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; Lei Xiang; Shenghua Piao; Xiao Gong; Wanxing Zhou; Weixun Feng; Huilin Li; Leyu Li; Aisheng Wei; Qing Zhu; Xianglu Rong; Jiao Guo

doi:10.2147/DMSO.S309419

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

Diabetes Metab Syndr Obes. 2021 Jun 14:14:2651-2659. doi: 10.2147/DMSO.S309419. eCollection 2021.

Authors

Lexun Wang¹, Lei Xiang^{1

2}, Shenghua Piao¹, Xiao Gong³, Wanxing Zhou⁴, Weixun Feng⁵, Huilin Li⁶, Leyu Li⁷, Aisheng Wei⁸, Qing Zhu¹, Xianglu Rong¹, Jiao Guo^{1

2}

Affiliations

¹ Guangdong 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.
² The First Affiliated Hospital of Guangdong Pharmaceutical University, Guangzhou, People's Republic of China.
³ School of Public Health, Guangdong Pharmaceutical University, Guangzhou, People's Republic of China.
⁴ Department of Internal Cardiology, The First Affiliated Hospital of Guangdong Pharmaceutical University, Guangzhou, People's Republic of China.
⁵ Famous Doctor's Studio, Qingyuan Hospital of Traditional Chinese Medicine, Qingyuan, People's Republic of China.
⁶ Department of Endocrinology, Shenzhen Traditional Chinese Medicine Hospital, The Fourth Clinical Medical College of Guangzhou University of Chinese Medicine, Shenzhen, People's Republic of China.
⁷ Department of Endocrinology, Zhongshan Hospital of Traditional Chinese Medicine, Zhongshan, People's Republic of China.
⁸ Department of Endocrinology, Foshan Hospital of Traditional Chinese Medicine, Foshan, People's Republic of China.

Abstract

Background: 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: clinical study; traditional Chinese medicine; type 2 diabetes mellitus.

Grants and funding

This work was supported by the National Key Research and Development Program of China (2018YFC1704200), the Major basic and applied basic research projects of Guangdong Province of China (2019B030302005), and the Key Project of National Natural Science Foundation of China (81530102).