Stationary Treatment Compared with Individualized Chinese Medicine for Type 2 Diabetes Patients with Microvascular Complications: Study Protocol for a Randomized Controlled Trial

Huo, Jiuyuan; Li, Lisha; Jian, Wenyuan; Zeng, Jieping; Duan, Junguo; Lu, Xuejing; Yin, Shuo

doi:10.1007/s11655-018-2987-1

Cited by 2 publications

(1 citation statement)

References 13 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Recently, there are some randomized controlled trials (RCTs) conducted to evaluate the efficacy of TCM for CHD and diabetes. [20][21][22][23][24][37][38][39] In diabetic macroangiopathy, there is an ongoing RCT about the efficacy and safety of Shen-Qi Hua-Yu formula in the treatment of diabetic lower extremity artery disease. 17 Besides, recent clinical study has shown that Jiangtang Tongmai capsule could reduce the carotid intima-media thickness and the area of arterial plaque in the treatment of diabetic macroangiopathy.…”

Section: Discussionmentioning

confidence: 99%

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

Wang

Xiang

Piao

et al. 2021

DMSO

View full text Add to dashboard Cite

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).

show abstract