• Journal of Society of Preventive Korean Medicine
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• v.28 no.1
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• pp.131-157
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• 2024

목적 : 본 연구는 감기에 대한 한약제제 임상시험을 수행하고 평가하는 데 보편적인 원칙을 제공하는 가이드라인 개발과정 및 내용을 소개하여 가이드라인 활용성 및 접근성을 높이고자 한다. 방법 : 임상시험 가이드라인 개발을 위해 총 9인으로 이루어진 위원회를 구성하고, 전반적인 절차를 수립하였다. 먼저, 가이드라인 집필위원회에서 관련된 국내외 가이드라인을 고찰하고, 감기에 대한 최신 임상시험 논문을 분석하여 초안을 완성하였다. 이후 대한한방내과학회 소속 전문가 자문위원회 검토 및 8인의 전문가로 구성된 협의회 자문을 통해 최종 가이드라인을 도출하였다. 결과 : 본 가이드라인은 (1) 일반적 사항 (2) 유효성 평가 기준 (3) 유효성 평가 방법 (4) 시험 대상자 선정 (5) 임상시험 설계 (6) 안전성 평가 (7) 감기 치료에서의 병용요법 (8) 한의학적 고려 사항의 8가지 범주로 나뉘어진다. 최종 개발된 가이드라인은 한의약임상시험센터 협의회와 대한한방내과학회의 인증을 득하였다. 결론 : 본 가이드라인은 감기 치료를 위한 임상시험을 수행하고 평가하는 데 유용하게 사용될 것이며, 이를 통해 신뢰할 수 있는 결과를 이끌어내고 정확한 해석을 용이하게 할 수 있을 것이라 기대된다. 또한 추후 해당 가이드라인 개정 및 관련된 호흡기질환 가이드라인 개발 과정에 도움을 줄 수 있을 것으로 사료된다.

• Analytical Science and Technology
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• v.24 no.2
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• pp.127-134
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• 2011

Quantitative HPLC analysis for the determination of in herbal liquid preparations was improved from the general test method besides the Korean Pharmacopeia. Good chromatographic separation of samples containing parabens, interferences, and other pharmaceutical excipients was effectively achieved by using acetonitrile water (containing 1% glacial acetic acid) mixture (30:70 v/v) as mobile phase. To monitor preservatives (benzoic acid, parabens, sorbic acid, dehydroacetic acid, and their salts) in herbal liquid preparations, a group of 47 samples was divided into two different group: preservative labeled group and unlabeled group. From the results, the contents of preservatives in 31 samples of preservative labeled group fell under KFDA regulations, and the contents of dehydroacetic acid in 6 samples of preservative labeled group were not followed by KFDA regulations. Preservatives were detected in 3 samples out of 10 samples in preservative unlabeled group.

• The Korea Journal of Herbology
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• v.29 no.1
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• pp.53-60
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• 2014

Objectives : Bojungikgitang (BJT), the Oriental medical prescription has been traditionally used about improvement of immune response and infective disease at Asian nation. In this study, we has compared about the anti-inflammatory and antioxidative effects on BJT of three countries including Korea (Korean Traditional Medicine, KTM), China (Traditional Chinese Medicine, CTM) and Japan (Japanese Traditional Medicine, JTM). Methods : We has basically using LPS-stimulated RAW 264.7 cells. The expression of these inflammatory mediators has measured using enzyme-linked immunosorbent assay (ELISA) and reverse transcription polymerase chain reaction (RT-PCR). Also, free radical scavenging assay has tested for anti-oxidative activity as well as the contents of total flavonoid and polyphenol. Results : As a result, we were founded the inhibitory effects of BJT (KTM, CTM, JTM) on LPS-induced production of NO, TNF-${\alpha}$ and IL-6 as well as the anti-oxidative activities. Especially the KTM was most effective in anti-inflammatory and anti-oxidative activities. Conclusions : These results indicate that BJT (KTM, CTM, JTM) has a good anti- inflammatory and anti-oxidative effects. But, there were degree of effects on between pharmacopoeia of the countries. Thus, further study is required that find appropriate methods for extracting as well as establish of standardized processes in order to improve the quality of BJT (KTM, CTM, JTM) as an anti-inflammatory and anti-oxidative agent for treatment of inflammatory diseases.

• The Journal of Korean Medicine
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• v.38 no.3
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• pp.124-142
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• 2017

Objectives: This study aimed to learn what should be considered in [Guideline of Clinical Trial with Herbal Medicinal Product for Gastric Cancer)] by analyzing the existing guidelines and clinical trials. Methods: The development committee searched guidelines for herbal medicinal product or gastric cancer developed already. Then, clinical trials for gastric 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 analysis with the regulations and guidelines of Ministry of Food and Drug Safety to suggest the issue that we will have to consider when making the [Guideline of Clinical Trial with Herbal Medicinal Product for Gastric Cancer]. Results: As a result, few guidelines for anti-tumor agent and clinical trial with herbal medicinal product were searched in the national institution homepage. In addition, 10 articles were searched by using the combination following search term; 'stomach neoplasm', 'herbal medicine', 'Medicine, Korean traditional', 'Medicine, Chinese Traditional', 'TCM', 'TKM', 'trial'. Most trials included gastric cancer participants with medical history of operation. The type of intervention was various such as decoction, granules, and fluid of intravenous injection. Comparators were diverse such as placebo, conventional treatment including chemotherapy and nutritional supplement. The most frequently used outcome for efficacy was quality of life. Besides, the symptom score, tumor response, and survival rate were used. Safety was investigated by recording adverse events. Conclusion: We found out some issue by reviewing the existing guidelines and comparing it with clinical trials for gastric cancer and herbal medicinal products. These results will be utilized for developing [Guideline of Clinical Trial with Herbal Medicinal Product for Gastric Cancer].

• Korean Journal of Oriental Medicine
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• v.7 no.1
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• pp.77-84
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• 2001

A survey was conducted to investigate the attitudes of pharmaceutical companies toward the status and permission of R & D of herbal products. The survey's results showed that some of them(42.9%) was conducting the R&D, and others(57.1%) were not conducting. As the results of analysis on the reason of R&D conducting, some of them(42.3%) answered that R&D of herbal products is more effective and powerful than these of synthetic products. And 23.1% answered that the cost of R&D is low and the time required is short. And another 23.1% answered that it has marketability and competitive power. As the results of analysis on the marketability of herbal products in Pharmaceutical Market, most of them(78.6%) answered that it seems enough. As the result of the comparison of synthetic drug and herbal products, the proportion of R&D investment on herbal products was lower than synthetic products in the preclinical study, the first clinical study and the second clinical study, and higher than in the third clinical study and the NDA. And the periods of R&D was long in most procedure except synthesis of new materials. As the results of analysis on the recognition of related regulation, most of them(73%) was yes. And 35.2% of the subjects thinks it enough.

• The Journal of Internal Korean Medicine
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• v.40 no.1
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• pp.89-116
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• 2019

Objective: This study aimed to ascertain what should be considered in the "Guideline for Clinical Trials with Herbal Medicinal Products for Liver Cancer," by analyzing existing guidelines and clinical trials. Methods: Committee for the development of a guideline, consisting of 6 Korean medicine doctors, reviewed guidelines and clinical trials on using herbal medicine for treating liver cancer. The trials were analyzed in terms of inclusion and exclusion of participants, intervention, comparators, outcomes, and trial design. We then compared the results of our analysis with the guidelines to identify issues we must to consider when following the "Guideline for Clinical Trials with Herbal Medicinal Products for Liver Cancer." Several guidelines for antitumor agents and clinical trials on herbal medicine were obtained from the Ministry of Food and Drug Safety homepage, etc. The search terms were as follows: "liver neoplasms"; "herbal medicine"; "medicine, Korean traditional"; and "medicine, Chinese Traditional.". Results: Ten articles were obtained from pubmed and Embase. There was no guideline for clinical trials on using herbal medicine for treating liver cancer. All the participants in the reviewed articles had primary liver cancer, and the type of intervention varied (e.g., decoction, patches, and capsules. The comparators included placebos and conventional treatments such as chemotherapy. The outcome assessment methods were tumor response, quality of life, survival, and liver function tests. Adverse events occuring during the trial were also evaluated. Conclusion: Findings were derived by reviewing existing guidelines and comparing them with clinical trials on liver cancer and herbal medicinal products. These results will be utilized in the development of the "Guideline for Clinical Trials with Herbal Medicinal Products for Liver Cancer."

• Journal of Oriental Neuropsychiatry
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• v.35 no.3
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• pp.217-229
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• 2024

Objectives: To develop guidelines for concomitant use of four herbal medicines (Gamisoyosan, Banhasasimtang, Ojeoksan, and Bojungikgitang) with escitalopram. Methods: A guideline development team was assembled and relevant prior research was systematically reviewed to gather evidence. The potential for drug interactions was evaluated by analyzing changes in pharmacokinetic parameters. Safety was assessed through the analysis of adverse drug reactions associated with combined use. Recommendations and concomitant administration guidelines were formulated through a consensus process. Results: No significant drug interactions were identified between the four herbal medicines and escitalopram, indicating no need for dosage adjustment of escitalopram. However, it is recommended to monitor potential adverse reactions during concurrent use. Conclusions: This study provides recommendations for combined use of four herbal medicines covered by domestic insurance combined with escitalopram. Further research on interactions between antidepressants and herbal medicine is necessary to refine and enhance concomitant administration guidelines.

• Herbal Formula Science
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• v.7 no.1
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• pp.89-98
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• 1999

We sometimes directed taking medicine by using decoction of Jujubae Fructus in taking herbs medicine. And I studied meaning on using decoction of Jujubae Fructus in taking herbs medicine. The obtained results were follows: 1. In taking medicine by using decoction of Jujubae Fructus, chief effect positions of that prescription were heart, spleen, stomach, and kidney. 2. In taking medicine by using decoction of Jujubae Fructus, chief treatment symptoms were heart throb, sleeplessness, reddish turbid urine, retention of phlegm and fluid, retention of fluid in the body, weakness. 3. In taking medicine by using decoction of Jujubae Fructus, chief pathogenic factors of that prescription were deficiency syndroms of the heart, retention of phlegm and fluid, retention of fluid in the body, consumptive disease, weakness.

• Herbal Formula Science
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• v.24 no.2
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• pp.71-79
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• 2016

Objectives : To verify the equivalence between Atractylodis Rhizoma Alba herbal prescription(HP-ARA) and Atractylodis Rhizoma Alba herbal sub stance(HS-ARA). Methods : Safety tests by microbial regulation and heavy metal analysis (total heavy metal, Pb, As) and a stability test by long term shelf test for HP-ARA according to notification of the Ministry of Food and Drug Safety were carried out. Then, multi component profile of HP-ARA and HS -ARA were analyzed by HPLC. Results : The safety and stability of HP-ARA confirmed by several tests. Correlation coefficient of equivalence of HP-ARA and ARA-HS showed 0.992. Conclusion : Based on this result of equivalence between HP-ARA and HS-ARA, HP-ARA can substitute HS-ARA used to make herbal medicines (herbal decoction, pills and powder).

• The Journal of Korean Medicine
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• v.21 no.2
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• pp.14-24
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• 2000

Objectives : To direct methods of management and development of herbs and their derived products, and at the end of this study to inform the process of making new herbal drug regulations in Korea. Methods : This study analyzed the regulations and laws of western medicine drugs. Results : We have got some herbal prescriptions which are not in the eleven books of oriental medicine now in use but which have proved effective. We need to establish standards for permissions to produce medical products through those prescriptions. Besides, we need the special permissions to produce herbal products through prescriptions, especially those which have been used to treat incurable diseases. And, we can contribute to globalization of oriental medicine and to well situating of herb products and medicinal acupunctures if we produce them according to international standards. It is thought that herbal medicine has no side effect in the medical society in Korea. But, it is getting popular to administer herbal medicine and western medicine together. Thus, the side effects of taking both medicines at the same time should be documented. Conclusions : Herbal medicines and herbal products should be under the control over the whole process of production, circulation, and sales. Now, it is time for herbal medicine to be known to all over the world. Therefore, herbal medicine must meet and adhere to the standards set by the western society and WHO.