자 한다. 연구의 목적을 위해 임상시험 프로세스에 근거하여 기반능력, 연구설계, 연구진행 및 연구완료 등 네 개의 주요 메트릭을 구성함으로써 데이터 관리의 수준을 측정할 수 있는 성과척도를 도출한다. 이때 각 성과척도의 도출 기준은 임상시험 자체가 지향하는 데이터의 질 향상, 전자자료 관리 프로세스의 비용과 효율성 및 규정 준수 수준 등 네 가지의 관리적 관심을 기준으로 하며, 각 성과척도 별로 전자자료 관리 프로세스 상 실질적으로 측정 가능한 측정지표를 제시한다. 평가 프레임웍은 네 가지의 주요 측정 메트릭에 근거하여, 세 개의 데이터 영역(연구기관, 모니터링, 데이터관리센터) 별로 구성된다. 본 평가 프레임웍의 개발은 전문가 의견 수렴을 통한 델파이 방법론으로 접근한 탐색적 연구로서 향후 실증적 후속 연구를 과제로 남기고 있다.

• 대한한의학회지
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• 제30권5호
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• pp.115-126
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• 2009

Objective: By assessing the quality of methodology and synthesis of results of RCTs (Randomized Controlled Clinical Trials) with herbal acupuncture (pharmacopuncture), we hope to help with administrating herbal acupuncture therapy in clinic and conducting RCT with herbal acupuncture. Methods: Reports of RCT conducted in Korea published in medical journals until February 2009 were collected. We surveyed elementary information of RCTs, evaluated randomization, double-blinding, allocation concealment and put together the results of RCTs by seven clinical topics. Results: 38 RCTs with herbal acupuncture were selected, then adequate methods for randomization and allocation concealment were found in 39% and 5% of studies. Complete double-blinding and a clear accounting of all participants were conducted in 42% and 50% of reports. The synthesis of RCTs revealed that herbal acupuncture was useful and effective on degenerative gonarthritis, omarthralgia on cerebrovascular accident, acute ankle sprain, back sprain, neck sprain, headache, rheumatoid arthritis and tennis elbow, generally. Conclusions: Although further improvement in quality of methodology of RCTs with herbal acupuncture is required, clinical usefulness of herbal acupuncture was shown especially on disorders of musculoskeletal system via RCTs.