The Efficacy and Safety of Chinese Medicine Fufang Zhenzhu Tiaozhi Capsule (FTZ) in the Treatment of Diabetic Coronary Heart Disease: Study Protocol for Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial

Lexun Wang,1 Lei Xiang,1,2 Shenghua Piao,1 Xiao Gong,3 Wanxing Zhou,4 Weixun Feng,5 Huilin Li,6 Leyu Li,7 Aisheng Wei,8 Qing Zhu,1 Xianglu Rong,1 Jiao Guo1,2 1Guangdong Metabolic Diseases Research Center of Integrated Chinese and Western Medicine; Key Laboratory of Glucolipid Metabolic Disorder, Min...

Descripción completa

Guardado en:

Detalles Bibliográficos
Autores principales:	Wang L, Xiang L, Piao S, Gong X, Zhou W, Feng W, Li H, Li L, Wei A, Zhu Q, Rong X, Guo J
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2021
Materias:	type 2 diabetes mellitus traditional chinese medicine clinical study Specialties of internal medicine RC581-951
Acceso en línea:	https://doaj.org/article/8968254a9d054c1693302c826cd381c9
Etiquetas:	Agregar Etiqueta Sin Etiquetas, Sea el primero en etiquetar este registro!

id	oai:doaj.org-article:8968254a9d054c1693302c826cd381c9
record_format	dspace
institution	DOAJ
collection	DOAJ
language	EN
topic	type 2 diabetes mellitus traditional chinese medicine clinical study Specialties of internal medicine RC581-951
spellingShingle	type 2 diabetes mellitus traditional chinese medicine clinical study Specialties of internal medicine RC581-951 Wang L Xiang L Piao S Gong X Zhou W Feng W Li H Li L Wei A Zhu Q Rong X Guo J The Efficacy and Safety of Chinese Medicine Fufang Zhenzhu Tiaozhi Capsule (FTZ) in the Treatment of Diabetic Coronary Heart Disease: Study Protocol for Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial
description	Lexun Wang,1 Lei Xiang,1,2 Shenghua Piao,1 Xiao Gong,3 Wanxing Zhou,4 Weixun Feng,5 Huilin Li,6 Leyu Li,7 Aisheng Wei,8 Qing Zhu,1 Xianglu Rong,1 Jiao Guo1,2 1Guangdong Metabolic Diseases Research Center of Integrated Chinese and Western Medicine; Key Laboratory of Glucolipid Metabolic Disorder, Ministry of Education of China; Institute of Chinese Medicine, Guangdong Pharmaceutical University; Guangdong TCM Key Laboratory for Metabolic Diseases, Guangzhou, People’s Republic of China; 2The First Affiliated Hospital of Guangdong Pharmaceutical University, Guangzhou, People’s Republic of China; 3School of Public Health, Guangdong Pharmaceutical University, Guangzhou, People’s Republic of China; 4Department of Internal Cardiology, The First Affiliated Hospital of Guangdong Pharmaceutical University, Guangzhou, People’s Republic of China; 5Famous Doctor’s Studio, Qingyuan Hospital of Traditional Chinese Medicine, Qingyuan, People’s Republic of China; 6Department of Endocrinology, Shenzhen Traditional Chinese Medicine Hospital, The Fourth Clinical Medical College of Guangzhou University of Chinese Medicine, Shenzhen, People’s Republic of China; 7Department of Endocrinology, Zhongshan Hospital of Traditional Chinese Medicine, Zhongshan, People’s Republic of China; 8Department of Endocrinology, Foshan Hospital of Traditional Chinese Medicine, Foshan, People’s Republic of ChinaCorrespondence: Jiao GuoGuangdong Metabolic Diseases Research Center of Integrated Chinese and Western Medicine; Key Laboratory of Glucolipid Metabolic Disorder, Ministry of Education of China; Institute of Chinese Medicine, Guangdong Pharmaceutical University; Guangdong TCM Key Laboratory for Metabolic Diseases, Guangzhou, People’s Republic of ChinaTel +86-02-39352818Fax +86-02-39352607Email gyguoyz@163.comBackground: Diabetic coronary heart disease (DCHD), the main macrovascular complication of type 2 diabetes mellitus (T2DM), is greatly harmful to T2DM patients. Traditional Chinese medicine (TCM) is an alternative and effective therapy to delay the development of macrovascular diseases, but the existing evidence of its efﬁcacy and safety is insufﬁcient. The aim of this multicenter, randomized, double-blind, placebo-controlled trial is to evaluate the efﬁcacy and safety of Chinese Medicine Fufang Zhenzhu Tiaozhi capsule (FTZ) in treating DCHD.Patients and Methods: This study includes a 2-week run-in, 52-week treatment, and 52-week post-treatment follow-up. A total of 160 participants will be recruited and randomized into two groups. The treatment group will receive FTZ and basic treatment, while the control group will receive the placebo and basic treatment. The primary outcome is the combined outcome including the major adverse cardiovascular events, coronary restenosis, and unplanned revascularization. The combined secondary outcomes include all-cause mortality, acute coronary syndrome, ischemic stroke, heart failure, unplanned re-hospitalization mainly caused by acute complications of diabetes, other thromboembolic events, and TCM symptom indicators. The safety outcomes and adverse events will also be evaluated in this trial.Discussion: This trial evaluates the clinical effectiveness and safety of FTZ in patients with DCHD. The results are important to further explore the effectiveness of the comprehensive strategy “Tiao Gan Qi Shu Hua Zhuo” (modulating Gan, trigging key metabolic system to resolve pathogenic factors such as phlegm retention and dampness) in the prevention and control of glucolipid metabolic disorders (GLMD) including DCHD and T2DM. On the other hand, this study is the ﬁrst trial of FTZ to observe cardiovascular outcomes through long-term follow-up after treatment of DCHD, which is of great value.Trial Registration: This trial was registered in the Chinese Clinical Trial Registry on April 07, 2019 (No. ChiCTR1900022345).Keywords: type 2 diabetes mellitus, traditional Chinese medicine, clinical study
format	article
author	Wang L Xiang L Piao S Gong X Zhou W Feng W Li H Li L Wei A Zhu Q Rong X Guo J
author_facet	Wang L Xiang L Piao S Gong X Zhou W Feng W Li H Li L Wei A Zhu Q Rong X Guo J
author_sort	Wang L
title	The Efficacy and Safety of Chinese Medicine Fufang Zhenzhu Tiaozhi Capsule (FTZ) in the Treatment of Diabetic Coronary Heart Disease: Study Protocol for Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial
title_short	The Efficacy and Safety of Chinese Medicine Fufang Zhenzhu Tiaozhi Capsule (FTZ) in the Treatment of Diabetic Coronary Heart Disease: Study Protocol for Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial
title_full	The Efficacy and Safety of Chinese Medicine Fufang Zhenzhu Tiaozhi Capsule (FTZ) in the Treatment of Diabetic Coronary Heart Disease: Study Protocol for Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial
title_fullStr	The Efficacy and Safety of Chinese Medicine Fufang Zhenzhu Tiaozhi Capsule (FTZ) in the Treatment of Diabetic Coronary Heart Disease: Study Protocol for Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial
title_full_unstemmed	The Efficacy and Safety of Chinese Medicine Fufang Zhenzhu Tiaozhi Capsule (FTZ) in the Treatment of Diabetic Coronary Heart Disease: Study Protocol for Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial
title_sort	efficacy and safety of chinese medicine fufang zhenzhu tiaozhi capsule (ftz) in the treatment of diabetic coronary heart disease: study protocol for multicenter, randomized, double-blind, placebo-controlled clinical trial
publisher	Dove Medical Press
publishDate	2021
url	https://doaj.org/article/8968254a9d054c1693302c826cd381c9
work_keys_str_mv	AT wangl theefficacyandsafetyofchinesemedicinefufangzhenzhutiaozhicapsuleftzinthetreatmentofdiabeticcoronaryheartdiseasestudyprotocolformulticenterrandomizeddoubleblindplacebocontrolledclinicaltrial AT xiangl theefficacyandsafetyofchinesemedicinefufangzhenzhutiaozhicapsuleftzinthetreatmentofdiabeticcoronaryheartdiseasestudyprotocolformulticenterrandomizeddoubleblindplacebocontrolledclinicaltrial AT piaos theefficacyandsafetyofchinesemedicinefufangzhenzhutiaozhicapsuleftzinthetreatmentofdiabeticcoronaryheartdiseasestudyprotocolformulticenterrandomizeddoubleblindplacebocontrolledclinicaltrial AT gongx theefficacyandsafetyofchinesemedicinefufangzhenzhutiaozhicapsuleftzinthetreatmentofdiabeticcoronaryheartdiseasestudyprotocolformulticenterrandomizeddoubleblindplacebocontrolledclinicaltrial AT zhouw theefficacyandsafetyofchinesemedicinefufangzhenzhutiaozhicapsuleftzinthetreatmentofdiabeticcoronaryheartdiseasestudyprotocolformulticenterrandomizeddoubleblindplacebocontrolledclinicaltrial AT fengw theefficacyandsafetyofchinesemedicinefufangzhenzhutiaozhicapsuleftzinthetreatmentofdiabeticcoronaryheartdiseasestudyprotocolformulticenterrandomizeddoubleblindplacebocontrolledclinicaltrial AT lih theefficacyandsafetyofchinesemedicinefufangzhenzhutiaozhicapsuleftzinthetreatmentofdiabeticcoronaryheartdiseasestudyprotocolformulticenterrandomizeddoubleblindplacebocontrolledclinicaltrial AT lil theefficacyandsafetyofchinesemedicinefufangzhenzhutiaozhicapsuleftzinthetreatmentofdiabeticcoronaryheartdiseasestudyprotocolformulticenterrandomizeddoubleblindplacebocontrolledclinicaltrial AT weia theefficacyandsafetyofchinesemedicinefufangzhenzhutiaozhicapsuleftzinthetreatmentofdiabeticcoronaryheartdiseasestudyprotocolformulticenterrandomizeddoubleblindplacebocontrolledclinicaltrial AT zhuq theefficacyandsafetyofchinesemedicinefufangzhenzhutiaozhicapsuleftzinthetreatmentofdiabeticcoronaryheartdiseasestudyprotocolformulticenterrandomizeddoubleblindplacebocontrolledclinicaltrial AT rongx theefficacyandsafetyofchinesemedicinefufangzhenzhutiaozhicapsuleftzinthetreatmentofdiabeticcoronaryheartdiseasestudyprotocolformulticenterrandomizeddoubleblindplacebocontrolledclinicaltrial AT guoj theefficacyandsafetyofchinesemedicinefufangzhenzhutiaozhicapsuleftzinthetreatmentofdiabeticcoronaryheartdiseasestudyprotocolformulticenterrandomizeddoubleblindplacebocontrolledclinicaltrial AT wangl efficacyandsafetyofchinesemedicinefufangzhenzhutiaozhicapsuleftzinthetreatmentofdiabeticcoronaryheartdiseasestudyprotocolformulticenterrandomizeddoubleblindplacebocontrolledclinicaltrial AT xiangl efficacyandsafetyofchinesemedicinefufangzhenzhutiaozhicapsuleftzinthetreatmentofdiabeticcoronaryheartdiseasestudyprotocolformulticenterrandomizeddoubleblindplacebocontrolledclinicaltrial AT piaos efficacyandsafetyofchinesemedicinefufangzhenzhutiaozhicapsuleftzinthetreatmentofdiabeticcoronaryheartdiseasestudyprotocolformulticenterrandomizeddoubleblindplacebocontrolledclinicaltrial AT gongx efficacyandsafetyofchinesemedicinefufangzhenzhutiaozhicapsuleftzinthetreatmentofdiabeticcoronaryheartdiseasestudyprotocolformulticenterrandomizeddoubleblindplacebocontrolledclinicaltrial AT zhouw efficacyandsafetyofchinesemedicinefufangzhenzhutiaozhicapsuleftzinthetreatmentofdiabeticcoronaryheartdiseasestudyprotocolformulticenterrandomizeddoubleblindplacebocontrolledclinicaltrial AT fengw efficacyandsafetyofchinesemedicinefufangzhenzhutiaozhicapsuleftzinthetreatmentofdiabeticcoronaryheartdiseasestudyprotocolformulticenterrandomizeddoubleblindplacebocontrolledclinicaltrial AT lih efficacyandsafetyofchinesemedicinefufangzhenzhutiaozhicapsuleftzinthetreatmentofdiabeticcoronaryheartdiseasestudyprotocolformulticenterrandomizeddoubleblindplacebocontrolledclinicaltrial AT lil efficacyandsafetyofchinesemedicinefufangzhenzhutiaozhicapsuleftzinthetreatmentofdiabeticcoronaryheartdiseasestudyprotocolformulticenterrandomizeddoubleblindplacebocontrolledclinicaltrial AT weia efficacyandsafetyofchinesemedicinefufangzhenzhutiaozhicapsuleftzinthetreatmentofdiabeticcoronaryheartdiseasestudyprotocolformulticenterrandomizeddoubleblindplacebocontrolledclinicaltrial AT zhuq efficacyandsafetyofchinesemedicinefufangzhenzhutiaozhicapsuleftzinthetreatmentofdiabeticcoronaryheartdiseasestudyprotocolformulticenterrandomizeddoubleblindplacebocontrolledclinicaltrial AT rongx efficacyandsafetyofchinesemedicinefufangzhenzhutiaozhicapsuleftzinthetreatmentofdiabeticcoronaryheartdiseasestudyprotocolformulticenterrandomizeddoubleblindplacebocontrolledclinicaltrial AT guoj efficacyandsafetyofchinesemedicinefufangzhenzhutiaozhicapsuleftzinthetreatmentofdiabeticcoronaryheartdiseasestudyprotocolformulticenterrandomizeddoubleblindplacebocontrolledclinicaltrial
_version_	1718380980957347840
spelling	oai:doaj.org-article:8968254a9d054c1693302c826cd381c92021-12-02T17:22:58ZThe Efficacy and Safety of Chinese Medicine Fufang Zhenzhu Tiaozhi Capsule (FTZ) in the Treatment of Diabetic Coronary Heart Disease: Study Protocol for Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial1178-7007https://doaj.org/article/8968254a9d054c1693302c826cd381c92021-06-01T00:00:00Zhttps://www.dovepress.com/the-efficacy-and-safety-of-chinese-medicine-fufang-zhenzhu-tiaozhi-cap-peer-reviewed-fulltext-article-DMSOhttps://doaj.org/toc/1178-7007Lexun Wang,1 Lei Xiang,1,2 Shenghua Piao,1 Xiao Gong,3 Wanxing Zhou,4 Weixun Feng,5 Huilin Li,6 Leyu Li,7 Aisheng Wei,8 Qing Zhu,1 Xianglu Rong,1 Jiao Guo1,2 1Guangdong Metabolic Diseases Research Center of Integrated Chinese and Western Medicine; Key Laboratory of Glucolipid Metabolic Disorder, Ministry of Education of China; Institute of Chinese Medicine, Guangdong Pharmaceutical University; Guangdong TCM Key Laboratory for Metabolic Diseases, Guangzhou, People’s Republic of China; 2The First Affiliated Hospital of Guangdong Pharmaceutical University, Guangzhou, People’s Republic of China; 3School of Public Health, Guangdong Pharmaceutical University, Guangzhou, People’s Republic of China; 4Department of Internal Cardiology, The First Affiliated Hospital of Guangdong Pharmaceutical University, Guangzhou, People’s Republic of China; 5Famous Doctor’s Studio, Qingyuan Hospital of Traditional Chinese Medicine, Qingyuan, People’s Republic of China; 6Department of Endocrinology, Shenzhen Traditional Chinese Medicine Hospital, The Fourth Clinical Medical College of Guangzhou University of Chinese Medicine, Shenzhen, People’s Republic of China; 7Department of Endocrinology, Zhongshan Hospital of Traditional Chinese Medicine, Zhongshan, People’s Republic of China; 8Department of Endocrinology, Foshan Hospital of Traditional Chinese Medicine, Foshan, People’s Republic of ChinaCorrespondence: Jiao GuoGuangdong Metabolic Diseases Research Center of Integrated Chinese and Western Medicine; Key Laboratory of Glucolipid Metabolic Disorder, Ministry of Education of China; Institute of Chinese Medicine, Guangdong Pharmaceutical University; Guangdong TCM Key Laboratory for Metabolic Diseases, Guangzhou, People’s Republic of ChinaTel +86-02-39352818Fax +86-02-39352607Email gyguoyz@163.comBackground: Diabetic coronary heart disease (DCHD), the main macrovascular complication of type 2 diabetes mellitus (T2DM), is greatly harmful to T2DM patients. Traditional Chinese medicine (TCM) is an alternative and effective therapy to delay the development of macrovascular diseases, but the existing evidence of its efﬁcacy and safety is insufﬁcient. The aim of this multicenter, randomized, double-blind, placebo-controlled trial is to evaluate the efﬁcacy and safety of Chinese Medicine Fufang Zhenzhu Tiaozhi capsule (FTZ) in treating DCHD.Patients and Methods: This study includes a 2-week run-in, 52-week treatment, and 52-week post-treatment follow-up. A total of 160 participants will be recruited and randomized into two groups. The treatment group will receive FTZ and basic treatment, while the control group will receive the placebo and basic treatment. The primary outcome is the combined outcome including the major adverse cardiovascular events, coronary restenosis, and unplanned revascularization. The combined secondary outcomes include all-cause mortality, acute coronary syndrome, ischemic stroke, heart failure, unplanned re-hospitalization mainly caused by acute complications of diabetes, other thromboembolic events, and TCM symptom indicators. The safety outcomes and adverse events will also be evaluated in this trial.Discussion: This trial evaluates the clinical effectiveness and safety of FTZ in patients with DCHD. The results are important to further explore the effectiveness of the comprehensive strategy “Tiao Gan Qi Shu Hua Zhuo” (modulating Gan, trigging key metabolic system to resolve pathogenic factors such as phlegm retention and dampness) in the prevention and control of glucolipid metabolic disorders (GLMD) including DCHD and T2DM. On the other hand, this study is the ﬁrst trial of FTZ to observe cardiovascular outcomes through long-term follow-up after treatment of DCHD, which is of great value.Trial Registration: This trial was registered in the Chinese Clinical Trial Registry on April 07, 2019 (No. ChiCTR1900022345).Keywords: type 2 diabetes mellitus, traditional Chinese medicine, clinical studyWang LXiang LPiao SGong XZhou WFeng WLi HLi LWei AZhu QRong XGuo JDove Medical Pressarticletype 2 diabetes mellitustraditional chinese medicineclinical studySpecialties of internal medicineRC581-951ENDiabetes, Metabolic Syndrome and Obesity: Targets and Therapy, Vol Volume 14, Pp 2651-2659 (2021)

The Efficacy and Safety of Chinese Medicine Fufang Zhenzhu Tiaozhi Capsule (FTZ) in the Treatment of Diabetic Coronary Heart Disease: Study Protocol for Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial

Ejemplares similares