• Title/Summary/Keyword: Herbal medicine safety

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Clinical Efficacy and Safety of Gyebutang Granules Combined with Acupuncture for the Treatment of Knee Osteoarthritis: Protocol for a Multicenter, Randomized, Assessor-blinded, 2-armed Parallel, Controlled Trial

  • Lee, Cham-Kyul;Kang, Ha-Ra;Lee, Yeon-Sun;Sung, Won-Suk;Lim, Chi-Yeon;Jung, Chan-Yung;Kim, Eun-Jung;Seo, Byung-Kwan;Baek, Yong-Hyeon;Kim, Kyung-Ho;Lee, Eun-Young
    • Journal of Acupuncture Research
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    • v.37 no.2
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    • pp.102-109
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    • 2020
  • Background: Due to the aging population in Korea, knee osteoarthritis (KOA) has become an increasingly common condition. Many patients with KOA prefer analgesics, herbal medicines, acupuncture, or exercise, rather than arthroscopic surgery or a knee replacement. Gyebutang (GB) granules are a herbal extract widely used to treat KOA in traditional Korean medicine, but there is insufficient evidence of its efficacy and safety. Methods: A multicenter, randomized, assessor-blinded, 2-armed parallel, controlled clinical trial has been designed to investigate the efficacy and safety of GB combined with acupuncture for the treatment of KOA. There will be 100 patients with KOA enrolled in the study from 3 traditional Korean medicine hospitals. The participants will be randomly allocated to an experimental group (GB and acupuncture) or a control group (celecoxib and acupuncture) in a 1:1 ratio. Both groups will receive acupuncture treatment once a week for 6 weeks; one group will receive GB and the other will receive celecoxib for the same duration. Results: The primary outcome will be the change of knee osteoarthritic pain, based on scores on a 100 mm visual analog scale. The secondary outcomes will be scores on a numeric rating scale, the Western Ontario and McMaster Universities osteoarthritis index, patient global assessment, European quality of life 5-dimension 5-level scale, and adverse events. Conclusion: The results of this study will provide evidence of efficacy and safety of GB as a treatment for patients with KOA.

Study on The Regulation on Poisonous Medicinal Herbs (독성 한약재의 법적 규제에 관한 연구)

  • Kweon, Kee-Tae
    • The Korean Society of Law and Medicine
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    • v.11 no.1
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    • pp.271-296
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    • 2010
  • Objective: Poisonous Medicinal herbs can be considered as a risk factor to public health unless they are prescribed by Doctor of traditional Korean medicine. The proper method to manage them should be prepared to prevent risk factors caused by misuse and abuse of the poisonous medicinal herbs and enhance public health. Methods: In this dissertation (paper), the definition, scope, management status, data about pharmacology and toxicity and media release regarding adverse reaction were understood after organizing documents, laws and regulations concerning poisonous medicinal herbs. Also, management methods are suggested by analyzing related examples and regulations in China, Japan and Hong Kong, where the use of herbal medicine is general. Results: Methods for items for poisonous medicinal herbs, safety information management, management based on standardization of traditional processing methodology and reorganization and revision of related laws and regulations are established. Conclusion: Proper laws and regulations are not yet established to manage poisonous medicinal herbs in Korea. In this regard, it is urgent to establish laws and regulations which can apply independently. The purpose of the laws and regulations should be to enhance management of poisonous medicinal herbs and prevent incidence of addiction and death, improving the public health.

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Study of Medicinal Herbs for Applications in Functional Foods -Antifatigue Effects and Safety Evaluation of Leaf and Stem Extract of the Panax Ginseng- (가능성 식품으로의 활용을 위한 한약자원에 관한 연구 -인삼잎과 줄기 혼합 추출액의 항피로 효과 및 안전성 평가-)

  • Han Jong Hyun;Park Sung Hye
    • Journal of Physiology & Pathology in Korean Medicine
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    • v.18 no.4
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    • pp.1134-1139
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    • 2004
  • This study was conducted to investigate the application possibility of leaf and stem extract(LSE) from the mixture of leaf and stem of ginseng radix(Panax Ginseng CA Meyer). This study measured antifatigue effects by rota-rod test and swimming test. Also we examined the cell toxicity in normal liver and kidney cells, and acute toxicity in mice. Dropping times of LSE treated group decreased about 39-83% compared to the control group according to supplementation intake levels. Swimming time in LSE treated group increased compared to the control group at short and long supplementation. Negative effects were not found from the results of the cell toxicity. Also acute toxicity not shown. These results imply that the leaf and stem of ginseng radix could be used as possible food resources and functional food material and feed stuff.

Origanum vulgare and Thymus vulgaris Extract Usability to Improve Silage Hygienic Quality and Reduce Mycotoxin Concentrations

  • Vaiciuliene, Gintare;Bakutis, Bronius;Jovaisiene, Jurgita;Falkauskas, Rimvydas;Gerulis, Gediminas;Baliukoniene, Violeta
    • Journal of Microbiology and Biotechnology
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    • v.30 no.8
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    • pp.1149-1155
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    • 2020
  • Silage is one of the main feed components of ruminants around the world and can make up about 50-80% of the rations of dairy cows during the winter. The aim of this study was to evaluate the usability of oregano (Origanum vulgare L.) and thyme (Thymus vulgaris L.) aqueous and ethanol extracts to improve the hygienic quality of perennial ryegrass, red clover and blue alfalfa silage samples and estimate their effect on mycotoxins concentrations. Under laboratory conditions, 63 silage samples (21 perennial ryegrass, 21 blue alfalfa, 21 red clover) were fermented with inserted aqueous and ethanol extracts of oregano and thyme and two commercial inoculants with mesophilic lactic acid bacteria. After 96 days of fermentation, in silage samples were established fermentation parameters, microbiological status and mycotoxins concentrations. It was determined that the best results for achieving hygienic quality of perennial ryegrass and red clover silage samples was by insertion of aqueous and ethanol extracts of oregano and thyme. In blue alfalfa samples, the best results of silage hygienic indicators were determined by inserting aqueous and ethanol extracts of oregano. Aflatoxin B1 (AFB1), deoxynivalenol (DON), zearalenone (ZEA) and T-2 toxin concentrations in perennial ryegrass, red clover and blue alfalfa silage samples were best reduced by inserting aqueous and ethanol extracts of oregano and thyme. The present study shows that these extracts can be used to improve silage hygienic quality, reduce mycotoxins concentrations and thus ensure the wellness of cattle.

Effect of Salvia plebeia Extract on Patients with Solid Cancer: A Preliminary Clinical Trial Protocol (배암차즈기의 투여가 고형암환자에 미치는 영향을 평가하기 위한 선행적 인체적용시험)

  • Boram, Lee;Sookjin, Pyo;Ae-Ran, Kim;Eunbin, Kwag;Jang-Gi, Choi;Hwaseung, Yoo;Hwan-Suck, Chung;Jongkwan, Jo
    • Herbal Formula Science
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    • v.30 no.4
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    • pp.241-248
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    • 2022
  • Objective : The purpose of this trial is to observe the preliminary effects of Salvia plebeia (SP) extract on quality of life in patients with solid cancer. Methods : This is a prospective, open-label, single-arm, and single-dose clinical trial. Twenty participants who have been diagnosed with solid cancer between the ages of 20 and 65 will be included. All participants will be administered SP granules for 12 weeks. Data will be collected at 4, 8, and 12 weeks after enrollment. The primary outcome is quality of life, using the Korean version of the Functional Assessment Cancer Therapy-General questionnaire. Secondary outcomes include tumor markers in blood tests for each cancer type, soluble programmed death-ligand 1, the percentage of natural killer cells among lymphocytes, ratio of T-helper and T-suppressor cells, ratio of total T, T-helper, T-suppressor, and B cells in lymphocytes, level of C-reactive protein, and tumor size via radiology examination. Safety will be assessed by clinical laboratory tests and monitoring of adverse events. Discussion : This study aims to observe the effects of an oral administration of SP preparations in patients with solid cancer on changes in quality of life and an improvement in immune function. It is expected to provide objective evidence of the effect and safety of SP for patients with solid cancer. Trial registration: KCT0007315 (Clinical Research Information Service)

A Study on Recognition Level of the People on Oriental Medical Services and the Need for its Improvement (한방의료서비스에 대한 인식도 및 개선요구도)

  • Yoo Wang-Keun
    • Journal of Society of Preventive Korean Medicine
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    • v.7 no.2
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    • pp.45-64
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    • 2003
  • This study was conducted to examine the recognition level of the people on oriental medical Services and the need for it's improvement. Data were collected from 1174 residents in Daegu metropolitan city and Gyungbuk province. According to the satisfaction level with each items of oriental medical services, the respondents had positive views on efficacy, kindness, and side-effects. They, however, had negative view on the cost of oriental medical services. In regarding to the priority of improvement of oriental medical system, 'expansion of insurance benefit package' ranked first. Followed by 'safety of herbal medicine(heavy metal/pesticides)', 'improvement of scientific methods and diagnostic technique' etc. For the further development of oriental medical services in the consumer - focused and evidenced-based health care environment, much attention to implement relevant health policy reflecting user's need positively should be made.

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Single Intramuscular-dose Toxicity of Water soluble Carthmi-Flos herbal acupuncture (WCF) in Sprague-Dawley Rats

  • Lee, Hyung-Geol;Kim, Sungchul;Jung, Da-Jung;Choi, Yoo-Min;Sin, Min-Seop;Choi, Seok-Woo;Song, Beom-Yong;Kim, Jong-Uk;Hong, Seung-Won;Yook, Tae-Han
    • Journal of Pharmacopuncture
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    • v.17 no.1
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    • pp.27-34
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    • 2014
  • Objectives: This experiment was conducted to examine the toxicity of Water soluble Carthmi-Flos herbal acupuncture (WCF) by administering a single intramuscular dose of WCF in 6-week-old, male and female Sprague-Dawley rats and to find the lethality dose for WCF. Methods: The experiment was conducted at Biotoxtech according to Good Laboratory Practices under a request by the Korean Pharmacopuncture Institute. This experiment was performed based on the testing standards of "Toxicity Test Standards for Drugs" by the Ministry of Food and Drug Safety. Subjects were divided into 4 groups: 1 control group in which normal saline was administered and 3 test groups in which 0.1, 0.5 or 1.0 mL of WCF was administered; a single intramuscular dose was injected into 5 males and 5 females in each group. General symptoms and body weights were observed/measured for 14 days after injection. At the end of the observation period, hematological and clinical chemistry tests were performed, followed by necropsy and histopathological examinations of the injected sections. Results: No mortalities were observed in any group. Also, symptoms, body weight, hematology, clinical chemistry and necropsy were not affected. However, histopathological examination of the injected part in one female in the 1.0-mL group showed infiltration of mononuclear cells and a multi-nucleated giant cell around eosinophilic material. Conclusion: Administration of single intramuscular doses of WCF in 3 groups of rats showed that the approximate lethal dose of WCF for all rats was in excess of 1.0 mL, as no mortalities were observed for injections up to and including 1.0 mL.