PMID- 34149404
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20210622
IS  - 1663-9812 (Print)
IS  - 1663-9812 (Electronic)
IS  - 1663-9812 (Linking)
VI  - 12
DP  - 2021
TI  - 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.
PG  - 625785
LID - 10.3389/fphar.2021.625785 [doi]
LID - 625785
AB  - 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.
CI  - Copyright (c) 2021 Wang, Guo, Lei, Huang, Dou, Li, Zhao, Fu, Zhou, Wan, Zhao and 
      Yang.
FAU - Wang, Yu
AU  - Wang Y
AD  - School of Life Sciences, Zhejiang Chinese Medical University, Hangzhou, China.
FAU - Guo, Yilei
AU  - Guo Y
AD  - School of Basic Medical Sciences, Zhejiang Chinese Medical University, Hangzhou, 
      China.
FAU - Lei, Ye
AU  - Lei Y
AD  - Department of Endocrinology and Metabolism, The Second Affiliated Hospital of 
      Shaanxi University of Traditional Chinese Medicine, Xianyang, China.
FAU - Huang, Shuwei
AU  - Huang S
AD  - Department of Cardiology, The First Affiliated Hospital of Zhejiang Chinese 
      Medical University, Xianyang, China.
FAU - Dou, Liping
AU  - Dou L
AD  - Department of Cardiology, The Second Affiliated Hospital of Zhejiang Chinese 
      Medical University, Hangzhou, China.
FAU - Li, Chang
AU  - Li C
AD  - School of Life Sciences, Zhejiang Chinese Medical University, Hangzhou, China.
FAU - Zhao, Buchang
AU  - Zhao B
AD  - Department of Brain and Heart CO Treatment, Xi'an Buchang Traditional Chinese 
      Medicine Cardiac-Cerebral Diseases Hospital, Xi'an, China.
FAU - Fu, Wei
AU  - Fu W
AD  - Department of Cardiac-Cerebral Diseases, Yinchuan Cardiac-Cerebral Treatment 
      Internet Hospital, Yinchuan, China.
FAU - Zhou, Peng
AU  - Zhou P
AD  - Institute of Brain and Heart CO Treatment, Zhejiang Chinese Medical University, 
      Hangzhou, China.
FAU - Wan, Haitong
AU  - Wan H
AD  - School of Life Sciences, Zhejiang Chinese Medical University, Hangzhou, China.
FAU - Zhao, Mingjun
AU  - Zhao M
AD  - Department of Cardiovascular, Affiliated Hospital of Shaanxi University of 
      Traditional Chinese Medicine, Xianyang, China.
FAU - Yang, Jiehong
AU  - Yang J
AD  - School of Basic Medical Sciences, Zhejiang Chinese Medical University, Hangzhou, 
      China.
LA  - eng
PT  - Journal Article
DEP - 20210603
PL  - Switzerland
TA  - Front Pharmacol
JT  - Frontiers in pharmacology
JID - 101548923
PMC - PMC8209367
OTO - NOTNLM
OT  - Chinese medicine
OT  - coronary heart disease
OT  - randomized controlled trial
OT  - tongmai jiangtang capsules
OT  - type 2 diabetes mellitus
COIS- The authors declare that the research was conducted in the absence of any 
      commercial or financial relationships that could be construed as a potential 
      conflict of interest.
EDAT- 2021/06/22 06:00
MHDA- 2021/06/22 06:01
PMCR- 2021/06/03
CRDT- 2021/06/21 05:50
PHST- 2021/01/24 00:00 [received]
PHST- 2021/05/05 00:00 [accepted]
PHST- 2021/06/21 05:50 [entrez]
PHST- 2021/06/22 06:00 [pubmed]
PHST- 2021/06/22 06:01 [medline]
PHST- 2021/06/03 00:00 [pmc-release]
AID - 625785 [pii]
AID - 10.3389/fphar.2021.625785 [doi]
PST - epublish
SO  - Front Pharmacol. 2021 Jun 3;12:625785. doi: 10.3389/fphar.2021.625785. 
      eCollection 2021.