보고서 정보
주관연구기관 |
세명대학교 산학협력단 |
보고서유형 | 최종보고서 |
발행국가 | 대한민국 |
언어 |
한국어
|
발행년월 | 2010-07 |
과제시작연도 |
2009 |
주관부처 |
보건복지가족부 Ministry for Health, Welfare and Family Affairs |
등록번호 |
TRKO201100006570 |
과제고유번호 |
1355060281 |
사업명 |
한의약선도기술개발(구:한방치료기술연구개발) |
DB 구축일자 |
2013-04-18
|
키워드 |
갱년기.폐경기.갱녀기증후군.가미소요산.임상시험.Perimenopause.Menopause.Climacteric syndrom.Gamisoyousan.Clinical trial.
|
DOI |
https://doi.org/10.23000/TRKO201100006570 |
초록
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실험결과 피험자 120명에 대한 결과에서 가미소용산 보험엑기스를 복용한 군과 위약을 복용한 군간에 Kuppermann index, MENQOL, MRS, 안면홍조 점수, 안면홍조 VAS 발한정조 VAS에서 통계적으로 유의한 차이가 없었다. 즉 가미소요산 복용군과 위약복용군 모두에서 약물복용전과 복용후에 갱년기증상의 감소가 있었기 때문에 두군간의 유의한 통계적 차이는 찾을 수 없었다. 그러나 항온항습실에서 객관적인 측정지표로 mexameter, thermometer, corneometer, LDPI와 같은 화장품효능평가시 피부측정기기
실험결과 피험자 120명에 대한 결과에서 가미소용산 보험엑기스를 복용한 군과 위약을 복용한 군간에 Kuppermann index, MENQOL, MRS, 안면홍조 점수, 안면홍조 VAS 발한정조 VAS에서 통계적으로 유의한 차이가 없었다. 즉 가미소요산 복용군과 위약복용군 모두에서 약물복용전과 복용후에 갱년기증상의 감소가 있었기 때문에 두군간의 유의한 통계적 차이는 찾을 수 없었다. 그러나 항온항습실에서 객관적인 측정지표로 mexameter, thermometer, corneometer, LDPI와 같은 화장품효능평가시 피부측정기기로 국제적으로 공인되어 사용되어온 기기를 이용하여 안면홍조정도를 측정한 결과 위약복용군에서는 약물 복용전후에 증상의 유의한 변화가 없었지만 가미소요산복용군 자체만 보았을 경우에는 통계적으로 유의한 증상의 감소가 있는것으로 측정되어 실제적으로 가미소요산복용이 안면홍조의 감소에 유효할 수 있을 것으로 기대할 수 있을 것이다.
Abstract
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In oriental medicine, there is no prescription for menopausal disorders covered by health insurance until now. Menopause disorders is major symptoms of postmenopausal women, but in oriental medicine have not consider it important. As improvement of living standards and life expectancy, prolonged lif
In oriental medicine, there is no prescription for menopausal disorders covered by health insurance until now. Menopause disorders is major symptoms of postmenopausal women, but in oriental medicine have not consider it important. As improvement of living standards and life expectancy, prolonged life time of postmenopausal was also an important part of life. Drug that time, menopausal symptoms is an main cause for reduce quality of life. Although various treatments had been applied for a symptom, those had insufficient effect or side effect. For this reason, many researchers try to develop drugs or treatments which has outstanding effect but no harmful side effect. Oriental medicine also be interested in menopausal disorders have been using mjltiple prescriptions. Among them, common used in clinical practice is Gamisoyosan. Gamisoyosan is typical prescription to relieve the liver qi stagnation. Therefore it'll be effective for menopausal symptoms such as facial flushing, sweating, nervousness, insomnia. But it is very sorry that Gamisoyosan extract dose not receive the insurance coverage when using for menopausal disorder. So I am looking for subjects to demonstrate the effectiveeness of the Gamisoyosan. And double-blind placebo-controlled clinical trial was carried out. Subjects were aged between 45 and 60 years old women, and their facial flusing score was 10 points or more. They have irregular menstruation more than 3 months or postmenopausal amenorrhea last more 6 month. During the eight weeks the subjects were taken a Gamisoyosan extract or placebo 3 timens per day. Before and after the experiment, Blood test were conducted for its efficacy and safety. To get objective results, 21 subject were selected from each group and then facial flushing degree was measured by mexameter, thermometer, corneometer, LDP(Laser Doppler Perfusion Imaging) in the constant temperature and humidity room before and after drugs. This method shows differences between subjective feelings fo the subjects about the facial flusihing and objective degree about that. We found that objectiv measurement methods is very important factor in this clinical trial. The results for 120 people, There was no statistically significant difference between Gamisoyosan extract taken group and placebo group about Kuppermann index, MENQOL, MRS, facial flushing score, facial flushing VAS(Visual Analogue Scale), sweating VAS. In othe words all gorups shows statistcally significant recudtion of symptoms after medication. However objective data from constant temperature and humidity room measurements was different. In placebo group, there was no statistically significant differentce about their symptoms after taken drugs. But in Gamisoyosan extract taken group, most of the i dicators decrease in statistical significance after drugs. This result tells us Gamisoyosan is sure cure for facial flushing. Anothe rimportant thing about result of this study is that indicators we have been used so far such as Kuppermann index, MENQOL, MRS or VAS represent only a patient's subjective opinion. There there can be differences between actual. Condidering these points, this clinical trial performed by using the internationally recognized unit in the constant temperature and humidity room. On the bases of this measurement this sturdy can obtai the more meaningful
목차 Contents
- 1. 겉표지 ... 1
- 2. 제출문 ... 2
- 3. 보고서 요약서 ... 3
- 4. 요약문 (한글) ... 5
- 5. 요약문 (영문) ... 7
- 6. 연구 성과 실적 및 향후 계획 ... 8
- 7. 참여연구원 현황표 ... 13
- I. 총괄연구과제 연구결과 ... 14
- 1. 연구개발과제의 배경 및 필요성 ... 15
- 2. 국내외 기술개발 현황 ... 21
- 3. 연구개발과제의 추진체계 ... 24
- 4. 연구개발수행 내용 및 결과 ... 27
- 5. 목표달성도 및 관련분야 기여도 ... 29
- 6. 향후 연구성과 추진 계획(※해당되는 경우만 작성) ... 31
- 7. 연구개발결과의 파급효과 ... 31
- 8. 연구개발결과의 활용계획 ... 33
- 9. 연구개발과정에서 수집한 해외과학기술정보 ... 33
- 10. 참고문헌 ... 34
- II. 첨부서류 ... 37
- 실적증빙자료 및 첨부서류 목차 ... 38
- 1. 자체평가의견서 ... 40
- 2. 실적 증빙자료 ... 40
- 3. 기타 첨부서류 ... 40
- 끝페이지 ... 40
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