Design and Methodology of a Multicenter Randomized Clinical Trial to Evaluate the Efficacy of Tongmai Jiangtang Capsules in Type 2 Diabetic Coronary Heart Disease Patients
Background: Population-based studies have consistently showed an increased incidence of coronary heart disease and cardiac mortality in patients with type 2 diabetes mellitus (T2DM). Tongmai Jiangtang capsules (TJC) are Chinese patent medicines that have been approved in China for the treatment of d...
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Frontiers Media S.A.
2021-06-01
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| Series: | Frontiers in Pharmacology |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fphar.2021.625785/full |
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| author | Yu Wang Yilei Guo Ye Lei Shuwei Huang Liping Dou Chang Li Buchang Zhao Wei Fu Peng Zhou Haitong Wan Mingjun Zhao Jiehong Yang |
| author_facet | Yu Wang Yilei Guo Ye Lei Shuwei Huang Liping Dou Chang Li Buchang Zhao Wei Fu Peng Zhou Haitong Wan Mingjun Zhao Jiehong Yang |
| author_sort | Yu Wang |
| collection | DOAJ |
| description | Background: Population-based studies have consistently showed an increased incidence of coronary heart disease and cardiac mortality in patients with type 2 diabetes mellitus (T2DM). Tongmai Jiangtang capsules (TJC) are Chinese patent medicines that have been approved in China for the treatment of diabetic vascular complications. However, the evidence supporting the efficacy of Tongmai Jiangtang capsules in type 2 diabetic coronary heart disease (T2DM-CHD) remains unclear. Herein, we designed a randomized, parallel-controlled clinical trial to investigate a new complementary therapy for T2DM-CHD patients.Methods: A total of 360 T2DM-CHD subjects (aged 18–75 years) will be randomly assigned to the TJC group or the placebo group at a 2:1 ratio. On the basis of western medicine therapy, all the participants will receive TJC or placebo, orally, three capsules/treatment, three per day for 12 weeks. The primary outcomes will be assessed according to the Canadian Cardiovascular Society (CCS) classification. All statistical analyses will be performed setting a two-sided 0.05 significance level, using SAS 9.4 statistical software.Discussion: The efficacy of TJC for the treatment of T2DM-CHD patients will be evaluated. The study will provide reliable clinical research evidence for application of TJC in treating T2DM-CHD patients.Clinical Trial Registration:https://www.chictr.org.cn/enIndex.aspx, Chinese Clinical Trial Registry ChiCTR2000037491. |
| first_indexed | 2024-12-14T16:07:10Z |
| format | Article |
| id | doaj.art-c1820c18574d49a09bd253ad279a44c4 |
| institution | Directory Open Access Journal |
| issn | 1663-9812 |
| language | English |
| last_indexed | 2024-12-14T16:07:10Z |
| publishDate | 2021-06-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Pharmacology |
| spelling | doaj.art-c1820c18574d49a09bd253ad279a44c42022-12-21T22:55:04ZengFrontiers Media S.A.Frontiers in Pharmacology1663-98122021-06-011210.3389/fphar.2021.625785625785Design and Methodology of a Multicenter Randomized Clinical Trial to Evaluate the Efficacy of Tongmai Jiangtang Capsules in Type 2 Diabetic Coronary Heart Disease PatientsYu Wang0Yilei Guo1Ye Lei2Shuwei Huang3Liping Dou4Chang Li5Buchang Zhao6Wei Fu7Peng Zhou8Haitong Wan9Mingjun Zhao10Jiehong Yang11School of Life Sciences, Zhejiang Chinese Medical University, Hangzhou, ChinaSchool of Basic Medical Sciences, Zhejiang Chinese Medical University, Hangzhou, ChinaDepartment of Endocrinology and Metabolism, The Second Affiliated Hospital of Shaanxi University of Traditional Chinese Medicine, Xianyang, ChinaDepartment of Cardiology, The First Affiliated Hospital of Zhejiang Chinese Medical University, Xianyang, ChinaDepartment of Cardiology, The Second Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, ChinaSchool of Life Sciences, Zhejiang Chinese Medical University, Hangzhou, ChinaDepartment of Brain and Heart CO Treatment, Xi'an Buchang Traditional Chinese Medicine Cardiac-Cerebral Diseases Hospital, Xi'an, ChinaDepartment of Cardiac-Cerebral Diseases, Yinchuan Cardiac-Cerebral Treatment Internet Hospital, Yinchuan, ChinaInstitute of Brain and Heart CO Treatment, Zhejiang Chinese Medical University, Hangzhou, ChinaSchool of Life Sciences, Zhejiang Chinese Medical University, Hangzhou, ChinaDepartment of Cardiovascular, Affiliated Hospital of Shaanxi University of Traditional Chinese Medicine, Xianyang, ChinaSchool of Basic Medical Sciences, Zhejiang Chinese Medical University, Hangzhou, ChinaBackground: Population-based studies have consistently showed an increased incidence of coronary heart disease and cardiac mortality in patients with type 2 diabetes mellitus (T2DM). Tongmai Jiangtang capsules (TJC) are Chinese patent medicines that have been approved in China for the treatment of diabetic vascular complications. However, the evidence supporting the efficacy of Tongmai Jiangtang capsules in type 2 diabetic coronary heart disease (T2DM-CHD) remains unclear. Herein, we designed a randomized, parallel-controlled clinical trial to investigate a new complementary therapy for T2DM-CHD patients.Methods: A total of 360 T2DM-CHD subjects (aged 18–75 years) will be randomly assigned to the TJC group or the placebo group at a 2:1 ratio. On the basis of western medicine therapy, all the participants will receive TJC or placebo, orally, three capsules/treatment, three per day for 12 weeks. The primary outcomes will be assessed according to the Canadian Cardiovascular Society (CCS) classification. All statistical analyses will be performed setting a two-sided 0.05 significance level, using SAS 9.4 statistical software.Discussion: The efficacy of TJC for the treatment of T2DM-CHD patients will be evaluated. The study will provide reliable clinical research evidence for application of TJC in treating T2DM-CHD patients.Clinical Trial Registration:https://www.chictr.org.cn/enIndex.aspx, Chinese Clinical Trial Registry ChiCTR2000037491.https://www.frontiersin.org/articles/10.3389/fphar.2021.625785/fulltongmai jiangtang capsulesChinese medicinetype 2 diabetes mellituscoronary heart diseaserandomized controlled trial |
| spellingShingle | Yu Wang Yilei Guo Ye Lei Shuwei Huang Liping Dou Chang Li Buchang Zhao Wei Fu Peng Zhou Haitong Wan Mingjun Zhao Jiehong Yang Design and Methodology of a Multicenter Randomized Clinical Trial to Evaluate the Efficacy of Tongmai Jiangtang Capsules in Type 2 Diabetic Coronary Heart Disease Patients Frontiers in Pharmacology tongmai jiangtang capsules Chinese medicine type 2 diabetes mellitus coronary heart disease randomized controlled trial |
| title | Design and Methodology of a Multicenter Randomized Clinical Trial to Evaluate the Efficacy of Tongmai Jiangtang Capsules in Type 2 Diabetic Coronary Heart Disease Patients |
| title_full | Design and Methodology of a Multicenter Randomized Clinical Trial to Evaluate the Efficacy of Tongmai Jiangtang Capsules in Type 2 Diabetic Coronary Heart Disease Patients |
| title_fullStr | Design and Methodology of a Multicenter Randomized Clinical Trial to Evaluate the Efficacy of Tongmai Jiangtang Capsules in Type 2 Diabetic Coronary Heart Disease Patients |
| title_full_unstemmed | Design and Methodology of a Multicenter Randomized Clinical Trial to Evaluate the Efficacy of Tongmai Jiangtang Capsules in Type 2 Diabetic Coronary Heart Disease Patients |
| title_short | Design and Methodology of a Multicenter Randomized Clinical Trial to Evaluate the Efficacy of Tongmai Jiangtang Capsules in Type 2 Diabetic Coronary Heart Disease Patients |
| title_sort | design and methodology of a multicenter randomized clinical trial to evaluate the efficacy of tongmai jiangtang capsules in type 2 diabetic coronary heart disease patients |
| topic | tongmai jiangtang capsules Chinese medicine type 2 diabetes mellitus coronary heart disease randomized controlled trial |
| url | https://www.frontiersin.org/articles/10.3389/fphar.2021.625785/full |
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