• Title/Summary/Keyword: Randomized Clinical Trials

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Study of Efficacy and Safety of Ginseng Seed Oil in Heathy Subjects Who Have Mild Liver Dysfunction : A Randomized, Double Blinded, Placebo-Controlled Study (경증의 간 기능 이상 소견을 보이는 건강한 성인에 대한 인삼종자오일의 유효성 및 안전성 연구 : 무작위배정, 이중눈가림, 위약대조 연구)

  • Kim, Young-Ji;Kwon, Jung-Yeon;Go, Ho-Yeon;Lee, Dong-Nyung;Ko, Sung-Kwon;Kong, Kyung-Hwan
    • The Journal of Korean Medicine
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    • v.39 no.2
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    • pp.36-55
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    • 2018
  • Objectives: The purpose of this study was to investigate the effectiveness and safety of ginseng seed oil in healthy subjects who have mild liver dysfunction. Methods: A randomized, double blinded, placebo-controlled trial was conducted. A total of 167 subjects visited Semyung University Hospital from July 1st, 2016 to June 10th 2017. Except for the 103 excluded subjects, 64 subjects were randomized into one of the two groups: an treatment group(n=33) and control group(n=31). Subjects were randomly given either ginseng oil seed capsules or indistinguishable placebo capsules(2 capsules per dose, twice per day). Laboratory tests(aspartate aminotransferase, alanine aminotransferase, gamma glutamyl transpeptidase, triglyceride, total cholesterol, high density lipoprotein-cholesterol, low density lipoprotein-cholesterol) were performed to evaluate the effectiveness after 6, 12 weeks of treatment. Vital sign, laboratory test were performed to assess safety at every visit. Results: There were no significant differences in efficacy between treatment group and control group. There were some adverse events with no significant difference in symptoms and frequency between treatment group and control group. Conclusions: Although the efficacy of ginseng seed oil was not proved, ginseng seed oil did not worsen liver function and proved its safety. More study of ginseng seed oil and clinical trials are necessary to increase the usefulness of above-ground parts of ginseng.

A Literature Study of Topical Application of Chinese Herbal Medicine for Allergic Rhinitis (국소한약외용제의 알레르기성 비염 치료 효과에 대한 문헌 고찰)

  • Bang, Mi Ran;Kim, Jang Hyun;Min, Sang Yeon
    • The Journal of Pediatrics of Korean Medicine
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    • v.30 no.3
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    • pp.52-60
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    • 2016
  • Objectives The purpose of this study is to analyze studies about the effects of topical application of Chinese herbal medicine for allergic rhinitis within randomized controlled trials (RCT). Methods The search database includes KJTK (Korean Traditional Knowledge Portal), OASIS (Oriental Medicine Advanced Searching Integrated system), CNKI (China National Knowledge Infrastructure), PubMed, and EMBASE. We used the following key search terms: "allergic rhinitis", "traditional Chinese medicine", "traditional Korean medicine", "Chinese herbal medicine", "randomized controlled trial", "clinical study", "nasal spray", and "nasal drop" Results Five studies were selected for analysis. Three studies used nasal spray of Chinese herbal medicine and two studies used nasal drops of Chinese herbal medicine for the intervention. Frequently used herbs were Magnoliae Flos (辛夷), Scutellariae Radix (黃芩), Coptidis Rhizoma (黃連), and Astragali Radix (黃芪). For the outcome measures, studies used symptom score, questionnaire of Quality of Life, nasal airway resistance, or laboratory studies. From all 5 studies, it has been shown that topical application of Chinese herbal medicine was effective for improving symptoms of allergic rhinitis. Two out of five studies showed statistical difference between study group and control group. Conclusions This study shows that topical application of Chinese herbal medicine can improve symptoms of allergic rhinitis. Well-designed RCT studies with low risk of bias and studies with outcome measures for assessing the immunomodulatory effects are necessary to confirm these findings.

Acupotomy for Carpal Tunnel Syndrome: A Systematic Review and Meta-Analysis (수근관증후군에 대한 도침치료의 효과: 체계적 문헌 고찰과 메타분석)

  • Jeong, Jae-Min;Sul, Jae-Uk;Kim, Seon-Jong;Seon, Yun-Gwon;Choi, Ji-Min;Noh, Hui-Jeong;Choi, Jin-Bong
    • Journal of Korean Medicine Rehabilitation
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    • v.32 no.3
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    • pp.55-64
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    • 2022
  • Objectives The objective of this study was to assess the effectiveness of acupotomy for carpal tunnel syndrome. Methods Based on seven domestic and foreign databases. We analyzed the randomized controlled trials using acupotomy for carpal tunnel syndrome. The treatment group was treated with acupotomy and the control group was no restrictions on treatment methods. Results In this study, the effect of acupuncture treatment for carpal tunnel syndrome was investigated. Each study reported that acupotomy could be an effective treatment for carpal tunnel syndrome. However, as a result of meta-analysis of Levine carpal tunnel syndrome questionnaire scores, visual analog scale, and sensory nerve conduction velocity, the results were more clinically significant than those of the control group. Due to the small number of randomized controlled trial studies and the nature of acupotomy treatment, blinding of interventions was impossible, resulting in a high risk of bias. Conclusions In this regard, it is thought that well-planned randomized controlled studies on patients with carpal tunnel syndrome are needed in the future to secure the clinical evidence for acupotomy treatment.

Narrative Review of Clinical Trial on Scolopendrid Pharmacopuncture in Korean Literature (국내 데이터 베이스 검색을 통한 오공 약침 시술에 대한 임상 논문고찰)

  • Jo, Dong-Chan;Lee, Jin-Hyun;Kim, Chang-Gon;Jung, Woo-Seok;Moon, Su-Jeong;Park, Tae-Yong;Lee, Jung-Han
    • Journal of Korean Medicine Rehabilitation
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    • v.23 no.4
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    • pp.73-82
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    • 2013
  • Objectives The purpose of this review is to investigate studies of Scolopendrid pharmacopuncture and the evidence of it's effects in order to suggest a better research method in the future. Methods We retrieved numbers of clinical studies about Scolopendrid pharmacopuncture from 7 Korean web databases, using key words such as 'Scolopendrid', 'Scolopendrid AND Pharmacopuncture'. This study had been conducted from 1st May 2013 to 31th July 2013. Controlled studies and case studies were only used for this study. Clinical studies that we picked from the databases were classified according to the diseases that those studies are about, and from these clinical studies, we are to research what has to be improved generally in clinical researches. Results 18 case studies, 4 controlled studies had been under research. Scolopendrid pharmacopuncture has a therapeutic effect mainly in musculoskeletal and neurological diseases such as herniated intervertebral disc, carpal tunnel syndrome, swollen leg, feeling of cold on legs, wrist ganglion, lateral epicondylitis, radial nerve palsy, cervical myelopathy, cauda equina syndrome, postauricular pain; as an early symptom of Bell's palsy, pain of popliteal part, gout, plantar fasciitis, cellulitis, frozen shoulder, pain of hip adductors. However objectivity and reliability of the Scolopendrid pharmacopuncture studies still remains controversial. Conclusions It has been suggested that there are positive effects of Scolopendrid pharmacopuncture therapy in treating specific diseases (especially neuromusculoskeletal diseases). However, this narrative review can't conclude and prove that the Scolopendrid pharmacopuncture has positive effectiveness on these diseases unlike systematic review. So, in order to put Scolopendrid pharmacopuncture therapy to use for many kinds of diseases in more reasonable ways, it is essential to build well-designed clinical research tools. In the future, abundant case studies, more follow-up trials and randomized controlled trials based on the korean medicine should be done to use Scolopendrid pharmacopuncture for a clinical purpose.

A Research to Evaluate the Safety and Efficacy of Yukwool-tang (Liuyu-tang) for Major Depression in Women: A Study Protocol for a Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Clinical Trial (여성의 주요우울증에 대한 노에스액(육울탕)의 안전성, 유효성 평가 : 무작위배정, 양측눈가림, 위약대조, 평행설계 임상시험 프로토콜)

  • Seo, Young Kyung;Lee, Eun Hee;Kim, Hwan;Lee, Ji-yoon;Park, Chae Rin;Choi, Sunyoung;Jang, Eunsu;Kwon, Ojin;Kim, Hyungjun;Jung, In Chul
    • Journal of Oriental Neuropsychiatry
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    • v.29 no.1
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    • pp.35-46
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    • 2018
  • Objectives: The aim of this trial is to evaluate the efficacy and safety of Yukwool-tang (Liuyu-tang) for the treatment of major depression in women by comparing the Yukwool-tang (Liuyu-tang)-treated group with the placebo-treated group and assessing the association of various biological factors related to depression through various outcome measures. Methods: This study is a single-center, randomized, double-blind, placebo-controlled, parallel-design clinical trial. The subjects to be selected are women between the ages of 19 and 65, and the registered subjects are to be randomly assigned to treatment with Yukwool-tang or the placebo control. The Yukwool-tang group will take 1 bottle of Yukwool-tang (30 mg) for 8 weeks, 3 times a day, before meals. The control group will take the placebo in the same way. The primary outcome to be examined will be the change between the total score after 8 weeks and the total score before the start of the study of the K-HDRS score. Secondary outcomes are assessed by the change in total score after 12 weeks of K-HDRS, K-HDRS remission rate, K-HDRS improvement rate, BDI-K, PITD, KSCL-95, ISI, STAI-K, EQ-5D, VAS, Emotional Stimulation Test, BDNF test, inflammatory cytokine and tumor necrosis factor test, intestinal microbiome test, dietary report and Beck's hopelessness scale. Results: This protocol has been approved by the IRB of Dunsan Korean Medicine Hospital of Daejeon University and is registered in the CRIS, and it is made public in advance to ensure transparency of the research process and conduct ethical clinical trials. Conclusions: Based on this protocol, when the trial is completed, its data can be used to access the validity and safety of Yukwool-tang for major depression in women, and it is also expected to be helpful in the study of the correlation between future treatment of Korean medicine for depression and related biological factors, and quality of life.

Acupuncture for Lumbar Spinal Stenosis in Korean Literature: a Systematic Review (요추 척추관 협착증에 대한 침구치료의 국내 임상근거: 체계적 문헌고찰)

  • Kim, Kun-Hyung;Noh, Seung-Hee;Lee, Byung-Ryul;Kim, Jae-Kyu;Yang, Gi-Young
    • Journal of Acupuncture Research
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    • v.28 no.6
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    • pp.93-105
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    • 2011
  • Objectives : This study aims to evaluate currently available clinical evidence for the use of acupuncture in patients with lumbar spinal stenosis in the context of Republic of Korea. Methods : Five Korean databases were searched for all clinical studies employing acupuncture for patients with lumbar spinal stenosis. The exceptions were case reports and series involving less than 10 patients from their inception to September 2011. Only studies reported in Korean databases were searched. Results : Five retrospective audits among 22 initially identified studies were eligible for analysis in this review. There was no randomized controlled trial for this topic. The number of patients varied between 15 and 119 in each audit, and all the patients analyzed were inpatients. In all the included studies, acupuncture was conducted in combination with other concomitant treatments, including moxibustion, cupping, herbal remedies, acupoint injection, Chuna, and various physical therapies. All the included audits reported symptomatic and/or functional improvements compared to baseline. None of the included audits indicated whether any adverse events were reported. Conclusions : Current evidence for the use of acupuncture in patients with lumbar spinal stenosis in the context of South Korea is based solely on five retrospective audits that are very likely prone to a high risk of bias. Thus, further prospective and methodologically sound clinical trials to overcome this huge gap between clinical practice and the available evidence for the use of acupuncture in patients with lumbar spinal stenosis are needed.

Study for Clinicians' Perception on the Acupuncture Research and Ways to Symbiosis between Basic Research and Clinical Practice (침 연구에 대한 한의사의 인식과 연구방향에 대한 조사)

  • Kim, Song-Yi;Chae, Youn-Byoung;Lee, Hyang-Sook;Ko, Yu-Mi;Lee, Hye-Jung;Park, Hi-Joon
    • Korean Journal of Acupuncture
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    • v.29 no.2
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    • pp.224-238
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    • 2012
  • Objectives : From mechanism studies using animal models to high-level evidence based research such as randomized controlled trials or systematic reviews, various acupuncture studies have been performed. Nevertheless, the current research appears insufficient to satisfy clinicians' needs. We aimed at investigating clinicians' perception on the translational research and suggesting ways of symbiosis between basic research and clinical practice. Methods : Data were collected using a web-based questionnaire made available to Korean medicine doctors who were informed through social networking service or e-mail. The survey participants indicated their awareness of acupuncture research and their thoughts on the applicability of research in practice. Results : Forty-seven clinicians completed the survey. While most respondents agreed that acupuncture research is very important, only 40% of them answered that the results of acupuncture research are useful to their own practice. In more than half of those who responded to the survey, the current acupuncture research is not viewed as reflecting clinical practice very much. Respondents agreed that acupuncture research should be based on clinical practice, and they recognized the need to collect valid clinical data from real-world practice. Also, as many as 77% of clinicians had no scruple to participate in research programs. Conclusions : There is no doubt among practitioners that acupuncture research is necessary. More importantly, practice-based research remains essential in order to feed-back research outcomes to clinical practice. Communications and academic exchanges between clinicians and researchers can mutually benefit research and practice with better information, resulting in symbiosis.

Clinical Practice Guideline for acupuncture in Post-stroke urinary retention (뇌졸중후 요저류에 대한 침치료 임상진료지침)

  • Lee, Ji-Won;Lee, Eui-Ju;Shin, Byung-Cheul;Lee, Myeong-Soo;Lim, Sung-Min;Cho, Chung-Sik;Moon, Sang-Kwan
    • The Journal of Korean Medicine
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    • v.37 no.1
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    • pp.1-9
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    • 2016
  • Objectives: Objectives : This study is aimed to develop a Clinical Practice Guideline (CPG) on acupuncture treatment for the patients with Post-stroke Urinary Retention; PSUR. Methods: Experts committee, consisting of stroke or methodology specialists, searched Medline, EMBASE, Cochrane Library, China National Knowledge Infrastructure, and 19 Korean medicine journals. The search terms were selected to screen the randomized controlled trials (RCTs) or systematic reviews for the effectiveness of acupuncture on PSUR compared with placebo or conventional group. Levels of evidence and grades of recommendations were appraised based on Recommendations for Development of Clinical Practice Guideline in Korean Medicine. Results & Conclusions: 4 RCT were included to build the CPG. There was a strong evidence to support the effectiveness of acupuncture treatment for PSUR. The moderate evidence was presented that over 3 times a week of the acupuncture should be performed over 4 weeks on the acupoints, such as SP6, CV3, CV6, CV4, SP9, BL28, BL23, BL22, KI3 or BL67, for 15-30 minutes. 20-140Hz frequency and 10-20 minutes of treatment is suggested if electro-acupuncture treatment is performed with. It was also suggested that the procedure should begin at the acute stage just after the vital signs of the patients are stabilized. Finally, there was a moderate evidence to support safety of acupuncture treatment for PSUR.

The Trend of Clinical Research on Treatment for Pediatric Inguinal Hernia and Pediatric Rectal Prolapse - Focusing on Recent Studies in the China National Knowledge Infrastructure (CNKI) - (소아 서혜부 탈장(脫腸)·탈항(脫肛) 치료에 대한 중의학 연구동향 - 2000년 이후 발표된 RCT 논문을 중심으로 -)

  • Park, So Hyun;Kim, Ye Ji;Lee, Sun Haeng;Lee, Jin Yong
    • The Journal of Pediatrics of Korean Medicine
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    • v.34 no.2
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    • pp.40-56
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    • 2020
  • Objectives The purpose of this study is to analyze recent clinical studies on traditional Chinese medicine (TCM) treatment for pediatric inguinal hernia and pediatric rectal prolapse in China, and to seek better methods to treat and to study for Inguinal hernia and Rectal prolapse in Korea. Methods We searched the clinical studies from the China National Knowledge Infrastructure (CNKI) that were published between January 2000 to February 2020 by key words '疝气', '直腸脫出', '直腸脫垂', '脫肛', '小腸疝', '腹股溝疝', '儿童', '小儿', '少儿', '幼年', '治療', '中医治療', '中藥', '中医藥', '顆粒', '膠囊', '自擬', '湯', '丸', '散', '方'. We analyzed the literatures in regards to the treatment methods and results. Results Among the 193 searched studies, 10 randomized controlled trials were selected and analyzed. In most of the studies, the effectiveness of the traditional Chinese medicine (TCM) treatment on inguinal hernia and rectal prolapse was significantly high. Conclusions Based on the results of the clinical studies from China, use of the TCM for the treatment of inguinal hernia and rectal prolapse has been shown to be effective in relieving symptoms. Also, based on the result of this study, it will be possible to widen the scope of the TCM treatment on inguinal hernia and rectal prolapse. Additional clinical studies and experimental studies are needed to be performed to solidify these findings. The TCM has been shown as an effective treatment for pediatrics as well. These research results can be utilized in other clinical studies and in treatment.

A Review of Clinical Studies of Chinese Medicine Treatment of Polycystic Kidney Disease Using the CNKI Database (다낭신의 중의치료에 대한 임상연구 동향 - CNKI검색을 중심으로)

  • Ju, Ah-ra;Park, Mi-so;Choi, Yo-sup;Choo, Won-jung;Baek, Hye-kyung;Park, Mu-jin
    • The Journal of Internal Korean Medicine
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    • v.42 no.3
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    • pp.225-238
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    • 2021
  • Objective: This research reviews and investigates the trends in recent clinical studies of polycystic kidney disease (PKD) in China. Method: We searched for clinical studies discussing Oriental medicine-based treatments for PKD in the China National Knowledge Infrastructure (CNKI) database. Thirteen clinical articles published from 2001 to 2019 were analyzed. The search focused on the authors, publication year, type of study, purposes of study, method and duration of treatment, evaluation criteria, and results of the selected articles. Results: Of the articles from the database, 9 case series and 4 randomized controlled trials (RCTs) were analyzed. Ten articles used herbal medicine; 4 used herbal medicine for external use. Gamigyejibokryeong-hwan was the most common herbal prescription. The most frequently used herb was Polia Sclerotium (茯苓), and Cnidii Rhizoma (川芎) was employed in all the external uses. All 13 studies confirmed the efficacy of Oriental medicine treatments. Conclusion: 1. Scientifically designed and more varied clinical studies are required to develop treatments for PKD. 2. The current study could be used as basic data in future clinical studies on treatment and further studies of PKD.