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

Your Location：

Home >

Browse articles >

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

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
- Chinese Journal of Integrative Medicine Vol. 24, Issue 10, Pages: 728-733(2018)
- 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
  CLC：
- Published：2018，
  
  Published Online：18 June 2018，
Scan for full text
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 24(10):728-733(2018)
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 24(10):728-733(2018) 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

references

Origanization WH. Global status report on noncommunicable diseases 2014. Geneva, Switzerland: World Health Origanization 2014.

Chistiakov DA. Diabetic retinopathy: pathogenic mechanisms and current treatments. Diabetes Metab Syndr 2011;5:165–172.

Dedania VS, Bakri SJ. Novel pharmacotherapies in diabetic retinopathy. Middle East Afr J Ophthalmol 2015;22:164–173.

Cheng X, Nayyar S, Wang M, Li X, Sun Y, Huang W, et al. Mortality rates among prevalent hemodialysis patients in Beijing: a comparison with USRDS data. Nephrol Dialysis Transpl 2013;28:724–732.

Vupputuri S, Kimes TM, Calloway MO, Christian JB, Bruhn D, Martin AA, et al. The economic burden of progressive chronic kidney disease among patients with type 2 diabetes. J Diabetes Compl 2014;28:10–16.

Duan JG, Jin M, Jie CH, Ye HJ. Standard of TCM diagnosis and treatment of diabetic retinal lesions. World J Intergr Tradit West Med (Chin) 2011;6:632–637.

Chen G, Wu X, Yang X, Yan M, Li P. Using the Delphi method to survey clinical experts on the characteristics of traditional Chinese syptoms of diabetic nephropathy. China J Tradit Chin Med Pharm (Chin) 2011;26:2241–2244.

Duan JG, Liao LZ, Wu L, Li YM, Yu YG, Qiu B. Randomized controlled double-blind multicentric clinical trail on non-proliferative diabetic retinopathy treated by Qiming Granule. J Chengdu Univ Tradit Chin Med (Chin) 2006;29:1–5.

Luo XX, Duan JG, Liao PZ, Wu L, Yu YG, Qiu B, et al. Effect of Qiming Granule on retinal blood circulation of diabetic retinopathy: a multicenter clinical trial. Chin J Integr Med 2009;15:384–388.

Vasant More S, Kim IS, Choi DK. Recent update on the role of Chinese material medica and formulations in diabetic retinopathy. Molecules 2017;22:76.

Zhao H, Li X, Zhao T, Zhang H, Yan M, Dong X, et al. Tangshen formula attenuates diabetic renal injuries by upregulating autophagy via inhibition of PLZF expression. PLoS One 2017;12:e0171475.

Pang B, Zhao TY, Zhao LH, Wan F, Ye R, Zhou Q, et al. Huangqi Guizhi Wuwu Decoction for treating diabetic peripheral neuropathy: a meta-analysis of 16 randomized controlled trials. Neural regeneration research 2016;11:1347–1358.

American Diabetes A. Standards of medical care in diabetes—2013. Diabetes Care 2013;36 Suppl 1:S11–S66.

Wilkinson CP, Ferris FL 3rd, Klein RE, Lee PP, Agardh CD, Davis M, et al. Proposed international clinical diabetic retinopathy and diabetic macular edema disease severity scales. Ophthalmology 2003;110:1677–1682.

Inker LA, Astor BC, Fox CH, Isakova T, Lash JP, Peralta CA, et al. KDOQI US commentary on the 2012 KDIGO clinical practice guideline for the evaluation and management of CKD. Am J Kidney Dis 2014;63:713–735.

Ma YC, Zuo L, Chen JH, Luo Q, Yu XQ, Li Y, et al. Modified glomerular filtration rate estimating equation for Chinese patients with chronic kidney disease. J Am Soci Nephrol 2006;17:2937–2944.

Boulton AJ, Vinik AI, Arezzo JC, Bril V, Feldman EL, Freeman R, et al. Diabetic neuropathies: a statement by the American Diabetes Association. Diabetes Care 2005;28:956–962.

Zheng XY, ed. Clinical research guideline of new investigational drug in traditional Chinese medicine. Beijing: China Medical Science Press; 2002.

Zhang LL. Study on Preparation technology and quality standard of QMG ranule [Dissertation]. School of Pharmacy, Zhejiang University: 2008.

Li HC, Xu YY. Clinical efficacy review and economic evaluation of Qiming Granule for diabetic retinopathy. Drugs and Clinic (Chin) 2014;11(2):33–39.

FULL TEXT LINK

More>

Views

Downloads

CSCD

Alert me when the article has been cited

Submit

Tools

Publicity Resources

A randomized controlled trial of adjunctive Bunchang Naoxintong Capsule (步长脑心通胶囊) versus maintenance dose clopidogrel in patients with CYP2C19*2 polymorphism

Astragalus membranaceus Injection combined with conventional treatment for viral myocarditis: A systematic review of randomized controlled trials

Efficacy of externally applied Chinese herbal drugs in treating psoriasis: A systematic review

Parallel subgroup design of a randomized controlled clinical trial—comparing the approaches of Chinese medicine and Western medicine

Effect of Shenzhu Guanxin Recipe (参术冠心方) on patients with angina pectoris after percutaneous coronary intervention: A prospective, randomized controlled trial

Related Author

No data

Related Institution

Fujian Provincial Cardiovascular Disease Institute, Provincial Clinical College of Fujian Medical University

Department of Traditional Chinese Medicine, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences

The First Hospital of Beijing University of Chinese Medicine

Department of Dermatology, China-Japan Friendship Hospital, Beijng

Janssen Pharmaceutical Ltd., Beijing

Address：1 Caochang, xiyuan, Beijing, People's Republic of China Postal code：100091
Tel：010-62886827, 62877592 Fax：010-62874291
Technical support is provided by Beijing Founder electronics co., LTD 京ICP备05067934号-1 京公网安备11010802024621
It is recommended to read the content of this site in Chrome&IE9+. Please switch to extreme mode in browser 360.
Cookies We use cookies to help provide and enhance our service and tailor content. By continuing, you agree to the use of cookies.

⁰