• Title/Summary/Keyword: Herbal medicine safety

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Review on Clinical Studies on Korean medicine Treatment for Trigeminal Neuralgia (삼차신경통의 한의학적 치료에 대한 국내 임상 연구 고찰)

  • Cha, Hyun Ji;Lee, Ye Ji;Kim, Hyo Bin;Kim, Beom Seok;Sung, Ki Jung;Lee, Young Rok;Choi, Kang Min;Kim, Jin Youp;Jeon, Ju Hyun;Kim, Eun Seok;Kim, Young Il
    • Journal of Haehwa Medicine
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    • v.29 no.2
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    • pp.12-21
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    • 2020
  • Objectives : The aim of this study is to review clinical studies on trigeminal neuralgia treatment through Korean Medicine. Methods : We used search engines such as KISS, RISS, KOREAMED and NDSL. We limited cases as idiopathic trigeminal neuralgia without comorbidities. We excluded dissertation. We considered papers published after year 2000. Results : Fourteen studies were searched for this study. Various treatments such as acupuncture therapy, herbal medicine, moxibustion therapy, manipulation, pharmocopuncture, vomiting therapy were practiced for trigeminal neuralgia. Conclusions : All study were case report and evidence level of the searched studies was not high. They reported meaningful improvement through Korean Medicine treatment and these studies implied effectiveness and safety of Korean Medicine for Trigeminal neuralgia.

Characteristics of Clinical Trials in Korea for Atopic Dermatitis - Focus on ClinicalTrials.gov Registered Clinical Trials - (식약처 승인 아토피 피부염 의약품 국내 임상 시험의 특성 - ClinicalTrials.gov 등록 임상시험을 중심으로-)

  • Hwang, Mi-Lee;Ahn, Jae-Hyun;Jea, Ha-Kyung;Kim, Soo-Young;Jung, Hyun-A
    • The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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    • v.32 no.2
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    • pp.68-93
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    • 2019
  • Objective : This study summarized the characteristics of clinical trials for atopic dermatitis medicines approved by the Ministry of Food and Drug Safety(MFDS). This study may be a reference for the design of clinical trials of atopic dermatitis herbal medicine treatment which may be carried out later. Method : The characteristics of the clinical trial were analyzed for clinical trials registered with ClinicalTrials.gov, CRIS, and the Korea Health Industry Development Institute among the clinical trial approval statuses posted on the website of the MFDS. Result : 1. Clinical trial drugs were developed in various formulations such as oral medicines, injections, dermatologic agents, and similar proportions. Relatively little clinical trials were found for herbal medicine. 2. In the control evaluation test, most of the treatments for the control group were performed with placebo using Vehicle. 3. In most clinical trials, one intervention group was in the form of a parallel assignment with only one treatment. 4. The age of the subjects was 11 out of 28 studies including minors, and clinical trials targeting minors were also found to be significant. 5. In the case of atopic dermatitis, the cases of subacute chronic or atopic dermatitis more than 6 months or more than 1 year were often used. 6. Most clinical trials were divided into mild to moderate atopic dermatitis or moderate to severe atopic dermatitis. The SCORAD index, EASI, IGA, BSA, and NRS were used as the evaluation criteria. 7. Regulations for the drugs used prior to the trial period for the treatment of atopic dermatitis vary somewhat from one clinical trial to another. 8. IGA was used most often as a primary efficacy tool, and SCORAD index, EASI, and NRS were also used.

Analysis of the Results of the 2022 Gyeonggi-do Korean Medicine Infertility Support Project (2022년도 경기도 한의약 난임지원사업 결과 분석 연구)

  • Hye-Sung Lee;Hyo-Jung Jung;Su-Ji Choi;Dong-Il Kim
    • The Journal of Korean Obstetrics and Gynecology
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    • v.36 no.4
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    • pp.78-95
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    • 2023
  • Objectives: This study aims to analyze the results of the 2022 Gyeonggi-do Oriental Medicine Fertility Treatment Support Project, review the outcomes and satisfaction of Oriental Medicine fertility support initiatives, and propose progressive fertility treatment support strategies by comparing them with the results of the past three years. Methods: Total of 242 women and 205 spouses participated in the Korean Medicine fertility treatment support project, which encompassed herbal medicine, acupuncture, and counseling treatments over a 3-month period, followed by a 3-month post-treatment follow-up. Data pertaining to patients' general, demographic, and fertility-related characteristics were collected before treatment initiation. During treatment, information regarding the treatments administered by Korean medical doctors was recorded, along with post-treatment outcomes and satisfaction levels. Safety assessments included pre- and post-treatment blood tests and monitoring for adverse events. Results: Among the 242 female subjects, 209 successfully completed the treatment program. Of these, 35 (16.7%) achieved pregnancy, with 30 (15%) attaining pregnancy through herbal monotherapy. Out of the 35 pregnancies, 17 were maintained, while 10 resulted in miscarriage. Notably, 83.8% of patients expressed satisfaction with the treatment outcomes. An analysis spanning three years revealed a continuous increase in the average age of patients, surpassing 38 years in 2022, a critical point in fertility decline age. Additionally, there was a notable rise in the prevalence of patients with a history of gynecological issues, advanced spouse age, and semen abnormalities, which is assumed to have contributed to the decrease in the pregnancy success rate. Conclusions: This study compares the clinical results of the 2022 Gyeonggi-do Korean Medicine Fertility Treatment Support Project with those of the past three years. Based on these findings, recommendations are made to enhance the project, including stricter age criteria for patient selection, enhanced specialized treatment tools for medical doctors, and combining Korean Medicine treatment and medical assisted reproductive technologies, all aimed at increasing pregnancy success rates. These results provide a foundation for the development of fertility support projects and related policies.

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 증상 완화 효과 및 안전성 평가를 위한 임상연구)

  • Jung, Su-Kyoung;Kim, Dong-Il
    • Journal of Oriental Medical Thermology
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    • v.7 no.1
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    • pp.1-13
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    • 2009
  • 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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Medicinal plants used in the management of diabetes by traditional healers of Narok County, Kenya

  • Kamau, Loice Njeri;Mbaabu, Peter Mathiu;Karuri, Peter Gathumbi;Mbaria, James Mucunu;Kiama, Stephen Gitahi
    • CELLMED
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    • v.7 no.2
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    • pp.10.1-10.10
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    • 2017
  • The Maasai community from Kenya is highly esteemed for their strong adherence to traditional cultures and ethno medicine. This is attributed to their age-old traditional mechanisms of passing down knowledge to the younger generation. Adoption to new socio-economic lifestyle and urbanization has been associated with development of diabetes, which has been reported among some indigenous pastoral communities in Kenya. Documentation of traditional methods of treatment and management of diabetes by the Maasai has not yet been reported, yet it is noteworthy. Thirty traditional healers from Narok County were purposively selected and interviewed about traditional knowledge of antidiabetic medicinal plants, parts used, preparation dosage and administration. A total of 14 antidiabetic plant species distributed within 13 genera and 12 families were identified and documented as herbal medicine used in the management of diabetes. The most highly cited plant species was Dovyalis abyssinica (20%), the plant family Flacourtiaceae and Rhamnaceae (2 plant species each) recorded the highest number of plant species while the most frequently used plant part was the roots (46%). Literature review revealed that some of the cited plants have known phytochemicals with antidiabetic activity; the study recommends further scientific investigation to validate their efficacy and safety.

One Case of Drug-Induced Liver Injury Treated with Saenggangeonbi-tang (생간건비탕(生肝健脾湯)을 이용한 급성 약인성 간손상 치험 1례)

  • Jeong, Tae-Young;Choi, Hong-Sik
    • The Journal of Internal Korean Medicine
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    • v.25 no.4
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    • pp.207-211
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    • 2004
  • Recently a case of liver injury from ingestion of Taeyeumjowi-tang containing Ma-huang(Ephedra sinica stapf) arose. The patient, a 30 year-old woman, was diagnosed with asthenia and anorexia after 6 weeks of ingesting Taeyeumjowi-tang containing Ma-huang(Ephedra sinica stapf) as a treatment for her obesity. Tests showed elevated levels of serum transaminase(ALT 903 IU/L, AST 716 IU/L), alkaline phosphatase (229 IU/L), total bilirubin (1.4 mg/dl). Other possible causes of liver injury were excluded by laboratory test and medical history, so the liver injury was taken to be drug-induced. Saenggangeonbi-tang was administered. After 2 weeks of treatment with this medication, the clinical symptoms and liver function improved. This case is reported with a call for further accumulation of objective data on drug-induced liver injury, and to bring more attention to the relative levels of safety and toxicity of herbal medicines.

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Clinical trial to evaluate the efficacy and safety of Tongxinluo in high risk group of cardiovascular diseases (심혈관질환 고위험군에 대한 통심락(通心絡)의 유효성 및 안전성 평가를 위한 임상시험)

  • Park, Seong Uk;Jung, Woo Sang;Moon, Sang Kwan;Go, Chang Nam;Cho, Ki Ho;Kim, Young Suk;Bae, Hyung Sup
    • The Journal of the Society of Stroke on Korean Medicine
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    • v.6 no.1
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    • pp.25-32
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    • 2005
  • Background and purpose: Arterial stiffness is an important, independent determinant of cardiovascular risk. Pulse wave velocity (PWV) has been used as a valuable index of arterial stiffness and as a surrogate marker for atherosclerosis. The Framingham risk score was developed using categorized risk factors to predict the 10 year absolute risk of developing coronary heart disease (CHD). This algorithm is established using recommended guidelines for blood pressure, total cholesterol, and high density lipoprotein cholesterol in addition to age, smoking history and history of diabetes. Tongxinluo(TXL) has been shown to have anti hyperlipidemic activity and anti atherogenic effects. To determine its efficacy and safety, we examined whether TXL improves PWV, ABI, Framingham score, blood pressure, and lipid profile in high risk group of cardiovascular diseases. Subjects and methods: 49 subjects with the high risk of cardiovascular diseases were recruited. Subjects were administered TXL with the dose of 1110mg three times a day for 8 weeks. baPWV, ABI, Framingham risk score, Blood pressure and serum lipid profile were assessed at baseline and after 4 and 8weeks. Results: Total cholesterol, LDL cholesterol, triglyceride, total lipid and phospolipid significantly decreased after 4 weeks of medication. Total cholesterol, total lipid and phospolipid significantly decreased after 8 weeks of medication. There were no significant changes in Framingham risk scores, ABI, PWV and blood pressure. On safety assessment, there were no adverse effects, hepatic or renal toxicity. Conclusion: We suggest that TXL is a safe and useful herbal medicine for hyperlipidemia and as for anti-atherognic effects, further research would be necessary.

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Preliminary Study on Development of Korean Medicine Clinical Practice Guideline for Esophageal Cancer (식도암 한의 임상진료지침 개발 예비 연구)

  • Gwak, Si-Ra;Cui, Zhenyang;Joo, Jong-Cheon;Yoo, Hwa-Seung;Park, Soo-Jung
    • Journal of Korean Traditional Oncology
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    • v.22 no.1
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    • pp.37-48
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    • 2017
  • Objectives: The purpose of this study was to suggest the direction for the development of a clinical practice guideline (CPG) for esophageal cancer (EC). Methods: We collected and analyzed CPGs and related data about esophageal cancer by searching the database of domestic and foreign articles. Results: There were little contents or proposals related to Korean Medicine (KM) or Traditional Chinese Medicine (TCM), those related to KM or TCM can be found only in "Guidelines of Diagnosis and Therapy in Oncology with Traditional Chinese Medicine (惡性腫瘤中醫診療指南)". They were symptom factors, syndrome differentiation (SD) and 'treatment process of esophageal cancer by combination of western medicine and Korean medicine'. Conclusions: The topics of the development Korean medicine CPG for EC are (1) the method and procedure about combination of western medicine and Korean medicine (2) the process of SD and diagnosis (3) safety and efficacy of the herbal medicine and preparation (4) availability and timing of the tools related to KM or TCM like acupuncture, moxibustion, massage, etc.

Efficacy and safety of HT008 and glucosamine sulfate in the treatment of knee osteoarthritis : a randomized double-blind trial (『퇴행성 관절염에 대한 HT008과 글루코사민의 유효성 및 안전성을 비교평가하기 위한 무작위 배정, 이중맹검 임상연구)

  • Park, Sangwoug;Kim, Young-Sik;Lee, Donghun;Kwon, Yongbeom;Park, Juyeon;Lee, Soh-Young;Nam, Dong Woo;Lee, Jae Dong;Kim, Hocheol
    • The Korea Journal of Herbology
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    • v.29 no.4
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    • pp.45-52
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    • 2014
  • Objectives : The purpose of this study was to evaluate the efficacy of HT008 on pain relief and functional improvement in participants with mild knee osteoarthritis (OA) in comparison with that of glucosamine sulfate. Methods : This randomized double-blind trial was conducted at Kyung Hee University Medical Center in Seoul where participants with knee pain for more than 6 months and degenerative osteoarthritis were enrolled. The 100 participants were received either HT008 or glucosamine sulfate 750 mg twice daily for 8 weeks and evaluated at baseline, 4 and 8 weeks after the treatment. We primarily evaluated the differences between two groups with respect to changes in the visual analogue score (VAS) for pain, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score from baseline to week 8. Secondarily the difference between and within two groups with respect to changes in WOMAC stiffness and physical function score, and Lequesne Functional Severity Index (LFI) were also evaluated. Results : At week 8, treatment with HT008 resulted in a significant reduction of the VAS for pain and WOMAC pain scores compared to the glucosamine sulfate (both p=0.003). Patients receiving HT008 experienced statistically significantly greater improvements in WOMAC physical function scores and LFI (p = 0.014 and p=0.016, respectively) than glucosamine sulfate-treated group. The within-group change in WOMAC physical function and stiffness, and LFI during the 8-week intervention revealed significant improvements in HT008-treated group. Conclusions : HT008 treatment allows significant pain reduction and functional improvement compared with glucosamine sulfate. These data confirm HT008 as an effective and safe symptomatic drug for knee OA.

A Case Report of an Epigastralgia Patient using Korean Medicine with Crotonis Fructus Purgation Therapy (파두 공법을 병용한 한방치료로 호전된 위완통 증례보고)

  • Lee, Da-eun;Kim, Dong-hyeon;Noh, Ji-won;Yoo, Jeong-hwa;Ahn, Se-young;Lee, Byung-cheol;Ahn, Young-min
    • The Journal of Internal Korean Medicine
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    • v.39 no.6
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    • pp.1296-1305
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    • 2018
  • A patient with an epigastralgia was treated with Korean medicine for the short-term period of five days under admission care. In this case report, we discuss the efficacy and safety of short-term treatment using Korean medicine methods on a patient with an epigastralgia by evaluating a numerical rating scale, agastrointestinal symptom questionnaire, clinical features, and blood tests. The complex methods comprise purgation therapy using Crotonis Fructus, Korean herbal medication, acupuncture and moxibustion. Throughout the purgation therapy with Crotonis Fructus, the patient reported improvement in both her pain score and dyspepsia index. This case showed that Korean medicine acted not only fast, but also effective for treating epigastralgia patients diagnosed with functional dyspepsia.