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A clinical study for the effect of ointment contained Takrisodok-Eum on recovering the damaged skin barrier by Atopic dermatitis (탁리소독음(托裏消毒飮) 함유 외용제의 아토피 피부염에 대한 임상적 연구)

  • O, Min-Ji;Yoo, Young-Beup;Lim, Sin-Heuk;Kim, Hee-Taek
    • The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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    • v.24 no.3
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    • pp.84-107
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    • 2011
  • Purposes : The purpose of present study is to detect the effects of ointment contained Takrisodok-Eum on the skin barrier's recovery of the Atopic dermatitis. Methods : A total of 44 patients who visited Semyung Oriental Medical Center from April 27th, 2011 to September 20th, 2011 were included in the study. In this study, the patients were treated with Takrisodok-Eum (experimental group) and positive control group. For 8 weeks of gross examination, hematological examination and instrumental asessment were made before and after the study to examine how well the products for experimental group with those for control group in recovering the damaged skin barriers by Atopic dermatitis. Results : 1. In the primary endpoint, SCORAD Index showed a statistically significant decline in experimental group. 2. In the secondary endpoint index of skin hydration, both the experimental group and the control group showed statistical significance. 3. In the secondary endpoint index of TEWL, the experimental group showed greater statistical significance than the control group. 4. In the secondary endpoint index of skin pH, skin pH showed a statistically significant decline in both the control group and the experimental group within the normal range. 5. In the secondary endpoint index of Total IgE, Eosinophil count, IL-10, IL-13, both the experimental group and the control group showed no statistical significance. 6. To evaluate the safety of the products for the human body, hematological examination and hematological biochemical examination, vital sign check were conducted; both control group and experimental group showed no abnormal level. And There were no severe adverse events during this study. Therefore, it is suggested that the safety of the products, if used for certain period, should be safe for the human body. Conclusions : According to the above experiments, it is suggested that Takrisodok-Eum should be effective for the Atopic dermatitis.

An Investigation about the Present States of Clinical Trial for Traditional Medicine in Korea, China, Taiwan and Japan (한국과 중국, 대만, 일본의 전통약 임상시험 현황에 대한 연구)

  • Lee, Kyun-Goo;Bae, Sun-Hee;Shin, Hyeon-Kyoo
    • Korean Journal of Oriental Medicine
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    • v.12 no.1
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    • pp.13-22
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    • 2006
  • Background and Aims: Herbal drugs and traditional medicines have lately attracted considerable attention by global pharmaceutical corporations because the conventional chemical drugs didn't work well for many chronic diseases or intractable diseases. The government of Korea is also supporting to develop the new drug which is high value added product, and the natural medicine including herbal medicine(or Traditional Korean Medicine) have a significant presence in this field. non-clinical pharmacology/toxicology study and clinical trial are the two major criteria which estimate efficacy and safety for registration of new drugs. All of the pharmaceutical companies producing herbal medicine and the academic and the academic world of Tradition Korean Medicine have the will to develop new herbal drugs, but there are obstacles that they have neither experience nor guideline about clinical trial. Therefore for developing new herbal drugs, it is necessary to research the present conditions and comprehensive systems about clinical trial in Northeast Asian countries China, Taiwan and Japan because they have the common background with Korea in traditional medicine fields. Methods : The present state of clinical trial for herbal medicine in Korea was investigated. And then, those in China, Taiwan, Japan was also investigated. Results and conclusions : There are significant differences among 4 Southeast Asian countries Korea, China, Taiwan and Japan each in present condition, purpose, involved comprehensive system including legislation, and actual operation of clinical trial for traditional medicine.

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