• Journal of Sasang Constitutional Medicine
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• v.25 no.4
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• pp.373-383
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• 2013

Objectives The purpose of this clinical trial was evaluate the safety and efficacy of Mahwangjeongcheon-tang (MJT). Methods Twenty six volunteers were recruited as subjects. They were divided into two groups, which were MJT test group and placebo group. The investigated items related to the safety were the weight, the results of renal function and liver function. The investigated items related to the efficacy are the results of the spirometer, the clinical asthma measurement scale in oriental medicine-V (CAMSOM-V) and the quality of life questionnaire for adult Korean asthmatics (QLQAKA). Results There are no difference in the weight, the results of the renal functions and the liver functions between MJT test group and placebo group. There are the some differences in the result of the questionnaires related to the efficacy between MJT test group and placebo group. The significant difference were observed in the CAMSOM-V at the 4th visit. Conclusion MJT is the safe and effective herbal prescription that is useful to the asthma patients.

• Korean Journal of Pharmacognosy
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• v.51 no.3
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• pp.207-216
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• 2020

The analysis method for qualitative analysis of the screening method that can be performed prior to the quantitative analysis of individual pesticide was reviewed in order to meet the safety standards that are being strengthened in the field of pesticide residue testing of herbal medicines. Among the residual pesticides presented in the Korean Pharmacopoeia, 56 pesticides, excluding 15 pesticides that need to be individually analyzed, were selected for analysis using QuEChERS preprocessing and GC-MS/MS, which are used in the existing agricultural products field. For each pesticide, the detection limit level of 0.001-0.005 mg/kg and the quantitative limit level of 0.002-0.017 mg/kg were confirmed. In the recovery test in which the standard was treated at a concentration of 0.02 mg/kg, it was confirmed that the proportion of pesticides satisfying the recovery of 70-120% was 85.7-96.4% for each herbal medicine, so it was confirmed that it was a level that could be reviewed by the screening method.

• The Journal of Internal Korean Medicine
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• v.34 no.2
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• pp.192-203
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• 2013

Objectives : To investigate the incidence of drug-induced liver injury (DILI) by combined-prescription of Korean herbal medicine (KHM; prescribed herbal medicine by doctors of traditional Korean medicine) and Western medicine on liver function. Methods : Sixty-nine in-patients who took KHM and Western medicine for various conditions were enrolled for prospective observational study. All subjects were given liver and renal function tests at the start of hospitalization to establish a baseline. After taking KHM and Western medicine, tests were done at approximately 4-week intervals afterwards. Results : Fifty-three subjects showed normal liver function test (LFT) at baseline, 50 subjects (72.5%) remained within the normal range at the second test, while 3 subjects (4.3%) tests revealed slight increase of LFT. However not a single patient had a high enough raised LFT to indicate liver injury. Sixteen of 69 subjects had abnormal baseline, 11 subjects recovered to normal levels and 5 subjects remained at abnormal level. Among all subjects, there was no statistically significant increase in LFT level between the first and second tests. Conclusions : This study shows that the combined-prescription of KHM and Western medicine did not cause any DILI. In some cases, combined treatment increased LFT levels but those increases were not high enough to have statistical significance. Additional large scale and systematical studies are required for more conclusive proof and results.

• The Journal of Internal Korean Medicine
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• v.28 no.2
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• pp.363-376
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• 2007

Objectives : This study was undertaken to learn what should be considered in a good clinical trial investigating a herbal medicine as an antidepressant. Methods : Five well-designed clinical trials published from 2000 to 2006 investigating SJWE in depressive disorder were selected. The trials were reviewed and compared in terms of methodology such as trial design, patient selection, efficacy & safety evaluation, and so on. On the basis of this review of the trials and the regulations and guidelines of KFDA, we suggest some points to be considered for a good clinical trial of a herb for depression. Results : Although every trial had its own unique design, procedure, objectives and so on, all trials used randomizing and double blinding methods. If there is no ethical problem, a placebo-controlled design should be considered in a herbal antidepressant clinical trial for depression. Conclusions : Some points to be considered in an optimal & good clinical trial for an antidepressive herbal medicine were suggested as follows: 1) randomizing and double blinding manner is essential, 2) if there is no ethical problem, placebo control design should be considered, 3) the trial period should be 6 weeks, 4) out-patients will be recruited as subjects, 5) investigators will be well-trained psychiatrists or medical doctors, 6) the number of subjects should be calculated by statistical methods, 7) subjects should be diagnosed by DSM-IV criteria, 8) subjects who have current risk of committing suicide should be excluded, etc.

• The Journal of Korean Medicine
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• v.27 no.1 s.65
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• pp.1-10
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• 2006

Objectives : The combined treatment (CT) with oriental herbal medicine and western biomedical medicine is prevalent in the world including Korea. But the clinical information on frequency, efficacy and safety of CT at lout cerebrovascular attack hat not known thoroughly yet. This study aimed to identify the status and adverse effects of CT for the treatment of stroke patients. Methods : A self-completed questionnaire survey and medical record survey by oriental medical doctors were performed in 20 Korean Oriental medical hospitals. Of the initial 1,000 in-patients through 2-stage sampling method, 883 were participated in this surrey, resulting in a response rate of 88.3%. Results : Among stroke patients, the proportion of CT was 94.1%. 156 respondents (18.8%): were experienced several adverse effects including headache, dizziness (fatigue), diarrhea, constipation, chest discomfort, etc. The severity of these adverse effects was generally mild to moderate. Although they quitted the CT, 9.8% of patients were not relieved from adverse effects. Conclusions : This study suggests that most patients in Korean Oriental medical hospitals used the combined treatment with oriental herbal medicine and western biomedical medicine for management of stroke. Therefore, the medical professionals should provide comprehensive and up-to-date clinical information about potential benefits and risks of CT to the stroke patients.

• Journal of Society of Preventive Korean Medicine
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• v.15 no.3
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• pp.153-162
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• 2011

Objectives : This study has aimed to monitor microbial detection on pill types of herbal medicine which are circulating in markets including Oriental Medical Clinics(O.M.C.s) and Pharmacy in Korea. Methods : 10 different samples of O.M.Cs and 10 different samples of Pharmacy were investigated by culture method and non-culture method based on the 9th edition of microbial examination released by Korea Food & Drug Administration. Results : The total microbial count among each 10 samples were detected within the limit suggested by WHO. 2 samples of O.M.C.s and 1 samples of Pharmacy exceeded WHO's limit in fungi count. No samples exceeded WHO's limit in bacteria count. Most bacteria founded in samples were the phylum of Firmicutes and Proteobacteria which are common in soil by non-culture method. Conclusion : Further study should be followed to set up proper microbial limit of herbal materials including pill types.

• The Journal of Korean Obstetrics and Gynecology
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• v.33 no.2
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• pp.112-123
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• 2020

Objectives: The purpose of this study is to review the research in the cyclic treatment of endometriosis in traditional Korean medicine. Methods: By October 2019, the relevant studies on the periodic therapy of endometriosis were searched using the Chinese National Knowledge Infrastructure Database (CNKI) and Oriental Medicine Advanced Searching Integrated System (OASIS). Results: Finally, three Randomized controlled trials, one case study, two clinical observational studies were selected. In all studies, herbal medicine periodic therapy has been effective in improving symptoms of endometriosis. Blood-activating and stasis-dispelling medicinal were the most commonly used before menstruation and during menstruation, and tonifying and replenishing medicinal were the most commonly used after menstruation. According to the one study, which reported safety, herbal medicine was safe. Conclusions: Although limited due to a lack of literature, periodic therapy is effective in improving endometriosis related symptoms and preventing recurrence. A well-designed study and experimental studies for the identification of the mechanism are needed.

• The Journal of Internal Korean Medicine
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• v.41 no.6
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• pp.959-966
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• 2020

Objectives: To examine the fundamental characteristics of interventional clinical trials registered in the CRIS (Clinical Research Information Service) database. Methods: We systematically analyzed the status of Korean medical interventions using the search function of the CRIS database. Results: From 2010 to January 2020, 267 Korean medicine-related clinical trials were registered with CRIS. The studies, which included many randomized trials (80.14%), focused primarily on demonstrating the effectiveness and safety of acupuncture and Korean herbal remedies. Most of these studies were government-sponsored and researcher-led clinical trials, but a few were company-sponsored trials. All trials were small and need improvement. Conclusion: This study reviews the current status of clinical trials in the field of Korean medicine and the basic data that can be used to create evidence-based Korean medicine.

• Journal of Acupuncture Research
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• v.34 no.1
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• pp.59-66
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• 2017

Objectives : This study aims to report the effectiveness and safety of Korean medicine with thread embedding acupuncture in the treatment of trigeminal neuralgia (TN). Methods : A 73-year-old man who had suffered from severe facial pain for one year and who had had a healthy tooth extracted due to the pain is reported. He could not eat or sleep due to the severe pain. Acupuncture, thread embedding acupuncture, cupping, herbal steam, and herbal medicines were used for the treatment. Numeric Rating Scale (NRS) and adverse events were checked daily, and other outcomes (Baseline Evaluation, Visual Analogue Scale [VAS], Short Form Health Survey 36-Bodily Pain [SF-36 BP], and Patient Global Assessment [PGA]) were measured at hospital admission and discharge. During the follow-up examinations, his pain was evaluated roughly, without using any formal measurements, on the basis of a global assessment. Results : All measured parameters, including pain, quality of life, and patient satisfaction were noted to have improved at the time of discharge compared to admission: VAS from 10 to 1.5, NRS from 7-8 to 1-2, and SF-36 BP from 0 to 22.5, and the patient's global assessment was somewhat improved. He did not take any analgesics after discharge and noted only mild adverse events, like pain where the acupuncture and thread embedding acupuncture needles were inserted. His pain relief was maintained for 6 months. Conclusion : Korean medicine with thread embedding acupuncture might be a safe and effective treatment for TN. In the future, larger sample sizes and high quality randomized clinical trials are warranted to confirm its efficacy and safety.

• Journal of Korean Medicine Rehabilitation
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• v.27 no.4
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• pp.33-53
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• 2017

Objectives This study was designed to review animal studies about the efficacy of herbal medicine for Rheumatoid arthritis animal model which was published in Korea after 2008. We also systematically investigated the reporting quality of the animal studies. Methods We systematically searched original articles in 8 databases since 2008. And manual searching was conducted through 10 Korean medicine journals from 2008. Studies were included if they used animal experimental model(s) with orally administered herbal medicine. Data were extracted regarding animal model, rheumatoid arthritis indicator and detail of intervention. Reporting quality of each study was also assessed by the STARA and ARRIVE guidelines. Results Nine hundred two articles were screened. Finally, 35 articles were included. 35 studies all showed that the herbal medicine used in the studies has significant effect on alleviating the macroscopic indicators, hematological indicators, histological indicators, genetic indicators, osteological indicator of Rheumatoid Arthritis and others. Species of animals was reported in 100% while ventilation and noise were reported in 0% in STRASA guidelines. Ethical statement was reported in 42.9%, experimental animals and sample size were reported in 24%, 29% and there was no study reporting funding. Conclusions These results suggest that herbal medicine might be effective treatment for Rheumatoid Arthritis. It should be improved by clinical studies. And there is a need for studying about efficacy and safety of each specific herbal medicine. And we should improve the Reporting quality of the animal studies published in Korea.