• 동의생리병리학회지
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• 제32권4호
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• pp.291-297
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• 2018

The purpose of pilot clinical trial is to evaluate the efiicacy and safety of Needle-Embedding acupuncture therapy on TEWL(Transepidermal Water Loss) and Skin hydration. A total of 24 human who visited Dongshin Oriental Medical Center from December 1st, 2016 to July 31st, 2017 were included in the pilot clinical trial. Needle-Embedding acupuncture therapy performed at Gokji(LI11). We observed change of TEWL(Transepidermal Water Loss), Skin hydration before and after Needle-Embedding acupuncture therapy. In the primary endpoint, index of TEWL showed a statistically insignificant decline ($8.5{\pm}2.12{\rightarrow}7.8{\pm}1.53g/h/m^2$). Index of skin hydration showed a statistically significant result ($38.2{\pm}6.77{\rightarrow}36.8{\pm}6.64$). To evaluate the safety, Adverse events and Vital sign check were conducted and there were no problem. And when the physical response, self-awareness, skin system, musculoskeletal pain, and other abnormal responses were assessed 60 minutes and 24 hours and 7 days after Needle-Embedding acupuncture therapy at Gokji(LI11) for stability assessment, Adverse events disappeared during a pilot clinical trial. According to the above pilot clinical trial, it is suggested Needle-Embedding acupuncture therapy were effective for Skin moisturizing and safe.

• 동의신경정신과학회지
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• 제29권1호
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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.

• Journal of Acupuncture Research
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• 제30권3호
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• pp.109-115
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• 2013

Objectives : This study was aimed to find the motivation and satisfaction of subjects who participated in acupuncture and moxibustion clinical trials and to suggest ways to improve clinical trial management. Methods : We conducted a survey and collected the data of 233 subjects of acupuncture and moxibustion clinical trials from 6 university hospitals. Results : For all 233 subjects, the mean of the total satisfaction score was 4.07 (perfect score 5.0), and the score was particularly high in aspects of the investigator and clinical research coordinator, but low in the site and sponsor aspects. There were no differences in the satisfaction degree with general characteristics. The satisfaction degree of the acupuncture and moxibustion clinical trials was strong positive correlated with participation benefits(r=0.595) and easy contact with the research team (r=0.500). Conclusions : Most subjects showed positive perception and interest in the clinical trials. Future studies should investigate how personal factors influence the satisfaction of subjects, should identify a specific classification criterion, and create a standardized protocol for the clinical trials.

• 대한한방내과학회지
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• 제28권3호
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• pp.519-530
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• 2007

Objectives : The purpose of this study was to develop outcome indicators in clinical trials of herbal drugs effective for asthma. cough and sputum. To accomplish the objective, this study collected outcome indicators developed and used according to conventional medical concepts. Methods : Our research group reviewed SCI papers concerned with developing outcome indicators to evaluate amelioration of asthma, cough and sputum. We also reviewed clinical trials of herbal drugs effective for them. Results : To evaluate asthma, objective as well as subjective methods were chosen according to the purpose of each trial. Objective methods were PEF, FEVl, serum IgE, peripheral eosinophil counts, and so on. Subjective methods were symptom scores, symptom diaries, quality of life measures, etc. To evaluate cough and sputum, objective and subjective methods were also chosen. Objective methods were tussigenic challenges, sputum induction and computerized methodology, and subjective methods were similar to the methodology evaluating asthmatic symptoms. Conclusions : It is desirable for a clinical trial evaluating herbal drugs for asthma, cough and sputum to use objective and subjective outcome indicators together. However, biological outcome indicators, a kind of objective methods, can not be chosen as the purpose of trial. Valid and reliable subjective outcome indicators are needed to develop good clinical trials of herbal drugs effective for asthma, cough and sputum.

• 한방재활의학과학회지
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• 제20권2호
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• pp.63-77
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• 2010

Objectives : It is known that abdominal obesity increases the possibility of cardiovascular diseases, early death, and metabolic syndrome including dyslipidemia and insulin resistance. Clinical trials have been under way to verify the effectiveness of treatment for abdominal obesity. The objective of this study is to set criteria about how effective oriental medicine and acupuncture are in abdominal obesity. Methods : I manually search "www.clinicaltrial.gov", 4 Korean medical databases and 4 Korean medical journals of abdominal obesity. Search terms used were "abdominal obesity" or "visceral obesity". In order to see detail review, searching was performed from 01, 01, 2005 to 11, 31, 2009. And I classified all the searched studies into design, intervention, purpose, end point, diseases, condition and etc. Results : 1. I could search total 67 trials in "www.clinicaltrial.gov". I found 9, 10, 13, 8, 6 clinical trial from 2005 to 2009 every year. 2. Test on both gender and adult or adult and senior have been most frequent. 3. Randomization clinical trial is 51 cases that occupied 96.2%. 38 cases use control group. 4. Body mass index(BMI) and waist circunference(WC) are major criteria of abdominal obesity clincal trial. WC, BMI, abdominal fat mass, body weight are measured at end point of abdominal obesity clincal trial. 5. I could search total 86 cases in domestic study. I found 15, 23, 23, 20, 5 cases from 2005 to 2009 every year. 6. Test on female and adult have been most frequent in domestic study. 7. Randomization clincal trial is only 2 cases that occupied 2.3%. 62 cases use control group in domestic study. 8. BMI, body fat percent, WC, visceral-subcutaneous fat ratio(VSR), waist-hip ratio(WHR) are criteria of abdominal obesity clincal trial in domestic study. WC, BMI, abdominal fat mass, body weight are measured at end point of abdominal obesity clincal trial in domestic study. Conclusions : To improve abdominal obesity study in traditional korean medicine, it is need to activate clinical trial, meta analysis, develope of clinical practice guidelines, co-works with conventional medicine and etc.

• 대한한의학회지
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• 제31권1호
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• pp.122-129
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• 2010

Objective: To investigate institutional review boards and approved clinical trials of Oriental medical hospitals in Korea Methods: We e-mailed 16 Oriental medical hospitals a survey consisting of questions that addressed two topics, institutional review boards and the clinical trials they approved. The first part included questions about whether each hospital had an institutional review board, that board's staffing and education, reviews, and expedited reviews. The clinical trials portion covered the number and types of approved clinical trials, treatment methods, whether an investigator or a sponsor initiated the trials, diseases, time frame, and clinical trial fee. Results: We received a response to our e-mail from 14 hospitals, all of which had an institutional review board. The average number of institutional review board members was 13.57. Of these Oriental medical hospitals, 70% and 49% said that they regularly educated their institutional review board staff and clinical trial, investigators, respectively. 79% of the hospitals claimed to conduct regular reviews, and 50% said that they did so monthly. The number of approved clinical trials increased sharply from 11 in 2005 to 102 in 2008. 68% of these clinical trials were randomized, and the most-used treatment methods were herbal medicine (35%) and acupuncture (29%). The most common target diseases were circulatory (19%), urinogenital (14%), and musculoskeletal (13%) disease. Conclusions: Despite the rapid increase in clinical research in oriental medical hospitals, many more efforts including raising IRB quality, varying research diseases and increasing clinical trials in the hospitals located in non-metropolitan area, should be made.

• 대한한의학방제학회지
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• 제27권3호
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• pp.213-221
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• 2019

Objectives : The purpose of this study is to confirm the efficacy and safety of the treatment of gastritis with 'Hwangryunhaedok-tang'. Methods : Total 20 people, between 19 and 65 years old, will be recruited to participate in a comparative clinical trial. All subjects will take 2 capsules of Hwangryunhaedok-tang (Redoxin Cap.), 3 times a day, 30 minutes after meals, for 8 weeks. Outcomes will be measured at the baseline, 4th week, and 8th week. Primary outcomes is the improvement rates of gastritis symptoms, such as heartburn, nausea/vomiting, abdominal bloating, anorexia, heartburn, and trim. Results : This trial was approved by institutional review board of Pusan National University Korean Medicine Hospital (registry number: 2018011), and registered in Clinical Research information Service, one of WHO. Recruitment opened in April 2019 and is supposed to be completed by December 2019. Conclusions : This trial will provide clinical information to determine the efficacy and safety of treatment of gastritis with 'Hwangryunhaedok-tang'.

• 대한한방체열의학회지
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• 제7권1호
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• pp.1-13
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• 2009

Purpose: To evaluate the hot flush relief efficacy of Yiseontang-gami in climacteric women with hot flushes, a vasomotor symptom. Methods: The 20 subjects who signing on the clinical trial written consent by self-will is registered this clinical trial after decided suitable by selection and exception standard, after take a medical experiment and checkup according to clinical trial plan. Registered subject should valuated by settled schedule after take the testing medicine(Yiseontang-gami)during thirty-day. The evaluating indexes of this trial are hot flush VAS, hot flush frequency, hot flush consistence time, sweating VAS, palpitation VAS, sleep disturbance VAS, MRS, MENQOL, PGA. Results: The results were as follows 1. 4 subjects dropped out of the clinical trial and 16 subjects completed it. 2. After Yiseontang-gami treatment, hot flush VAS, hot flush frequent, sweating VAS, Palpitation VAS, sleep disturbance VAS improved significantly. 3. After Yiseontang-gami treatment, hot flush consistence time was not improved significantly. 4. After Yiseontang-gami treatment, blood test value were not different significantly. Conclusion: In this clinical trial we consider that Yiseontang-gami is suitable treatment for the hot flushes and related symptoms.

• Korean Journal of Acupuncture
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• 제24권3호
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• pp.33-45
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• 2007

Background : Hot flushes are general postmenopausal symptoms which about 75% of climacteric women undergo. They affect hotness, perspirations, systemic weakness, panic disorders, insomnia. Acupuncture is effective in alleviating hot flushes in practice. Assessment effectiveness and safety of acupuncture in hot flushes would be needed through multi-center trial. Objectives : Purpose of this study is to develope the protocol of effects of acupuncture on hot flushes, a postmenopausal symptom in climacteric women. Methods & Results : It will be a multi-centered, randomized, sham controlled, comparative trial. It will be performed by Good Clinical Practice after approval of Institutional Review Board. Selection criteria will be set according those of FDA above moderate degree. There will be a notice on concomitant medication, other herbs, dietary supplements. Superficial needling on sham points will be used for control group. Treatment period will be 8 weeks with 12 weeks' follow up. Some questionnaire scale will be used as the primary and secondary outcome. Conclusions : The clinical trials based on this protocol will be performed.

• 대한한방부인과학회지
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• 제19권4호
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• pp.205-215
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• 2006

Purpose : To identify factors related to the severity and frequency of hot flush of postmenopausal women who participated in a clinical trial. Methods : A cross-section study of 34 postmenopausal women between 40 and 60 years of age was done. VAS(visual analog scale) was used to evaluate the hot flush degree. Statistical analysis was performed with multiple linear regression analysis. Results : Hot flush VAS was proportional to the percent body fat with 1.467 regression coefficient (p-value= 0.010). It implies that the symptom of hot flush becomes worse as the percent body fat increases. Some hormones also have effects on hot flush. We found that LH might cause increment of hot flush VAS(i.e., the corresponding regression coefficient is 0.912). Sasang constitution was not relevant to the hot flush degree. Hot flush VAS seemed to increase as the vascular aging degree by SA-2000 getting worse, but it was not statistically significant (p-value= 0.594). Conclusion : This study is a part of a prospective clinical trial. For more accurate result, larger-scale cross-section study or clinical trial are necessary.