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Chinese herbal medicine TangBi Formula treatment of patients with type 2 diabetic distal symmetric polyneuropathy disease: study protocol for a randomized controlled trial
- Source :
- Trials, Trials, Vol 18, Iss 1, Pp 1-10 (2017)
- Publication Year :
- 2017
-
Abstract
- Background Diabetic distal symmetric polyneuropathy (DSPN) is one of the most common microvascular complications of diabetes mellitus, and it has become a major public health problem worldwide because of its high and increasing prevalence, morbidity, and disability rate. The current medications for DSPN are not entirely satisfactory. Preliminary studies indicated that the Chinese herbal TangBi Formula may alleviate signs and symptoms and improve the velocity of nerve conduction in patients with DSPN. This study was designed to determine if Chinese herbal medicine used in combination with conventional treatment is more effective than conventional treatment alone. Methods/design We are conducting a multicenter, placebo-controlled, double-blind, randomized, controlled clinical trial as a means of assessing the therapeutic effects of traditional Chinese medicine (TCM) treatment. A total of 188 patients will be randomized in a 1:1 ratio to a treatment group (TangBi Formula plus mecobalamin) and a control group (placebo plus mecobalamin). The test period lasts 6 months, during which all of the patients will be given standard medical care as recommended by established guidelines. The primary outcome will be development of differences in changes in clinical symptoms and signs in patients and changes in Michigan Diabetic Neuropathy Score (MDNS) between the two groups before and after treatment. The secondary outcome will be changes in nerve conduction velocity and in single clinical signs and symptoms. Safety assessments and adverse events will also be evaluated. Discussion We postulate that patients with DSPN will benefit from therapy that includes TCM. If successful, this work will provide an evidence-based complementary therapeutic approach for treatment of DSPN. Trial registration ClinicalTrials.gov, NCT03010241. Registered on 2 January 2017 Electronic supplementary material The online version of this article (doi:10.1186/s13063-017-2345-1) contains supplementary material, which is available to authorized users.
- Subjects :
- Adult
medicine.medical_specialty
Diabetic neuropathy
Diabetic distal symmetric polyneuropathy
0211 other engineering and technologies
Medicine (miscellaneous)
02 engineering and technology
Traditional Chinese medicine
Placebo
law.invention
03 medical and health sciences
Study Protocol
0302 clinical medicine
Clinical trials
Randomized controlled trial
Diabetic Neuropathies
Double-Blind Method
law
Internal medicine
Diabetes mellitus
021105 building & construction
Outcome Assessment, Health Care
Medicine
Humans
Multicenter Studies as Topic
Pharmacology (medical)
030212 general & internal medicine
Medicine, Chinese Traditional
Adverse effect
Aged
Randomized Controlled Trials as Topic
lcsh:R5-920
business.industry
Therapeutic effect
Middle Aged
medicine.disease
Clinical trial
Treatment
Diabetes Mellitus, Type 2
lcsh:Medicine (General)
business
Drugs, Chinese Herbal
Subjects
Details
- ISSN :
- 17456215
- Volume :
- 18
- Issue :
- 1
- Database :
- OpenAIRE
- Journal :
- Trials
- Accession number :
- edsair.doi.dedup.....2cc804f72fa4706e95bf2f54e7996958