• Herbal Formula Science
• /
• v.19 no.1
• /
• pp.233-241
• /
• 2011

Objectives : This study was carried out to investigate the acute toxicity and safety of Ssanghwa-tang extract fermented with Paecilomyces japonica. Methods : To evaluate the acute toxity and safety, 0(control group), 1250, 2500 and 5000 mg/kg of Ssanghwa-tang and fermented Ssanghwa-tang extracts were orally administered to 35 male and 35 female ICR mice. After single administration, we observed number of death, general toxicity, changes of body weight, and autopsy. Results : Compared with the control group, we could not find any toxic alteration in all treated groups (1250, 2500 and 5000 mg/kg). Conclusions : $LD_{50}$ of Ssanghwa-tang and fermented Ssanghwa-tang extracts might be over 5000 mg/kg and it is very safe to ICR mice.

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

• Herbal Formula Science
• /
• v.16 no.2
• /
• pp.1-9
• /
• 2008

Objective : The purpose of this report was to provide the information about activity and safety of Ojeok-san by analyzing domestic/international papers about Ojeok-san. Methods : Domestic/international papers related to Ojeok-san were reviewed and analyzed. These papers were then classified by year, experimental method and subject. Results : The following results were obtained in this study. 1. The studies of Ojeok-san started from 1984 and has continuously increased. The studies were mainly focused on experimental models rather than clinical studies. 2. By subject, papers related to safety were most common with 5 papers among 20 papers. Besides there were papers related to efficacy of analgesic, anti-hyperlipidemic, anti-blood stasis and treatment for uterine myoma. 3. The papers related to safety were mainly focused on the effect of Okeok-san on liver function, renal function or metal concentration of organs such as blood, brain, liver, kidney and bone. Ojeok-san proved to be safe, but more clinical studies regarding the safety are needed hereafter. 4. Papers related to analgesic, anti-pyretic, anti-phlogistic activities of Ojeok-san were in vivo studies, and other papers were about anti-hyperlipidemic activity, apoptosis inducing activity on uterine myeloma cell line and anti blood static activity on hydrocortisone acetate induced blood statis model. 5. Case reports were about anti-lipidemia, analgesic effect for mastalgia/back pain and anxiety disorder due to climacteric changes. Conclusion : Ojeok-san is being used in various ways with analgesic, anti-pyretic, anti-phlogistic, anti-hyperlipidemic, anti-tumor or anti-blood statis activity. However, mechanism study should be conducted at the molecular biology level and more clinical studies on the efficacy of Ojeok-san are needed.

• Journal of Society of Preventive Korean Medicine
• /
• v.14 no.3
• /
• pp.27-35
• /
• 2010

Objective : This study was carried out to investigate the acute toxicity and safety of Insampaedok-san extract in ICR Mice. Methods : SPF ICR male and female mice were administered orally with Insampaedok-san extract of 0 (control group), 1250, 2500 and 5000 mg/kg. After single administration, we daily examined number of deaths, clinical signs, gross findings and changes of body weight for 14 days. Hematological parameters and isolated organ weights were determined after 14 days of administration. Results : No dead animal and no significant changes of body weights were found during experimental period. In addition, no differences were found between control and all of treated groups in clinical signs, organ weights and hematology, and other findings. Conclusions : Insampaedok-san extract did not show any toxic effects and oral LD50 values of the extracts was over 5000 mg/kg in ICR mice.

• The Journal of Korean Medicine
• /
• v.35 no.1
• /
• pp.114-123
• /
• 2014

Objectives: Evidence-based medicine(EBM) advocates the use of up-to-date "best" scientific evidence from health care research as the basis for making medical decisions. EBM also has been applied to traditional Korean medicine(TKM), especially in the field of safety. Recently, the standard prescription for TKM by Korea Institute of Oriental Medicine was published based on toxic index from various toxicity tests. However, there are some limitations when the results from the study based on EBM are applied in clinics. To overcome these imitations, the term "evidence-based practical medicine" was developed and defined as clinically applicable results from the study based on EBM. And safety classification for TKM was suggested as an example of evidence-based practical medicine. Methods: For safety classification for TKM, the data for $LD_{50}$(50% lethal dose), which was transformed to theoretical $LD_1$(1% lethal dose), was analyzed as one of tools for EMB study and divided by maximum dose used in clinics. Results and Conclusions: As a result, human equivalent dose(HED)-based MOS(margin of safety) for korean traditional medicine was calculated and used for safety classification with 5 categories. These categories would be helpful for oriental medicine clinicians to decide the increase and decrease of dosage according to various factors such as patient's sensitivity, potential toxicity of herbal medicines, clinician's experience for better cure. Thus, this safety classification provides some evidences enough that evidence-based practical medicine should be not the same with EBM and defined differently from EBM.

• The Korea Journal of Herbology
• /
• v.26 no.2
• /
• pp.39-43
• /
• 2011

Objectives : This study was conducted to evaluate the acute toxicity and safety of Ssanghwa-tang (Shuanhetang in Chinese, Sou-wa-to in Japanese) in Crl : CD Sprague-Dawley (SD) rat though the current regulatory guideline. Methods : In this study, 10 rats of each sex were randomly assigned to two groups of 5 rats each and were administrated singly by gavage at dose levels of 0 and 2000 mg/kg/day of ssanghwa-tang water extract (SHT). After single administration of SHT, mortalities, clinical signs, body weight changes, gross findings were observed for the 15-day period. Results : Acute toxicity tests revealed that a single oral administration of SHT at dose levels of 2000 mg/kg did not affect clinical signs, body weight, and gross findings, evaluating the safety of SHT. The SHT treatment did not result in any toxicologically significant changes in mortality, clinical signs, body weight changes. Conclusions : These results showed that the single oral administration of SHT did not cause any toxic effect at the dose levels of 2000 mg/kg/day in rats. In conclusion, the median lethal dose (LD50) of SHT was considered to be over 2000 mg/kg/day body for both sexes.

• The Korea Journal of Herbology
• /
• v.26 no.4
• /
• pp.101-107
• /
• 2011

Objectives : Socheongryong-Tang (小靑龍湯, SCRT) has been widely used to treat respiratory disease. In this study, we investigate the acute toxicity and safety of fermented Socheongryong-Tang extract. Methods : To evaluate the acute toxicity and safety, 0 (control group), 1250, 2500 and 5000 mg/kg of Socheongryong-Tang and fermented Socheongryong-Tang extracts were orally administered to male and female ICR mice. After single administration, we observed survival rates, general toxicity, changes of body weight for the 14 days and autopsy. Results : Compared with the control group, we could not find any toxic alteration in all treated group (1250, 2500 and 5000 mg/kg). Conclusions : $LD_{50}$ of Socheongryong-Tang and fermented Socheongryong-Tang extracts might be over 5000 mg/kg and it is safe to ICR mice.

• Korean Journal of Oriental Medicine
• /
• v.16 no.1
• /
• pp.135-140
• /
• 2010

This study was carried out to investigate the acute toxicity and safety of Ssanghwa-tang extract fermented with Ganoderma lucidum. To evaluate the acute toxity and safety, 0(control group), 1250, 2500 and 5000 mg/kg of Ssanghwa-tang and fermented Ssanghwa-tang extracts were orally administered to 20 male and 20 female ICR mice. After single administration, we observed survival rates, general toxicity, changes of body weight, and autopsy. Compared with the control group, we could not find any toxic alteration in all treated groups (1250, 2500 and 5000 mg/kg). $LD_{50}$ of Ssanghwa-tang and fermented Ssanghwa-tang extracts might be over 5000 mg/kg and it is very safe to ICR mice.

• The Journal of Korean Medicine
• /
• v.26 no.2 s.62
• /
• pp.152-165
• /
• 2005

Background: The use of herbal preparations as remedies for various medical conditions has continuously increased in Korea Large proportions of Korean patients use herbal medicinal products, folk remedies, and food supplements. However, studies on the safety of herbal products arc conducted on a less than sufficient basis even in the countries like Korea where herbal medicine is being used extensively. Some of the reports on the safety of herbs were done by the doctors of western medicine but lack of knowledge and misclassification led to misunderstandings. Objecitves: This study aims to review the recent evidences on hepatotoxic events associated with the use of herbal medicinal products, folk remedy, and food supplements. In the process, this review will grasp trends in this field of studies and will direct further researches into the right direction. Methods: Systematic literature searches were performed on MedRic and MEDLIS in Korea. Screening and selection of the articles and the extraction of data were performed independently by two of authors. There were no restrictions regarding the published date. In order to avoid bias, the articles written by medical doctors, not by oriental doctors were selected. 43 journals were chosen for the review. Results: Analyzing the number of journals, studies on the drug-induced liver injury were increased after the year 2000. The proportion of herbal and folk remedy associated hepatotoxic injuries in all drug-induced liver injury was $21.0\%-30.0\%$. But criterion for herbal medicine is rather vague and limited objective data hindered objectiveness. Few of single medicinal herbs and combination preparations were associated with hepatotoxic injuries. But because of lack of objectivity, further researches must be conducted to yield more concrete results. Conclusions: yield more concrete results. Incidence figures are largely unknown, and in most cases a causal attribution is not established. The challenge for the future is to systematically research this area, educate all parties involved, and minimize patient risks.

• Journal of Society of Preventive Korean Medicine
• /
• v.13 no.1
• /
• pp.93-103
• /
• 2009

Evidences from various countries suggest that toxic heavy metals in herbal medicine may constitute a serious health problem. In order to evaluate whether the toxic heavy metals caused by herbal medicine intake, blood samples collected from 222 patients taking herbal medicine were analyzed. In average levels of analyzed metals, $0.4{\sim}33.9%$ of total samples for 8 metals such as Cd, Co, Cu, Hg, Mn, Ni, Pb and Zn except Cr and Fe exceeded the upper limit for WHO reference value. In analysis of regression coefficients indicating the levels of metals increased or decreased after taking herbal medicine for one month, however, there were different aspects by intake types for herbal medicine. For example, the metals increased by taking decoction in blood samples were as follows; Cd and Pb whether Mn, Ni and Pb as increased metals were identified in the group taking pill and decoction(combined intake group). The odds ratio showing values higher than 1 indicating that people who take herbal medicine would have possibility higher for metal accumulation in blood than that from people who do not take herbal medicine. The metals showing the odds ratio higher than 1 were Hg and Ni in decoction group, and Cd and Hg in combined intake group. However, eight of the total, 10 metals showed the odds ratios lower than 1 by taking herbal medicine. Thus, this may explain the possible role of herbal medicine as a chelator for heavy metals in body.