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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

Background Diabetic peripheral neuropathy is a common complication of diabetes and the main cause of disability. At present, there is no specific therapeutic regimen. Mecobalamin is often used as a neurotrophic drug, and its long-term effects are not satisfactory when used alone. Clinical practice indicates that traditional Chinese medicine injection with mecobalamin has a therapeutic advantage in treating diabetic peripheral neuropathy while it lacks evidence-based medicine. In this scheme, the efficacy and safety of traditional Chinese medicine injection with mecobalamin in treating diabetic peripheral neuropathy has been studied. Methods Computers were used to search the English database (PubMed, the Cochrane Library, Embase, Web of Science), and Chinese database (CNKI, Wanfang, CBMDISC, VIP). Besides, manual searching was conducted to search for Baidu Scholar, CHICTR, Google Scholar. During the establishment of the database to November 2020, a randomized controlled trial on traditional Chinese medicine injection with mecobalamin in treating diabetic peripheral neuropathy was conducted. There were 2 researchers independently conducting data extraction and quality evaluation of literature on the included studies, RevMan5.3 was performed for meta-analysis on the included literature. Results In this study, the efficacy and safety of traditional Chinese medicine injection with mecobalamin in treating diabetic peripheral neuropathy was evaluated by the total effective rate, motor nerve conduction velocity, sensory nerve conduction velocity, adverse reactions, and glucose metabolism level. Conclusion This study can provide an evidence-based basis on the clinical applications of traditional Chinese medicine injection with mecobalamin in the treatment of diabetic peripheral neuropathy. Ethics and dissemination The study does not involve patient privacy or rights and does not require approval from an ethics committee. The results may be published in peer-reviewed journals or disseminated at relevant conferences. Osf registration number DOI 10.17605/OSF.IO/KPW5E.

Objective: To explore the ameliorative effect and mechanism of Panax notoginseng (PNG) and Ticlid in treating early diabetic nephropathy (DN).Method: Fifty-eight patients were divided randomly into two groups, 28 patients of the Ticlid group treated with Ticlid 250 mg orally, once a day and 30 patients of the PNG group treated with PNG 8 ml in 250 ml of normal saline intravenous drip once a day. The therapeutic effect and relative indexes of the two groups were observed and compared.Results: After treatment, in both groups, the thromboxane B2 markedly reduced and was more prominent in the Ticlid group (P