• Herbal Formula Science
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• v.18 no.2
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• pp.159-166
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• 2010

Objective : The objective of this study was to evaluate the single dose oral toxicity of Hwangryundaedok-tang extract in ICR mice. Methods : 0(control group), 1250, 2500 and 5000 mg/kg of Hwangryundaedok-tang extracts were orally administered to 20 male and 20 female ICR mice. After single oral administration of Hwangryundaedok-tang extract to ICR mice, we observed number of the death, clinical signs, changes of body weights for 14 days. After 14 day of Hwangryundaedok-tang extract administration, all mice were sacrificed and major organs were observed. Results : Compared with the control group, we could not find any toxic signs in the mortalities, clinical signs, body weight changes, necropsy findings and hematological values in all treated groups(1250, 2500 and 5000 mg/kg). Conclusions : $LD_{50}$ value of Hwangryundaedok-tang extracts may be over 5000 mg/kg and it may have no side toxic effect to ICR mice.

• Journal of Acupuncture Research
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• v.21 no.3
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• pp.265-282
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• 2004

Objective : The aim of this study was to review systemically clinical trials on the effectiveness and safety of herbal medicines in the treatment of osteoarthritis. Methods : Computerized literature searches were carried out on seven electronic databases, and hand-searching on some chinese medical journals in library of Kyung Hee Medical Center. Trial data were extracted in a standardized, predefined manner and assessed independently. Results : 1. Thirty reports of clinical trials and two reports of meta-analyses concerning herbal medicine were collected and reviewed. Among these reports three medical herbs were applied as topical medicine and others as internal medicine. 2. The western studies established NSAIDs or placebo as their control group. Five chinese reports established formulated herb pill(Ruanshnagshenjin pill) as their control group and Six did not establish a control group at all. 3. ACR was the most highly used diagnostic criteria in the western studies while the Chinese used their official criteria established by their government or the criteria of their text books. 4. 20 reports chose the Lequesne functional index, SHAQ, WOMAC OA index, AIMS, and their own unique scoring system as the criteria of analysing the effect. Others chose clinical symptoms, articular functions, and lab finding as their criteria. 5. 7 single herbs and 19 formulated herbs were studied. Among the formulated herbs, Achyranthes japonica was studied in 10 of the studies and Angelica gigantis Radix in 8, making them the most often studied herbs among the studies.

• The Journal of Korean Obstetrics and Gynecology
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• v.26 no.4
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• pp.1-13
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• 2013

Objectives: In this study, it was carried out to evaluate the acute oral toxicity of Root of Polygala teunifolia Willd. in Sprague-Dawley (SD) rats. Methods: Male and female rats were administered orally with Root of Polygala teunifolia Willd. water extract of 1,000 mg/kg (low dosage group), 2,000 mg/kg (middle dosage group) and 4,000 mg/kg (high dosage group). We daily observed number of deaths, clinical signs and gross findings for 7 days. After 7 days, we measured body and organs weight. Also we analyzed hematological changes. Results: No dead SD rats and no clinical signs were found during the experiment period. Also other specific changes were not found between control and treated groups in hematology and serum biochemistry. But we found out histopathological changes in liver fat tissues of female. In addition, there were no significant changes of gross body and individual organs weight. Conclusions: These results suggest that water soluble extract of Root of Polygala teunifolia Willd. has not acute oral toxicity and oral $LD_{50}$ value was over 4,000 mg/kg in SD rats.

• Health Policy and Management
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• v.16 no.1
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• pp.1-16
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• 2006

Recently, there has been prevailing of the combined utilization (CU) with herbs and prescribed drugs in medical therapies in the world. But the information about frequency, efficacy and safety of this CU has not well known in Korea, yet. This study aimed to identify the status of CU by Koreans, and to inquire which side effects of CU represent to those people. A self-completed questionnaire survey was performed through each health examination center in twenty general hospitals and one oriental hospital. Of the initial 2,100 health examinees, 1,851 were participated in this survey, resulting in a response rate of 88.1%. The proportion of CD was 26.3%. The most commonly mentioned reason of CD was 'to promote general health and well-being' (17l persons, 35.5%). The main route of taking CD was self-purchase at drugstore or at herbs market, followed by the prescription of (oriental)physicians. 33.0% (151 persons) of those who took the CD rated it as effective. 93 respondents (19.8%) were experienced several adverse effects including nausea, fatigue, and dizziness. The growing simultaneous use of herbal products and pharmaceutical drugs by Korean consumers may be continuously increased the risk of herb-drug interactions. The medical professionals should be provided with comprehensive and up-to-date information about potential benefits and risks of herbs and prescribed drugs. In the future studies it may be recommended to deal common cold, health promotion, indigestion, headache, and hypertension for the effect and safety of the CD by well-organized prospective study design.

• The Journal of Korean Medicine
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• v.27 no.3 s.67
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• pp.151-168
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• 2006

Objectives: To help the Oriental medicine clinical studies for the common cold treatment, this study analyzed the tendency of research into complementary medicine on the common cold recently published in PubMed. Methods: This study analyzed 26 research papers on complementary medicine on the common cold published in PubMed Over the past 10 years. It measured annually and for each country the number of papers published, the number of subjects, the period of research, the area of trial, the method of study, the objective of study, and intervention, respectively and intervention, the objective of study, and the result of trials overall. Results: There were research papers concerning treatment, prevention, safety of herbal medicine, inducement, and improvement of symptoms of the common cold in the study objective the most among them concerned treatment of the common cold. There were more positive results compared to negative results for treatment and prevention. The results for safety and symptom improvement were positive, while the results for the inducement were indeterminate. There were research papers about using food and medicine, acupuncture, hydrotherapy, and cold exposure in intervention the most among them were about using food and medicine. The food and medicine interventions were Echinacea preparations, vitamins, zinc preparations, Baptisia, Thuja, the root of North American ginseng, probiotic bacteria, troxerutin, garlic, Andrographis paniculata, and caffeine. The use of Echinacea preparations was the most frequent among them. Conclusions: Recent research results of complementary medicine on the common cold were more positive than negative.

• The Journal of Korean Obstetrics and Gynecology
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• v.26 no.4
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• pp.48-65
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• 2013

Objectives: We took breast milk samples and analyzed them using HPLC and LC/MS/MS, to evaluate the effects of taking Saenghwa-tang during breastfeeding on breast milk. Methods: The study participants were 20 lactating women who admitted in Korean medical postpartum care center. Breast milks were collected from paticipants who have been administrated Saenghwa-tang for more than 3 days. We used HPLC and LC/MS/MS for the determinations of amygdalin, liquiritins, 6-gingerol, decursin and decursinol angelate in Saenghwa-tang. Results: 1. Participants' $Mean{\pm}S.D$ (standard deviation) of age is $31.05{\pm}1.96$, and 15 participants had normal delivery and 5 participants had cesarean delivery. 12 participants were primipara and 8 participants were multipara. $Mean{\pm}S.D$ of lactating date is $9.4{\pm}0.94$. 2. Using HPLC, we learned LOQ level peak that matches the peak retention time of standard components of Saenghwa-tang was not detected from 20 breast milk samples. 3. Using LC/MS/MS, decursin of Angelicae Gigantis Radix was detected from HMSP 02, HMSP 04, HMSP 06, HMSP 11, and the each concentrations are 16, 2, 64, 11 ppb. Liquiritin of Glycyrrhizae Radix was not detected from HMSP 13~HMSP 18. Conclusions: Data obtained by this approach shows that this method is reliable and suitable for determining the safety of taking Saenghwa-tang during breastfeeding.

• Herbal Formula Science
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• v.21 no.1
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• pp.186-199
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• 2013

Objectives : The objectives of this study was to obtain acute information (single oral dose toxicity) of Red-Koji (Monascus purpureus 12002) Fermented Scutellariae Radix Aqueous Extracts (fSR), has been traditionally used in Korean medicine for treating various diseases including inflammatory diseases. Methods : In order to observe the 50% lethal dose (LD50), approximate lethal dosage (ALD) and target organs, fSR powders were once orally administered to female and male ICR mice at dose levels of 2,000, 1,000, 500 and 0 (control) mg/kg (body weight.). The mortality and changes on body weight, clinical signs and gross observation were monitored during 14days after single oral treatment of fSR with organ weights and histopathological observations of 12 types of principle organs. Results : After single oral treatment of fSR, we could not find any mortality and toxicological evidences up to 2,000 mg/kg treated group, the limited dosages in rodents, on the body and organ weights, clinical signs, gross and histopathological observations, except for some accidental findings. Conclusions : The results obtained in this study suggest that the LD50 and ALD of fSR in both female and male mice after single oral treatment were considered as over 2,000 mg/kg because no mortalities were detected up to 2,000 mg/kg and can be safety used in clinics.

• Journal of Korean Medicine for Obesity Research
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• v.24 no.1
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• pp.94-101
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• 2024

Herbal medicine (HM)-containing Ephedra Sinica (ES) has been associated with false-positive amphetamine immunoassay (FP IA) results. This study retrospectively evaluated the effects of dose, duration, and withdrawal instructions on FP IA and the safety of HM-containing ES at a clinic in Seoul from 2022 to 2023. The study included 6 patients in the FP IA group and 5 patients in the withdrawal instruction negative (Neg) group. The pre-test ephedrine alkaloids dose in the FP IA group was 95.17±31.90 mg, compared with 88.6±20.43 mg in the Neg group. The FP IA group had taken HM for 226.67±152.87 days before testing, and testing was performed while taking HM. In contrast, the Neg group had taken HM for 147.6±23.49 days and had 5.4±1.50 days of withdrawal period before the test following instructions of Korean medicine doctors. All adverse events (AEs) were moderate in severity, and the number of occurrences was similar: 5 in the FP IA group and 7 in the Neg group. AEs included constipation, insomnia (3 cases each), and palpitations (2 cases). The results of this study show that ES-induced FP IA can be resolved with withdrawal instructions and ES can be safely prescribed and administered by Korean medicine doctors. Further studies are needed to determine how to prevent FP IA after taking ES.

• The Journal of Korean Medicine
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• v.26 no.3 s.63
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• pp.249-262
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• 2005

Backgrounds : As obesity prevails as an epidemic. diet programs including low-calorie diets are developed continuously. It is generally believed that a low-calorie diet is commonly followed by resting metabolic rate decrease and ultimate weight regain. Ephedra and Evodia are known to have sympathomimetic and anti-obesity effect. Objectives : This study was a prospective, double-blinded, randomized md placebo-controlled clinical trial to evaluate the effects of Ephedra sinica and Evodia rutaecarpa on resting metabolic rate (RMR), weight, body composition, and short-term safety in obese women on low-calorie diet. Methods : 125 otherwise healthy obese women (body mass Index ${\geq}\;25kg/m^2$) were recruited and randomly assigned to three groups: Ephedra group (n=41), Evodia group (n =45), and placebo group (n=39). Subjects were administered Ephedra extract in capsules (pseudo-ephedrine 31.52mg) or Evodia extract in capsules (evodiamine 6.75mg, rutaecarpine 0.66mg) or placebo capsules as well as participating in a low-calorie diet for 8 weeks, Resting metabolic rate and body composition were measured at baseline,4 and 8 weeks. Basic serum exams were performed to evaluate the short-term safety of the herbs and changes of lipid variables. Results : All three groups showed significant BMI decreases probably due to low-calorie diet. Among them, the Ephedra group manifested most prominent BMI-reducing effect and towered total cholesterol and triglycerides significantly. The RMR was not changed during the 8-week diet in all groups. No significant difference among the groups was found in RMR, either. Stbject with higher RMR than the mean at the baseline showed a tendency to keep their RMR more stable during the diet program. Conclusions : Ephedra with a low-calorie diet was effective in reducing BMI. RMR change was not compensated by herbal medicines. RMR change seemed to be affected rather by constitution and body composition than medicine. Ephedra and Evodia were proven to be safe for sort-term use in herbal form. Especially, Ephedra was effective in lowering total cholesterol and triglycerides during the 8 weeks.

• The Korea Journal of Herbology
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• v.39 no.4
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• pp.1-9
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• 2024

Objective : In this study, the anti-obesity effect of Fragaria orientalis (FO) on high-fat diet-induced obese mice was investigated. Drug treatment methods are widely used as obesity treatment methods, but research using various natural products is being conducted due to safety concerns. This study aims to evaluate the anti-obesity effect of FO extract, a natural product derived from Mongolia. Methods : C57BL/6 mice were used and divided into three groups, normal diet group, high-fat diet group, and high-fat diet with FO oral treatment group at a dose of 300 mg/kg. Extract was orally provided everyday for 6 weeks. Body Weight and food intake were measured every 2 days and blood lipid profiles and liver function in the sacrificed mice were evaluated. In addition, protein expression in hepatic tissue and histomorphological changes in liver and adipose tissue were observed. Results : Body weight, adipose tissue weight and FER were significantly lower in a high-fat diet with FO treatment than fed only high-fat diet. There was a significant difference between the high-fat diet and the FO-treated high-fat diet mice. As a result of analyzing lipid metabolism-related genes in hepatic tissue, all of p-AMPK, p-ACC, PPAR-α, CPT-1, and UCP-1 showed significant increases, and PPAR-γ also decreased significantly compared to the high-fat diet group. Conclusion : Overall, these results indicate that FO is effectual in improving obesity, suggesting that it can be used as a possible material for anti-obesity agents or functional supplements for weight control.