• Title/Summary/Keyword: Herbal medicine safety

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Clinical Trial to Evaluate the Hot Flush Relief Efficacy and Safety of Yiseontang-gami in Climacteric Women with Hot Flushes (갱년기 여성의 안면홍조에 대한 이선탕가미방(二仙湯加味方)의 증상완화 효과 및 안전성 평가를 위한 임상연구)

  • Jung, Su-Kyoung;Kim, Dong-Il
    • The Journal of Korean Obstetrics and Gynecology
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    • v.21 no.3
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    • pp.75-89
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    • 2008
  • Purpose: To evaluate the hot flush relief efficacy of Yiseontang-gami in climacteric women with hot flushes, a vasomotor symptom. Methods: The 20 subjects who signing on the clinical trial written consent by self-will is registered this clinical trial after decided suitable by selection and exception standard, after take a medical experiment and checkup according to clinical trial plan. Registered subject should valuated by settled schedule after take the testing medicine(Yiseontang-gami)during thirty-day. The evaluating indexes of this trial are hot flush VAS, hot flush frequency, hot flush consistence time, sweating VAS, palpitation VAS, sleep disturbance VAS, MRS, MENQOL, PGA. Results: The results were as follows 1. 4 subjects dropped out of the clinical trial and 16 subjects completed it. 2. After Yiseontang-gami treatment, hot flush VAS, hot flush frequent, sweating VAS. Palpitation VAS, sleep disturbance VAS improved significantly. 3. After Yiseontang-gami treatment, hot flush consistence time was not improved significantly. 4. After Yiseontang-gami treatment, blood test value were not different significantly. Conclusion: In this clinical trial we consider that Yiseontang-gami is suitable treatment for the hot flushes and related symptoms.

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A Clinical Case Report on Traditional Korean Medical Treatment Including Hwangryunhaedok-tang Pharmacopuncture for Low Back Pain with Sciatica during Pregnancy (황련해독탕 약침 치료를 병행한 임신 중 좌골신경통을 동반한 요통 환자의 증례보고)

  • Kim, Sun-Kyung;Kang, Su-Jin;Hong, Ka-Kyung;Choi, Chang-Min
    • The Journal of Korean Obstetrics and Gynecology
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    • v.32 no.2
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    • pp.138-147
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    • 2019
  • Objectives: This study was to report clinical effect and safety of Traditional Korean Medical Treatment including Hwangryunhaedok-tang Pharmacopuncture for pregnant woman with low back pain with sciatica. Methods: The patient who suffered from sudden low back pain with sciatica was treated with Hwangryunhaedok-tang Pharmacopuncture, acupuncture, moxibustion, herbal medication and cupping therapy during admission. Visual Analog Score (VAS), Oswestry Disability Index (ODI), McGill pain questionnaire-short form (SF-MPQ) were checked to measure the outcome. Results: After treatment, Visual Analog Score (VAS), Oswestry disability index (ODI), McGill pain questionnaire-short form (SF-MPQ) were considerably improved in this case. Conclusions: The results indicate that Traditional Korean Medical Treatment including Hwangryunhaedok-tang Pharmacopuncture is the effective therapy for low back pain with sciatica during pregnancy.

Repeated Dose 4-Week Oral-Treatment for DRF Toxicity Test of HMC05 in Sprague-Dawley Rats (HMC05의 Sprague-Dawley 흰쥐를 이용한 4주 반복 경구투여 DRF 독성시험)

  • Shin, Heung-Mook
    • The Journal of Korean Medicine
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    • v.30 no.5
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    • pp.102-114
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    • 2009
  • Objectives: HMCO5 is an extract obtained from 8 different herbal mixtures. We undertook a safety evaluation of HMCO5 for a dose range finding (DRF) toxicity test in specific pathogen free (SPF) Sprague-Dawley (SD) male and female rats. Methods: The male and female rats were divided into 4 groups, respectively; G(0), treated with distilled water: G(1), treated with 222 mg/kg HMC05: G(2), treated with 667 mg/kg HMC05, and G(3), treated with 2,000 mg/kg HMC05; HMC05 was administered orally for 4 weeks. The safety evaluation examined clinical signs, mortality, body weight, food consumption, water consumption, ophthalmic findings, urinalysis, hematological values, absolute & relative organ weights, and necropsy findings during the tests. Results: There were no changes in clinical signs, mortality, body weight, food consumption, water consumption, and ophthalmic findings examined during the test periods. In serum biochemical values, triglyceride was increased in male group G(3) and Na$^+$ decreased significantly in male groups G(2), G(3) and G(4). In male group G(4), spleen weight decreased relatively and increases of absolute & relative left ovary weights were found. In addition, an adhesion of liver to diaphragm was found in male group G(2). However, we could not find any dose-interrelationships in these changes. Conclusions: These results indicate that HMC05 extract did not show any toxicity in the DRF toxicity study. Therefore, it suggests that establishment of 1,000, 333 and 111 mg/kg dosages are moderate in a repeated dose 26-week oral toxicity study of HMC05.

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Testing of the Safety and the Effectiveness of Using Samjeong Pharmacopuncture Solution as Eye drops

  • Seo, Hyung-Sik;Lee, Dong-Jin
    • Journal of Pharmacopuncture
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    • v.15 no.1
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    • pp.23-28
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    • 2012
  • Objective: This experimental study was designed to investigate the safety and the effectiveness of Samjeong pharmacopuncture solution (SPS) manufactured by using a the lowtemperature extract on process. Methods: To identify the safety and the effectiveness of using SPS as eye drops, we performed applied eye irritation tests on rabbits and antibacterial tests for Staphylococcus aureus, Staphylococcus epidermidis, Pseudomonas aeruginosa, Aspergillus niger, Fusarium oxysporum, and Candida albicans. The eye irritation test was performed according to the toxicity testing regulation of the Korea Food & Drug Administration (2009. 8. 24, KFDA 2009-116). After SPS had been applied on the left eye of the rabbits, eye irritation in the cornea, iris and conjunctiva was observed on the 1st, 2nd, 3rd, 4th & 7th day. After SPS had been dropped on bacterial species that cause keratitis, the minimum inhibition concentration and the size of the inhibition zone were measured. The anti-bacterial potency was also measured by taking the size of inhibition zone. Results: After SPS had been administered on the left eye of the rabbits, none of nine rabbits were found to show abnormal signs or weight changes. After SPS had been administered on the left eye of the rabbits, no eye irritation in the cornea, iris and conjunctiva was observed on the 1st, 2nd, 3rd, 4th & 7th day. No specific response was detected in MIC for bacterial species Staphylococcus aureus, Staphylococcus epidermidis, Pseudomonas aeruginosa, Aspergillus niger, Fusarium oxysporum, and Candida albicans after SPS had been applied. Conclusions: This study suggests that SPS is a non-toxic and non-irritant medicine that does not cause any of eye irritation in rabbits, but it has no antibacterial effects on bacterial species that are well known to cause keratitis. These results suggest that more research is required on extracts from herbal medicines for treating keratitis.

A Comparative Study on the Traditional Medicine Policies between Korea and China: Focused on the Second Korean Medicine Development Plan and the 12.5 Traditional Chinese Medicine Development Plan (한국과 중국의 전통의학 정책 비교: 제2차 한의약육성발전계획 및 중의약사업발전 12.5규획 중심)

  • Ko, Chang-Ryong;Ku, Nam-Pyong;Seol, Sung-Soo
    • Journal of Korea Technology Innovation Society
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    • v.17 no.2
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    • pp.421-447
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    • 2014
  • Traditional medicine has been integrated into the national health system in many countries such as Korea, China, Taiwan, etc. Korea and China are most representative among them. The purpose of this study is to compare the policies on traditional medicine in Korea and China focusing on where it came from and where it is headed. In this regard, the study suggested the first analysis tool in the world for analyzing the policy of traditional medicine. The results of the study are as follows: First of all, the development process of Korean Medicine (KM) and Traditional Chinese Medicine (TCM) shows the same pattern, that is, both are influenced by its own national policies. Secondly, the difference between the two countries is due to the gap in the development status or the different aspects in national heath system. TCM is more vitalized in health system and has larger category, and stays ahead in globalization compared to KM. TCM covers Chinese medicine, integrative medicine and ethno-medicine. Korea emphasizes the role of KM in the declining birthrate and aging society, and promotes the overseas patient invitation strategy. China, on the other hand, establishes the medical system for emergency medical treatment and preventive treatment of major diseases and promotes overseas expansion of TCM service. In addition, Korea stressed the safety and distribution of herbal medicine, and China emphasizes production technologies. Korea has a strong medical device industry along with the government's fostering policy; however, in China, medical devices are in the R&D stage yet. Even though both countries promotes the drug development from natural products, Korea focuses on developing herbal cosmetics in application industry, but China shows weakness in policies on application industry. China shores up the foundation for culture and theory of traditional medicine, while Korea doesn't have related policy. Korea places emphasis on promoting collaboration with international organizations and medical volunteer programs, whereas China is more interested in mutual cooperation and real trade with other countries.

Effects of Korean Medicine Treatment in Post-acute COVID-19 Syndrome: A Retrospective Case Series of 15 Patients (한방병원에 내원한 급성기 이후 코로나-19 환자 15명에 대한 임상적 특징 및 치료 분석 : 사례군 연구)

  • Park, Jiwon;Hong, Sung-eun;Shin, Jeong-Won;Kim, Kwan-Il;Lee, Beom-Joon;Jung, Hee-Jae
    • The Journal of Internal Korean Medicine
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    • v.43 no.3
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    • pp.396-412
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    • 2022
  • Objective: The aim of this study was to identify the clinical features of post-acute COVID-19 syndrome and the efficacy and safety of Korean medicine treatment. Methods: This study was conducted on 15 patients with post-acute COVID-19 syndrome who visited the outpatient Allergy, Immune, and Respiratory System Department at Kyung Hee University Korean Medicine Hospital from January 10, 2021 to April 10, 2022. We retrospectively analyzed the charts of 15 patients and collected clinical characteristics, Korean medicine treatments, outcome variables (Numeral Rating Scale (NRS), modified Medical Research Council scale (mMRC), Leicester Cough Questionnaire (LCQ), Quality of Life Visual Analog Scale (QOL-VAS), The Post-COVID-19 Functional Status (PCFS)), adverse events, etc. Results: Of the 15 patients, seven (46.7%) were men, and the average age of all patients was 49.7±13 years. The most common symptom was cough (n=9, 60%), and it was followed by dyspnea or increased respiratory effort, fatigue, insomnia, anosmia, etc. The herbal medicine was prescribed for all 15 patients, and Saengmaek-san (n=8, 53.5%) was the most prescribed. Additionally, acupuncture and cupping were performed in four patients (26.7%) each, and electroacupuncture was applied to one patient (6.7%). As a result of Korean medicine treatment, NRS, mMRC, LCQ, QOL-VAS, and PCFS showed improvement, and adverse events were mild. Conclusions: This study presented the clinical features of post-acute COVID-19 syndrome and suggested that Korean medicine treatment may be effective in alleviating related symptoms and enhancing quality of life.

Moxibustion for Knee Osteoarthritis : A Protocol for a Pilot Randomized Controlled Trial (슬관절염에 대한 뜸 치료의 유효성 및 안전성 연구 : 무작위 대조 예비 임상연구 프로토콜)

  • Lee, Seung-Hoon;Kim, Kun-Hyung;Kim, Tae-Hun;Kim, Jung-Eun;Kim, Joo-Hee;Kang, Kyung-Won;Jung, So-Young;Kim, Ae-Ran;Park, Hyo-Ju;Shin, Mi-Suk;Hong, Kwon-Eui;Choi, Sun-Mi
    • Korean Journal of Acupuncture
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    • v.28 no.4
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    • pp.1-15
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    • 2011
  • Objectives : The purpose of this study is to evaluate the feasibility of massive clinical research and to make a basic analysis on the effectiveness and safety of moxibustion treatment on knee osteoarthritis compared to usual care. Methods and Results : This study is a protocol for a pilot randomized controlled trial. Forty participants are assigned to the moxibustion group (n=20) and usual care group (n=20). Participants assigned to the moxibustion group receive moxibustion treatment on the affected knee(s) at six standard acupuncture points (ST36, ST35, ST34, SP9, Ex-LE04 and SP10) three times per week for four weeks (total of 12 sessions). Participants in the usual care group don't receive moxibustion treatment during the study period and follow-up are made on the 5th, 9th and 13th weeks after random allocation. Both groups are allowed to use any kind of treatment, including surgery, conventional medication, physical treatment, acupuncture, herbal medicine, over-the-counter drugs and other active treatments. Education material that explains knee osteoarthritis and current management options and self-exercise is provided for each group. The pain scale of the Korean Western Ontario and McMaster Universities Questionnaire (K-WOMAC) is the primary outcome measurement used in this study. Other subscales of the K-WOMAC, the Short-Form 36 Health Survey (SF-36), Beck Depression Inventory (BDI), Physical Function test, Patient Global Assessment, and Pain Numeric Rating Scale (NRS) are used as outcome variables to evaluate the effectiveness of acupuncture. Safety is assessed at every visit. Conclusions : The result of this trial will provide a basis for the effectiveness and safety of acupuncture treatment for knee osteoarthritis.

The Comparative Study of Immunomodulatory Effect by Glycyrrhiza New Varieties and Official Compendia (감초 신품종 및 약전 수재감초의 면역조절 효과 비교 연구)

  • Kang, Yun-Mi;Kim, Wonnam;Jin, Jong-Sik;Lee, Jong-Hyun;Chang, Jae Ki;Lee, Jeonghoon;An, Hyo-Jin
    • The Korea Journal of Herbology
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    • v.35 no.6
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    • pp.11-19
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    • 2020
  • Objective : The genus Glycyrrhiza has been used in food and traditional herbal medicine. Glycyrrhiza new varieties Wongam and Sinwongam have been developed by Korea Rural Development Administration and investigated to register on Korean Pharmacopoeia of the Ministry of Food and Drug Safety. The aim of this study is to investigate the immunomodulatory effect of Wongam and Sinwongam comparing with listed Glycyrrhiza species (Glycyrrhiza uralensis Fischer and G. glabra Linne) for evaluations about pharmacological effect of Glycyrrhiza new varieties. Methods : We studied the immunomodulatory effect of Wongam and Sinwongam compared with G. uralensis and G. glabra using THP-1 cell in vitro model. The cells were treated with phorbol 12-myristate 13-acetate (PMA) for differentiation and stimulated with lipopolysaccharides (LPS) to induce immune activation. We analyzed and compared the effects Glycyrrhiza new varieties and listed Glycyrrhiza species using nitric oxide (NO) assay, western blot, and reverse transcription-quantitative polymerase chain reaction analysis. 1) Results : Wongam and Sinwongam showed no cytotoxicity in THP-1 cells. Wongam and Sinwongam, and listed Glycyrrhiza species increased NO production, and cyclooxygenase (COX)-2 expression with or without LPS in differentiated THP-1 macrophages. Furthermore, Wongam and Sinwongam and listed Glycyrrhiza species upregulated the mRNA expressions of T helper type 1 (Th 1)-associated cytokines in LPS-stimulated THP-1 macrophages. Conclusion : These results indicated that Wongam and Sinwongam would have effect of enhancing immune response through the increase of NO and COX-2 expression, and activate Th1-associated cytokines. The findings of this study suggest the wide applicability of Glycyrrhiza new varieties.

Convergence Study of Cell Viability and Vascular Relaxtion of Hanbang-tea Prescrpition (한방차 조성물의 세포활성과 혈관이완 효과에 대한 융합적 연구)

  • Park, Sung-Hye;Min, Je-Ho
    • Journal of the Korea Convergence Society
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    • v.8 no.2
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    • pp.291-297
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    • 2017
  • This study was aimed to secure the basis for developing the hangbang-tea may help promote healthy blood vessels by natural herbal ingredients formulated in accordance with the basic principles of oriental medicinal theory. We investigated the vessels contracted by concentrations and safety assessment carried out by the cell viability of Taraxaci Herba, Gardeniae Fructus, Chrysanthemum indicum and Lonicerae Flos composition and concentration. We found cell survival were higher than the control group show a beneficial trend in the growth of normal liver and kidney cells. As a results of this study will be the basis to develop the hangbang-tea differentiated in the future oriental medicine resources. Medicinal resources will be hangbang-tea based on clinical trials utilizing herbal western and oriental medicine convergence principle and vascular relaxation mechanism.

Some Toxic Heavy Metals Transferring Rates to Decoction of Five Most Generally Adopting Herbal Medicinal Prescriptions (다섯 가지 다용한약처방의 전탕 전후 유해 중금속 이행률 조사)

  • Kim, Kee Dong
    • Journal of Society of Preventive Korean Medicine
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    • v.19 no.3
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    • pp.103-113
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    • 2015
  • Objective : Five most generally adopting basic oriental prescriptions (yookmijihwangtang, ojeoksan, sipjeondaebotang, samultang, bojoongikgitang) samples were collected from 10 oriental hospitals nationwide and the transferring ratio to aqueous phase (TRAP) were calculated. Method : The samples are grounded evenly and the decocted at $120^{\circ}C$ for 12 min on hot plate and then filtered. The concentrations of As, Cd, Co, Cr and Pb in before and after decoction were measure by ICP/MS and the TRAPs were calculated. Results : The concentrations of As, Cr and Pb in the ground samples before decoction were all below criteria level, and TRAP values were also very low (<10%). For Cd, although some ground samples before decoction showed relatively high concentration level compare to the criteria level, because of their low TRAP (~3%), the actual concentrations in the decoction were quite low compare the criteria level. The Co's concentrations in the ground samples before decoction were all relatively low level. However, the TRAP of Co was astonishingly high value of around 40% average. Conclusion : The toxic heavy metal concentrations in the decoction were very low compare to the criteria level. The TRAPs are less than <10% except Co. The toxic heavy metals in the prescriptions are mainly remained in the residue and the only very small fraction may transferred to the decoctions. Therefore the toxicity of the oriental herbal medicine about the toxic heavy metal may be overstressed. The Co's TRAP turned out to be quite high value (40% average). Since the criteria level wes not established yet, the safety of decoctions according to Co was not fully confirmed.