• CELLMED
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• v.10 no.1
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• pp.8.1-8.7
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• 2020

Aim:'Itrifal-e-Sagheer', a compound Unani formulation has been indicated in disease conditions simulating dyslipidemia. The present study was done to substantiate the efficacy of 'Itrifal-e-Sagheer' in dyslipidemia on scientific parameters. Materials and methods: A randomized, single blind, controlled, clinical trial was carried out on 30 patients of dyslipidemia who were randomly allocated into test (n = 15) or control (n = 15) groups. The test drug, Itrifal-e-Sagheer and control drug, Abana® were given to respective group for 45 days along with lifestyle modification. Results: The test drug significantly alleviated the symptoms of subjective parameters (palpitation, breathlessness and weight gain) (p<0.05). There was statistically significant reduction in lipid profile of the patients in test group (p<0.05) than control drug treatment. Conclusion: The study evidenced that Itrifal-e-Sagheer is potentially effective and safe in the treatment of dyslipidemia. However, a multicentric study with robust study design is required to generalize the results.

• Journal of Acupuncture Research
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• v.26 no.5
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• pp.105-116
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• 2009

The use of acupuncutre has been increased worldwide, and large number of researches on acupuncture with improved quality has been conducted. Nevertheless, results of acupuncture treatment in those research tend to show mixed results, while many patients continuously seek acupuncture treatment as an adjuvant or alternatives for their health. Researchers and clinicians relevant to acupuncture are faced at this problematic discrepancy between the results of acupuncture in clinical trial including an randomized controlled trial and those of day-to-day clinical practice. The methodology of pragmatic clinical trial seems to be one of the promising research tools administering this problem especially in the area of complementary alternative medicine and traditional Korean medicine. In this study we first reviewed articles on the pragmatic clinical trial, summarized the essential concepts of 'explanatory' clinical trial 'pragmatic' clinical trial and then presented recent recommendations and arguments on this issue. We also analyzed and compared two similar pragmatic clinical trial protocols to show the readers the complexity of research designing. We hope more researchers in traditional Korean medicine will be interested in the methodology of pragmatic clinical trials and this study will serve to produce various high-quality clinical trials.

• The Journal of Korean Medicine
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• v.28 no.4
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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 Korean Medicine Rehabilitation
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• v.20 no.4
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• pp.197-213
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• 2010

Objectives : The clinical trial was designed to investigate the safety and effects of Taeeumjowui-tang(Taiyintiaowei-tang) extracts on the change of the weight, body compositions, serum in obese patients. Methods : This was a 12-weeks, randomized, double blind, placebo-controlled clinical trial. Patients with a body mass index of either greater than $30kg/m^2$ or between 27 and $30kg/m^2$ with controlled hypertension, diabetes, hyperlipidemia were considered eligible. Participants of 41 obese patients were randomized either to Taeeumjowui-tang(Taiyintiaowei-tang)(23) or placebo(18). After 12 weeks of treatment, we measured anthropometric factors(weight, height, waist circumference, BMI(body mass index) etc.), abdominal fat area by CT(computed tomography)scanning, serum lipid(total cholesterol, tryglyceride, HDL-cholesterol, LDL-cholesterol), blood lever of variety(AST, ALT, BUN, creatinine etc.). Adverse events also evaluated. Results : After 12 weeks of treatment mean weight, waist-circumference, total cholesterol, LDL-cholesterol and score of KEAT-26 were significant changed in Taeeumjowui-tang(Taiyintiaowei-tang). There were no serious adverse events in either groups. Conclusions : There were limited in this study that is conducted within a short period of 12 weeks. but its weight and WC(waist circumference), WHR(waist hip ratio), total cholesterol, LDL-cholesterol and score of KEAT-26 loss effect was significant and it had few adverse events.

• Journal of Oriental Neuropsychiatry
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• v.20 no.4
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• pp.79-89
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• 2009

Objectives : To address suitable method for designing clinical trial intervening Traditional Korean Herbal Medicine on General anxiety disorder through the recent clinical research in Chinese Herbal Medicine. Methods : Randomized, controlled trials(RCTs) of treatment of general anxiety disorder intervening herbal medicine were searched through CNKI databases. We examined several item of studies and evaluated using Jadad scale. We searched articles in CNKI with the key word "General anxiety disorder or 廣範性焦慮症", among them we selected the clinical trial studies related with herbal medicine except for case reports, studies of acupuncture therapy or west medicines. Results : 11 RCT studies of herbal medicine met inclusion criteria. The Studies used CCMD-3, HAMA as inclusion tool and mainly HAMA as a evaluation tool. Studies were progressed for 2-8 weeks, mostly used various positive control. Experiment medicine were mainly 理氣劑, 安神劑. In most studies, experiment group made similar or higher efficacy in comparison with control group. Mean Jadad score of studies was $1.3{\pm}0.67$, and only one study was double-blinded among 11 studies. Conclusions : RCT studies on general anxiety disorder of chinese herbal medicine tend to focus on investigating effect of herbal medicine through setting positive control group with CCMD-3 and HAMA. But, most studies had low quality of trial, for lack of pattern identification, evaluation and inclusion tool of chinese medicine. Clinical trials of general anxiety disorder should provide good quality by randomization, double-blinding, and multi-site trial.

• The Journal of Korean Medicine
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• v.30 no.5
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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.

• The Journal of Pediatrics of Korean Medicine
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• v.26 no.4
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• pp.32-37
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• 2012

Objectives: The purpose of this study was to obtain some understanding about Korean medicine treatment on language disorder in cerebral palsy for future practice and the research, from the clinical studies. Methods: The literature was searched using the database-China Academic Journals (CAJ). Clinical studies of Korean medicine treatment for language disorder in cerebral palsy, including Randomized controlled trial (RCT), case control study, case series, case report were analyzed. Results: Fifteen Clinical studies met our inclusion criteria; One case study and six case series, one non-randomized controlled trial and seven RCTs. Acupuncture treatment, especially Head acupuncture, was the major treatment for language disorder of cerebral palsy in clinical studies, as it was used in fourteen studies. Acupoint massage, tuina, and acupoint injection were employed as treatment methods in the studies. Acupuncture treatment was used for language disorder of cerebral palsy combined with language therapy and other rehabilitation treatment in many studies. The effectiveness in the treatment groups, regardless of treatment methods, was higher than that of control group in all RCT studies. Conclusions: The results of this study could be used in the practice and the future study about language disorder of cerebral palsy.

• Korean Journal of Acupuncture
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• v.32 no.1
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• pp.1-12
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• 2015

Objectives : The purpose of this study was to review the acupuncture and moxibustion therapy for gastroesophageal reflux disease(GERD) in China. Methods : The literatures were searched using the database-China Academic Journals(CAJ)(~2015.1.). Clinical studies of acupuncture and moxibustion therapy for GERD such as randomized controlled trial(RCT), non-randomized controlled trial(NRCT), case series, or case report were included. Results : Thirty studies met our inclusion criteria: 24 RCTs, 4 NRCTs, 1 case series, 1 case report. Various kinds of treatment such as body acupuncture, abdominal acupuncture, acupuncture therapy with finger on back-shu point, electroacupuncture, acupoint injection, auricular acupuncture, and moxibustion were used in the clinical studies. The treatment groups take herbal medicines at the same time in 16 studies, and proton pump inhibitor(PPI) and histamine 2 receptor antagonist were used as a comparative treatment in the most of studies. Acupuncture or moxibustion treatments were done daily or 2~3 times a week for 5 days~18 weeks. All of studies reported higher effective rate in the acupuncture or moxibustion treatment group compared to the western medication control group. Conclusions : The results of this study could be used for the future practice and the clinical research about the acupuncture and moxibustion therapy for GERD.

• Korean Journal of Acupuncture
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• v.28 no.4
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• pp.147-158
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• 2011

Objectives : The purpose of this study was to obtain some knowledge about the acupuncture treatments on Parkinson's disease for the future practice and the research from the clinical studies in China. Methods : The literatures were searched using the data base-China Academic Journals (CAJ) (1994-2011). Clinical studies of acupuncture for Parkinson's disease such as randomized controlled trial (RCT), non-randomized controlled trial (NRCT), case series, case report were included. Results : Of 145 articles, 52 Clinical studies met our inclusion criteria: 20 RCTs, 7 NRCTs, 22 case series and 3 case reports. Various kinds of acupuncture treatments such as scalp acupuncture, body acupuncture, abdominal acupuncture, acupoint injection, eye acupuncture and thick needle acupuncture (粗鍼) were used in the clinical studies. The treatment and control groups take Madopa Tablet (Levodopa + Benserazide HCl) in the same time in many studies, and Madopa treatment was used as a comparative treatment in the most of studies. Acupuncture treatment was done daily or 2~3 times a week for 2~20 weeks. All of studies reported high effective rate in the treatment group compared to control group. Conclusions : The results of this study could be used for the future study about the acupuncture therapy for Parkinson's disease.

• The Journal of Advanced Prosthodontics
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• v.5 no.2
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• pp.204-208
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• 2013

PURPOSE. The purpose of this study was to evaluate the effectiveness of a promotion campaign for subject recruitment and selection, and reasons of withdrawal from a prospective clinical trial of mandibular two-implant supported overdenture. MATERIALS AND METHODS. The subjects of this study were participants in a randomized controlled clinical trial for investigating prognosis of implants and overdentures with attachments. Recruited subjects were classified by gender, age, and participation motives. Withdrawal rate of the participants before and after enrollment were evaluated. RESULTS. 177 patients were recruited and 51 patients were enrolled for the trial. Among them, 40 participants eventually took part in the trial. 116 subjects (65.5%) were recruited by advertisement and 61 (34.5%) were referred by patients of the hospital or local clinics. Regarding recruitment effectiveness, newspaper recruited the largest number of participants. With respect to referral patients, the proportion of our hospital patients was higher (37/61). Subjects in their 70s comprised the largest proportion (22/51). The male to female ratio was similar (25:26). Final withdrawal rate of all subjects were 74.0%. Among the reasons for withdrawal from enrollment (n=126) presence of remaining teeth and lack of motivation were the most common reasons. CONCLUSION. To facilitate recruitment of clinical trial subjects and improve enrollment rate, it is important to obtain a sufficient number of researchers, perform promotion activity with diverse strategies, cooperate with local dentists, increase the research funding, and alleviate subjects' fear against clinical trials by thorough consultation.