만성피로에 대한 공진단과 쌍화탕의 안전성 및 유효성 평가를 위한 무작위배정, 이중눈가림, 위약대조 임상시험 : 임상연구 프로토콜
Randomized, Double-blind, and Placebo-controlled a Clinical Study for Chronic Fatigue via the Analysis of Efficacy and Safety of Gongjin-dan and Ssanghwa-tang : Study Protocol
2
조회
0
다운로드
2
인용
0
참고문헌
키워드
초록
Objectives : The purpose of this study is to confirm the efficacy and safety of Gongjin-dan and Ssanghwatang for chronic fatigue. Methods : A total of 90 people, between 19 and 65 years old, will be recruited to participate in a randomized, double-blind, and placebo-controlled a clinical trial. Participants in the Gongjin-dan group will take one pill of Gongjin-dan along with three packs of placebo oral liquid Ssanghwa-tang per day for 4 weeks. Participants in the Ssanghwa-tang group will take three packages of liquid Ssanghwa-tang and one placebo Gongjindan pill per day for 4 weeks. In the placebo group, participants will take one pill of placebo Gongjin-dan and three packs of placebo liquid Ssanghwa-tang per day, for 4 weeks. Outcomes will be measured at the baseline, 4th week, and 6th week. The primary outcome is the change in the Fatigue Severity Scale (FSS). Secondary outcomes are the change of Multidimensional Fatigue Inventory-20 (MFI-20), Chalder Fatigue Scale (CFQ), Short-Form 36 Health Survey (SF-36), Korean Version of Schedule of Fatigue and Anergy/General Physician (SOFA/GP), Glucose, Lactate, Ammonia, Free Fatty Acid (FAA), d-ROMs&BAP, Selenium, and Cortisol. Results : This trial was approved by the institutional review board of Pusan National University Korean Medicine Hospital (registry number: PNUKHIRB 2021-10-005). Recruitment opened in November 2021 and is supposed to be completed by December 2022. Conclusions : This trial will provide clinical information to determine the efficacy and safety of Gongjindan and Ssanghwa-tang for chronic fatigue.
Abstract
Objectives : The purpose of this study is to confirm the efficacy and safety of Gongjin-dan and Ssanghwatang for chronic fatigue. Methods : A total of 90 people, between 19 and 65 years old, will be recruited to participate in a randomized, double-blind, and placebo-controlled a clinical trial. Participants in the Gongjin-dan group will take one pill of Gongjin-dan along with three packs of placebo oral liquid Ssanghwa-tang per day for 4 weeks. Participants in the Ssanghwa-tang group will take three packages of liquid Ssanghwa-tang and one placebo Gongjindan pill per day for 4 weeks. In the placebo group, participants will take one pill of placebo Gongjin-dan and three packs of placebo liquid Ssanghwa-tang per day, for 4 weeks. Outcomes will be measured at the baseline, 4th week, and 6th week. The primary outcome is the change in the Fatigue Severity Scale (FSS). Secondary outcomes are the change of Multidimensional Fatigue Inventory-20 (MFI-20), Chalder Fatigue Scale (CFQ), Short-Form 36 Health Survey (SF-36), Korean Version of Schedule of Fatigue and Anergy/General Physician (SOFA/GP), Glucose, Lactate, Ammonia, Free Fatty Acid (FAA), d-ROMs&BAP, Selenium, and Cortisol. Results : This trial was approved by the institutional review board of Pusan National University Korean Medicine Hospital (registry number: PNUKHIRB 2021-10-005). Recruitment opened in November 2021 and is supposed to be completed by December 2022. Conclusions : This trial will provide clinical information to determine the efficacy and safety of Gongjindan and Ssanghwa-tang for chronic fatigue.
참고문헌 (43)
- 정규인, "피로와 우울. 불안증 환자에서 Fatigue Severity Scale의 임상적 유용성", 정신신체의학, 9(2), pp.164~173 (2001), 한국정신신체의학회
- Fukuda K, "The chronic fatigue syndrome : A comprehensive approach to its definition and study", Ann Intern Med, 121(12), pp.953~959 (1994)
- Kim Cheol Hwan, "Prevalence of Chronic Fatigue and Chronic Fatigue Syndrome in Korea: Community-Based Primary Care Study", Journal of Korean Medical Science, 20(4), pp.529~534 (2005), 대한의학회
- "Treatment of ME/CFS" (2018)[URL]
- Chen R, "Traditional Chinese medicine for chronic fatigue syndrome", Evid Based Complement Alternat Med, 7(1), pp.3~10 (2010)
- 김지원, "만성피로의 한의임상진료현황에 대한 조사 연구", 동의생리병리학회지, 32(2), pp.126~133 (2018), 한의병리학회[DOI]
- Moon E, "The multi-herbal medicine Gongjin-dan enhances memory and learning tasks via NGF regulation", Neurosci Lett, 466(3), pp.114~119 (2009)
- 박치상, "拱辰丹의 성분 분석 및 抗酸化 작용에 미치는 영향", 대한본초학회지, 22(2), pp.51~63 (2007), 대한본초학회
- Hong SS, "The traditional drug Gongjindan ameliorates", J Ethnopharmacol, 168, pp.268~278 (2015)
- Sunwoo YY, "A pilot study for the neuroprotective effect of Gongjin-dan on transient middle cerebral artery occlusion-induced ischemic rat brain", Evid Based Complement Alternat Med, 2012, pp.682720~ (2012)
- Kim YH, "The effect of Gongjindan on the lipid metabolism in rats fed high fatdiet", J East-West Med, 14(2), pp.61~78 (1989)
- Hwang SM, "The effects of KongJindan(KJD)on the Alzheimer`s disease model induced by CT105", J Orient Neuropsychiatry, 15(2), pp.103~118 (2004)
- 정효창, "공진단이 알츠하이머형 치매 환자에게 미치는 영향", 동의신경정신과학회지, 15(2), pp.141~148 (2004), 대한한방신경정신과학회
- Lee DS, "A effect of Gongchen-dan to anemia", J Kyungwon Univ Korean Med Inst, 7, pp.97~107 (2004)
- Son MJ, "Evaluation of the anti-fatigue effects of a traditional herbal drug, Gongjin-dan, under insufficient sleep conditions : study protocol for a randomised controlled trial", Trials, 17, pp.418~ (2016)
- Nam DJ, "Review about the study of Ssanghwa-tang published in Korea from 2000to 2019", J Haehwa Med, 28(2), pp.12~19 (2019)
- 이준경, "EBM 구축을 위한 쌍화탕의 실험 연구 문헌 분석", 한국한의학연구원논문집, 14(3), pp.41~47 (2008), 한국한의학연구원
- 박지영, "쌍화탕 추출물이 항산화효소 및 항노화관련 효소 활성에 미치는 영향", 대한본초학회지, 27(3), pp.67~74 (2012), 대한본초학회
- 김동선, "폴리페놀 및 항산화 관점에서의 쌍화탕 및 단미혼합쌍화탕의 동등성", 한국한의학연구원논문집, 17(2), pp.169~172 (2011), 한국한의학연구원
- Sohn NW, "Histochemical study for the effect of Ssanghwatang on the glycogen contents in liver and muscles of rats", Kor J Herbology, 9, pp.115~125 (1994)
- Ann BN, "Effect of a Chinese traditional medicine, Ssangwhatang, on the pharmacokinetics of sulfobromophthalein in the rats of hepatic failure induced by carbon tetrachloride", Yakhak Heoeji, 28, pp.207~215 (1984)
- 정다영, "대표적인 補陰之劑의 면역 활성화 비교 연구- 육미지황탕, 자음강화탕, 쌍화탕 -", 대한한의학회지, 31(5), pp.112~123 (2010), 대한한의학회
- Kim IH, "Studies on the antiinflammatory activities of Ssanghwa-tang", Kor J Pharmaco, 12, pp.131~135 (1981)
- Han DS, "Analgesic and anticonvulsionary effects of Ssanghwa-tang", Kor J Phamaco, 14, pp.60~63 (1983)
- Kim YB, "Gugissanghwa-tang water extract on the sexual behavior and serum testosterone concentration in male rats", Kor Soci Pathol, 13, pp.152~157 (1997)
- Ann C, "Study of the effects of Ssangwha-tang on the antifatigue action and blood by repeated administration in mice", J Kyung Hee Kor Med, 4, pp.137~143 (1981)
- Ha TY, "Effect of Ssanghwa-tang and Ssanghwa-tang-mixed-Paedoksan on the recovery of exercise induced fatigue", Kor J Life Sci, 8(4), pp.366~372 (1998)
- Park WG, "Effects of Ssanghwatang on the antifatigue action and brain levels of norepinephrine, serotonin, 5-hydroxyindole-acetic acid and dopamine", J Jeahan Oriental Med Academy, 1(1), pp.130~145 (1995)
- Lee KO, "A study of the effect of recruitment with a dosage of Ssanghwa-tang(雙和湯) after motor performance", KSSS, 8(2), pp.475~484 (1999)
- Park SB, "Human placental extract as a subcutaneous injection is effective in chronic fatigue syndrome : A multi-center, double-blind, randomized, placebo-controlled study", Biol Pharm Bull, 39(5), pp.674~679 (2016)
- Bang H, "Assessment of blinding in clinical trials", Control Clin Trials, 25(2), pp.143~156 (2004)
- 조정효, "만성피로의 체계화된 한의학적 치료법 연구의 필요성", 대한한의학회지, 30(4), pp.28~36 (2009), 대한한의학회
- Sung WS, "Efficacy of Korean red ginseng(Panax ginseng)for middle-aged and moderate level of chronic fatigue patients : A randomized, double-blind, placebo-controlled trial", Complement Ther Med, 48, pp.102246~ (2020)
- Cella M, "Measuring fatigue in clinical and community settings", J Psychosom Res, 69(1), pp.17~22 (2010)
- Brown LF, "Symptom inventory in assessing cancerrelated fatigue", Supportive Care in Cancer, pp.1255~1259 (2011)
- Hadzi-Pavlovic D, "Screening for prolonged fatigue syndromes : validation of the SOFA scale", Soc Psychiatry Psychiatr Epidemiol, 35(10), pp.471~479 (2000)
- 김성수, "운동 후 회복기 스포츠 마사지가 Blood Lactate, LDH and Glucose에 미치는 영향", 아시안뷰티화장품학술지, 8(3), pp.115~124 (2010), 한국피부과학연구원
- Azevedo RA, "Slight power output manipulations around the maximal lactate steady state have a similar impact on fatigue in females and males", J Appl Physiol, 130(6), pp.1879~1892 (2021)
- Wilkinson DJ, "Ammonia metabolism, the brain and fatigue; revisiting the link", Prog Neurobiol, 91(3), pp.200~219 (2010)
- Blomstrand, "Amino acids and central fatigue", Amino Acids, 20(1), pp.25~34 (2001)
- Fukuda S, "A potential biomarker for fatigue : Oxidative stress and anti-oxidative activity", Biol Psychol, 118, pp.88~93 (2016)
- Maria Luiza dos Santos Vieira, "Supplementation with Selenium Can Influence Nausea, Fatigue, Physical, Renal, and Liver Function of Children and Adolescents with Cancer", Journal of Medicinal Food, 18(1), pp.109~117 (2015), 한국식품영양과학회[DOI]
- Powell JH, "Unstimulated cortisol secretory activity in everyday life and its relationship with fatigue and chronic fatigue syndrome : A systematic review and subset meta-analysis", Psychoneuroendocrinology, 38(11), pp.2405~2422 (2013)
