• The Journal of Korean Medicine
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• v.40 no.1
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• pp.153-173
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• 2019

Objectives: This study aimed to ascertain what should be considered in the "Guideline for Clinical Trials with Herbal Medicinal Products for Lung Cancer" by analyzing the existing guidelines and clinical trials. Methods: The committee searched guidelines and clinical trials about herbal medicine for lung cancer. The searched trials were analyzed in terms of inclusion and exclusion of participants, intervention, comparator, outcomes and trial design. Then, we compared the results of our analysis with the guidelines to identify the issues we will have to consider when making the "Guideline for Clinical Trials with Herbal Medicinal Products for Lung Cancer". Several guidelines for anti-tumor agents and clinical trials with herbal medicine were searched on the national institution homepage. The search terms were as follows: 'lung neoplasm', 'herbal medicine', 'Medicine, Korean traditional', 'Medicine, Chinese Traditional' etc. Results: There was no guideline for clinical trial with herbal medicine for lung cancer. In addition, 7 articles were searched through database searching. All the participants had non-small cell lung cancer. The type of intervention was decoction. Comparators included conventional treatments such as chemotherapy. The outcome measurements used in the studies were quality of life, tumor response, and survival duration, etc. Safety was evaluated by recording adverse events and blood test. Conclusions: Findings were made by reviewing existing guidelines and comparing them with clinical trials for lung cancer and herbal medicinal products. These results will be utilized in the development of "Guideline for Clinical Trials with Herbal Medicinal Products for Lung Cancer".

• The Journal of Korean Medicine
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• v.40 no.1
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• pp.124-152
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• 2019

Objectives: This study aimed to ascertain what should be considered in the "Guideline for Clinical Trials with Herbal Medicinal Products for Colorectal Cancer" by analyzing the existing guidelines and clinical trials. Methods: The development committee searched guidelines for herbal medicinal products for colorectal cancer that have already been developed. Then, clinical trials for colorectal cancer using herbal medicine were searched. The searched trials were analyzed in terms of inclusion and exclusion of participants, intervention, comparator, outcomes and trial design. Then, we compared the results of our analysis with the regulations and guidelines of the Ministry of Food and Drug Safety in order to identify the issues we will have to consider when making the "Guideline for Clinical Trials with Herbal Medicinal Products for Colorectal Cancer". Several guidelines for anti-tumor agents and clinical trials with herbal medicinal products were searched on the national institution homepage. In addition, 12 articles were searched using a combination of the following search terms: 'colorectal neoplasms', 'herbal medicine', 'Medicine, Korean traditional', 'Medicine, Chinese Traditional', 'medicine, East Asian medicine', 'medicine, Kampo', etc. Results: The characteristics of participants were various, such as people with medical histories of surgeries or recurrent cancers or who complained of chemotherapy-induced side effects. The types of interventions were also various and included decoctions, powders, intravenous fluids, intraperitoneal injections and gargles. Comparators used included placebos and conventional treatments. The outcome measurements used in the studies were quality of life, symptom score, tumor response, and survival duration, etc. Safety was evaluated by recording adverse events. Conclusions: Findings were made by reviewing existing guidelines and comparing them with clinical trials for colorectal cancer and herbal medicinal products. These results will be utilized in the development of the "Guideline for Clinical Trials with Herbal Medicinal Products for Colorectal Cancer".

• Journal of Korean Medical classics
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• v.27 no.4
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• pp.181-198
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• 2014

Objectives : This study was to analyze definitions of herbal medicinal preparations, crude drug preparations, and new drugs from natural products in the relevant laws and regulations, understand the related problems, and propose directions for improvement. Methods : I analyzed the legal definitions in respect of herbal medicinal preparations, crude drug preparations, and new drugs from natural products in relevant laws and regulations since 1945, explained the problems, and suggested the solution-considering the academic stance of Traditional Korean Medicine and the dualistic medical and pharmaceutical system. Results : Regarding the current laws and regulations that are relevant to herbal medicinal preparations, we should 1) clarify the boundaries between the duty of physicians and that of pharmacists, 2) limit the principles of Korean Medicine as well as the contents of the related textbooks, 3) find a way to protect the intellectual property rights for herbal medicinal preparations, and 4) establish a separate standard for drug classification regarding herbal medicinal preparations. In case of crude drug preparations, we should 1) clarify the meaning and limitations of the phrase, "the point of view of Western medicine," and 2) establish a classification standard for drugs that are used in Korean Medicine and clarify the boundaries between herbal drug preparations and crude drug preparations. Furthermore, laws and regulations apropos of new drugs from natural products do not actually fit the concept of "new drug," and due to subordinate laws, a supplement to a new drug submission is contradictorily misclassified as a new drug from natural products. Conclusions : The problems of legal definitions of herbal medicinal preparations, crude drug preparations, and new drugs from natural products have emerged in the process of giving approval to drugs that are made of herbs and natural products under the dualistic medical and pharmaceutical System. Laws and regulations that differentiate the process of approving herbs that are used in Korean Medicine and the others should be established.

• Proceedings of the Korean Society of Veterinary Pathology Conference
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• 2002.11a
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• pp.5-6
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• 2002

In a comprehensive summary use and supplementation of some well defined natural herbal formulations in the European swine breeding and fattening is documented. Along with this data also the quality assurance, hygenic as well as the standards of efficacy of the formulations are presented. Series of experimental and development work over the last several years with universities, research institutes, veterinarians and feed industry proved that the application of such phylo-components (feed supplementation) result in to optimizing swine breeding practices. On the basis of 4 specific formulations tested and used in the European veterinary field most of the common problems of pig breeding and rearing can be successfully handled. Precisely, problems of fertility, respiration, diarrhea and stress; which are directly related to imerse losses in production, with poor quality of piglets associated with immune suppressions. Besides curing common symptoms, one of the most important aspect is of improvement in the self defence mechanism which results ultimately in to increased immunity, vitality and health of the animals; of course, thereby reducing the mortality which is the most economical problem observed in the animal health. Moreover, data presented here reflects on the fact that the use of such high quality alternative formulations successfully replace conventionally used antibiotics or hormonal therapies. They also work synergestically of as complementary in vaccination program or act as growth promoting agents on natural basis.

• Analytical Science and Technology
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• v.22 no.2
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• pp.128-135
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• 2009

This paper is the monitoring results of some heavy metals (lead, cadmium, arsenic, mercury) in herbal medicines and their intake rates. The monitoring of lead, cadmium, arsenic and mercury was carried out on 600 samples with 60 kinds of herbal medicines. And the transfer ratio of heavy metals in the water-boiled drinks w as calculated. The results show that lead was detected over the Maximum Residue Limits (MRL) in 10 samples (7 species). Cadmium was detected over the MRM in 69 samples (19 species). Arsenic was detected over the MRM in 3 samples (3 species). Mercury was detected over the MRM in 13 samples (10 species). We need continuously monitoring to ensure confidence and safety for these herbal medicines. In case of the water-boiled drink, average intake rates of lead, cadmium, arsenic and mercury are 9.77%, 6.72%, 26.1% and 6.79%, respectively.

• Korean Journal of Microbiology
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• v.47 no.3
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• pp.241-248
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• 2011

The use of synthetic additives for preservation and enhancement of the market quality of food products has been emerging as a societal issue in terms of safety as well as changes in consumption patterns. Various research related to natural additives is being conducted to address these issues. This study examined the antibacterial effects of 79 types of medicinal herbs used as oriental remedies on bacteria isolated from beverages of damaged marketable quality. The antibacterial effects of methanol extracts on 13 Bacillus sp. and three Paenibacillus sp. were evaluated. We found that 43 of the herbal medicines analyzed had antibacterial effects on the isolated bacteria. Of those, eight were selected, and their antibacterial effects were further examined using water, ethanol, methanol, and ethyl acetate as solvents. The results revealed that Prunus mume, Rhus javanica, and Coptis japonica had excellent antibacterial effects against the isolated bacteria. In particular, they exerted greater antibacterial effects when water and ethanol were used as solvents. This result indicates the possibility of developing natural additives using these substances. Since P. mume in particular, has not been sufficiently studied compared to other herbal medicines, it presents an opportunity for additional investigation and the possibility for development as a new product in the future.

• The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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• v.21 no.2
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• pp.94-101
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• 2008

Objectives : To discuss the types of control groups in randomized controlled trials (RCTs) of herbal medicine, and to provide suggestions for improving the design of control group in future clinical trials. Methods : We reviewed the 8 articles about clinical trial design of Chinese herbal preparation which were published from 2005 through 2008. We selected those articles from CNKI(中國知識基礎施設工程(http://www.cnki.net)). Results : It is necessary to have control group in randomized controlled trials(RCTs) of Korean herbal preparation. But there are problems in the selection of appropriate control group drug. This paper lists several problems about the choice of control drug and puts forward some proposals and countermeasures. There are problems such as ethics and manufacturing matching placebo and positive control herbal drug. Conclusion : To improve the quality of control group design, we introduce standard drug plus placebo drug method and add-on research for placebo control group design, double dummy technique, using negative control drug or composite control drug for active control group design.

• Korean Journal of Pharmacognosy
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• v.14 no.3
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• pp.125-129
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• 1983

To examine effects of oriental pharmaceutical preparations on immunity, four of such preparations which are currently being used were examined. After their fluid extracts were injected intraperitoneally to ICR mice, the counts of total cell number, PMN and macrophage in the peritoneal cavity were made by using non-specific esterase staining method, and plaque-forming cells (PFC) were measured by using the modified method of Cunningham and Jerne. The results showed that 'Bo-Jung-Ik-Ki-Tang', 'Ih-Jung-Tang', 'Ohn-Kyeong-Tang' and 'Ke-Ji-Bok-Ryeong-Hwan-Ka-Dae-Hwang' increased both the macrophages and the total cells of the peritoneal cavity and that these preparations increased the number of PFC in the spleen. Therefore the data indicate that they potentiate both of the cell­mediated and humoral immunities in the mice.

• Journal of Society of Preventive Korean Medicine
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• v.17 no.2
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• pp.129-138
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• 2013

Objectives : The discussion of enlargement of Korean Medical insurance has been existed since 1987. But it had less effects. For better discussion, we compared insured herbal extracts and clinical prescriptions. Methods : The database of insured herbal extracts and clinical prescriptions bas set up to compare the ratios of herbal weight and analyze indications of insured herbal extracts and diagnosis and chief complain of clinical prescriptions. Results & Conclusions : The most frequent insured herbal extract is Bojungiki-tang. Analysis about indications of insured herbal extracts and diagnosis and chief complain of clinical prescriptions is that Bojungiki-tang is used frequently for gastrointestinal diseases, pulmonary diseases, and not for diseases. Bojungikgi-tang is also used for muscloskeletal dieases, hemorrhage, and ischemia.

• Herbal Formula Science
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• v.18 no.1
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• pp.43-56
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• 2010

Objective : There is a growing need to expand or adjust insurance coverage of herbal prescriptions in National Health Insurance. The purpose of this study was to provide basic data for expansions or adjustments of 56 herbal prescriptions in the National Health Insurance. Method : We surveyed lists of 56 insurance-covered herbal prescriptions, non-covered company-produced herbal medicines and self-prepared herbal medicines in 531 traditional korean medical clinics by mail from 6/1/2008 to 12/9/2008. Result : Among the 56 Prescriptions, Ojeok-san was stocked in 66.7% of clinics (1st), Samso-eum ranked 2nd, Socheongnyong-tang ranked 3rd, Gumiganghwal-tang was 4th, Hyangsapyeongwi-san ranked 5th. Among the non-covered company-produced herbal medicines, Danggwisu-san ranked 1st, Gwakyangjeonggi-san ranked 2nd, Oryeong-san was 3rd, Bangpungtongseong-san was 4th, Maengmundong-tang ranked 5th. Among the self-prepared herbal medicines, Gongjin-dan ranked 1st, Soche-hwan was 2nd, Gyejibongnyeong-hwan was 3rd, Yeongsin-hwan was 4th, Palmi-hwan ranked 5th. Conclusions : It is reasonable to select frequently used company-produced or self-prepared herbal prescriptions in this stock rate survey for improvement of National Health Insurance coverage.