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

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Abstract

Background

Microvascular complications in type 2 diabetes (T2DM), including diabatic retinopathy (DR), diabetic kidney disease (DKD), diabetic peripheral neuropathy (DPN) are the leading causes of visual loss, end-stage renal disease or amputation, while the current therapies are still unsatisfactory. Chinese medicine (CM) has been widely used for treating diabetic mellitus. However, most of the previous studies focused on the single complication. The role of CM treatment in T2DM patients with 2 or multiple microvascular complications is not clear.

Objective

To appraise the curative effect of CM in T2DM patients with 2 or multiple microvascular complications, and to compare the effects of stationary treatment and individualized treatment in T2DM patients with microvascular complications.

Methods

This trial will be an 8-center, randomized, controlled study with 8 parallel groups. A total of 432 patients will be randomized to 8 groups: DR study group (32 cases) and a corresponding control group (32 cases), DR+DKD study group (64 cases) and a corresponding control group (64 cases), DR+DPN study group (64 cases) and a corresponding control group (64 cases), DR+DKD+DPN study group (56 cases) and a corresponding control group (56 cases). The control group will receive stationary treatment, and the study group will receive individualized treatment based on CM syndrome differentiation in addition to stationary treatment. The study duration will be 50 weeks, comprising a 2-week run-in period, 24 weeks of intervention, and 24 weeks of follow-up. The outcomes will assess efficacy of treatment, improvement in CM symptoms, safety assessments, adherence to the treatment, and adverse events.

Conclusion

This study will provide evidence of evidence-based medicine for CM treatment in two or multiple microvascular complications caused by T2DM. (Registration No. ChiCTR-IPR-15007072)

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Acknowledgements

The authors would like to thank all the subjects participating at the current study.

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Authors and Affiliations

  1. College of Ophthalmology, Chengdu University of Traditional Chinese Medicine, Chengdu, 610075, China

    Jian Huo, Wen-yuan Jian, Jun-guo Duan, Xue-jing Lu & Shuo Yin

  2. Good Clinical Practice Center, the Affiliated Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, 610075, China

    Li-sha Liu & Jie-ping Zeng

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  1. Jian Huo
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  2. Li-sha Liu
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  3. Wen-yuan Jian
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Corresponding author

Correspondence to Jun-guo Duan.

Additional information

Supported by the National Key Technology Support Program of China and the State Administration of Traditional Medicine of China (No. 2014BAI10B03)

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Huo, J., Liu, Ls., Jian, Wy. et al. Stationary Treatment Compared with Individualized Chinese Medicine for Type 2 Diabetes Patients with Microvascular Complications: Study Protocol for a Randomized Controlled Trial. Chin. J. Integr. Med. 24, 728–733 (2018). https://doi.org/10.1007/s11655-018-2987-1

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  • DOI: https://doi.org/10.1007/s11655-018-2987-1

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