초록

퇴행성 슬관절염에 대한 새뜸 다기관 임상연구 수행
알레르기성 비염에 대한 탐색 임상연구 수행
새로운 전자뜸 Cettum-Delta 개발
기술이전 계약 체결
디자인특허 2건 등록
기술특허 2건 출원중 및 디자인특허 2건 출원중

(출처 : 요약서 3p)

Abstract ▼

Purpose&Contents
The purpose of the study is to assure the effectiveness and safety of Korean traditional medical device using Cettum(electrical moxibustion) modernized from conventional moxibustion for knee osteoarthritis and allergic rhinitis representative of chronic disease.

We intend

Purpose&Contents
The purpose of the study is to assure the effectiveness and safety of Korean traditional medical device using Cettum(electrical moxibustion) modernized from conventional moxibustion for knee osteoarthritis and allergic rhinitis representative of chronic disease.

We intend to contribute development improved moxibustion device satisfied with Draft international standard(IOS) of EM through high quality clinical trials.
Also, based on this, improvement of public health and national competitiveness is expected to increase through industrialization, scientification and globalizaion of technology in terms of Korean medical treatment.

Results
1. Multicenter trials to evaluate effectiveness and safety of EM treatment for KOA Developing study protocol for multicenter trials cooperated with Donnguk University Bundang Oriental Hospital(1st organization), Donnguk University Ilsan Oriental Hospital(3rd organization), Data Management (DM) and Statistics Institute, CRO and related enterprise

Being approved by IRB of Donnguk University Bundang/Ilsan Oriental Hospital
Registration of registry (ClinicalTrials.gov) for study protocol Publication of study protocol : Efficacy and safety of electrical moxibustion for knee osteoarthritis: study protocol for a randomized controlled trial(Kang et al. Trials. 2018. 19:159.)
Launch meeting for performing multicenter clinical trials and preparing standardized guideline
Performing CRO monitoring for high quality study
Completing multicenter trials and approve of completion from IRB
Arrangement of result data from clinical trials completing statistical analysis
Writing result of clinical trials and presentation of ICOM

2. Exploratory trials for evaluating effectiveness and safety of EM for treating AR
Developing study protocol for Exploratory trial cooperated with medical personnel of Korean Medicine Opthalmology, Otolaryngology / Dermatology, Opthalmology, DM and Statistics Institute and related enterprise
Being approved by IRB of Dongguk University Ilsan Oriental Hospital
Registration of registry (ClinicalTrials.gov) for study protocol
Writing study protocol and submitting
Launch meeting for performing clinical trials and starting to educate researchers
Completing exploratory trials and approve of completion from IRB
Arrangement of result data from clnical trials and performing statistical analysis

3. Study for improvement of EM performance
Developing EM device accorded with performance and safety of ISO criteria
Including Under 60℃, temperature deviation less than ± 3℃, time error less than 5%, temperature control system, single-failure condition, safety response function, setting temperature display function
Performing pilot study of relation between temperature and time for low temperature burns
Publish on journal article in Korea : A Study on the Proper Treatment Time of Electronic Moxibustion - Focusing on the Skin Safety - (Korean Journal of Acupuncture Vol.35, No.1, pp.36-40, 2018.)

Completing test device
Detachable battery, triangle design possible to treat with acupuncture at the sametime, sensor function during treatment, function of checking patients' temperature, design possible to combine and alternative to larger moxibustion device Completing the technology transfer agreement and applying item authorization

Expected Contribution
Solving the problem conventional moxibusion had (such as smell, smoke, burns and so on) and developing moxibustion device accorded with ISO
Contributing objetification and systematization of TKM treatment technology by performing high quality of clinical trials
Promoting delepment of TKM treatment device and preparing ground of medical device industry
Contributing to increase market share of national product in alternative field by strengthing competitiveness of improved TKM treatment device
Activating domestic market and contributing to enter foreign market by investigating scientific effectiveness and safety of device already marketable and upgrading

(출처 : SUMMARY 6p)

목차 Contents

• 표지 ... 1
• 제출문 ... 2
• 보고서 요약서 ... 3
• 국문 요약문 ... 4
• SUMMARY ... 6
• CONTENTS ... 8
• 목차 ... 9
• 1. 연구개발과제의 개요 ... 10
• 1-1. 연구개발 목적 ... 11
• 1-2. 연구개발의 필요성 ... 12
• 1-3. 연구개발의 범위 ... 28
• 2. 국내외 기술개발 현황 ... 31
• 3. 연구수행 내용 및 결과 ... 33
• 3-1. 새뜸의 퇴행성 슬관절염의 유효성 및 안전성 평가를 위한 다기관 임상연구 수행 ... 33
• 3-2. 새뜸의 통년성 알레르기 비염에 대한 유효성 및 안전성 평가를 위한 탐색적 임상연구 수행 ... 60
• 3-3. 새뜸 성능 향상에 관한 연구 ... 85
• 4. 목표달성도 및 관련분야 기여도 ... 89
• 4-1. 목표달성도 ... 89
• 4-2. 관련분야 기여도 ... 89
• 5. 연구결과의 활용계획 ... 90
• 6. 연구과정에서 수집한 해외과학기술정보 ... 91
• 7. 연구개발성과의 보안등급 ... 91
• 8. 국가과학기술종합정보시스템에 등록한 연구시설·장비 현황 ... 91
• 9. 연구개발과제 수행에 따른 연구실 등의 안전조치 이행실적 ... 92
• 10. 연구개발과제의 대표적 연구실적 ... 92
• 12. 참고문헌 ... 93
• 별첨4. 실적 증빙자료 ... 95
• 별첨5. 사업성과 요약서 ... 105
• 별첨6. 과제기본정보 서식 ... 106
• 끝페이지 ... 107