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

Jian Huo; Li-sha Liu; Wen-yuan Jian; Jie-ping Zeng; Jun-guo Duan; Xue-jing Lu; Shuo Yin

doi:10.1007/s11655-018-2987-1

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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

OriginalPaper | Updated：2021-08-27

- Stationary Treatment Compared with Individualized Chinese Medicine for Type 2 Diabetes Patients with Microvascular Complications: Study Protocol for a Randomized Controlled Trial
- Stationary Treatment Compared with Individualized Chinese Medicine for Type 2 Diabetes Patients with Microvascular Complications: Study Protocol for a Randomized Controlled Trial
- 中国结合医学杂志（英文版） 2018年24卷第10期页码：728-733
- Affiliations：
  
  1. College of Ophthalmology, Chengdu University of Traditional Chinese Medicine,Chengdu,China
  2. Good Clinical Practice Center, the Affiliated Hospital of Chengdu University of Traditional Chinese Medicine,Chengdu,China
- Author bio：
- Funds：
  
  Supported by the National Key Technology Support Program of China and the State Administration of Traditional Medicine of China (No. 2014BAI10B03)
- DOI：10.1007/s11655-018-2987-1
  中图分类号：
- 纸质出版日期：2018，
  
  网络出版日期：2018-6-18，
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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

Jian Huo, Li-sha Liu, Wen-yuan Jian, et al. Stationary Treatment Compared with Individualized Chinese Medicine for Type 2 Diabetes Patients with Microvascular Complications: Study Protocol for a Randomized Controlled Trial[J]. Chinese Journal of Integrative Medicine, 2018,24(10):728-733.
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 DOI：

Jian Huo, Li-sha Liu, Wen-yuan Jian, et al. Stationary Treatment Compared with Individualized Chinese Medicine for Type 2 Diabetes Patients with Microvascular Complications: Study Protocol for a Randomized Controlled Trial[J]. Chinese Journal of Integrative Medicine, 2018,24(10):728-733. DOI： 10.1007/s11655-018-2987-1.

摘要

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. 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. 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. 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)

Abstract

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

and to compare the effects of stationary treatment and individualized treatment in T2DM patients with microvascular complications. 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. 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)

关键词

Chinese Medicinediabetic microvascular complicationsrandomized controlled trialQiming Granule

Keywords

Chinese Medicinediabetic microvascular complicationsrandomized controlled trialQiming Granule

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