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Herbal medicine foot bath for the treatment of diabetic peripheral neuropathy: protocol for a randomized, double-blind and controlled trial
- Source :
- Trials, Trials, Vol 19, Iss 1, Pp 1-8 (2018)
- Publication Year :
- 2018
- Publisher :
- BioMed Central, 2018.
-
Abstract
- Background As a common complication of diabetes, the incidence of diabetic peripheral neuropathy (DPN) is 60–70% worldwide. DPN is a major risk factor for diabetic foot, which may lead to foot ulceration and even amputation. The treatment of DPN remains challenging. Our preliminary study demonstrated that the external application of Tangbi Waixi (TW) decoction to the lower extremities relieved clinical symptoms and improved nerve conduction velocity in DPN patients. The aim of this study was to verify the efficacy of TW among DPN patients and evaluate the herb mixture’s safety using rigorous methodological designs. Methods/design This study is a multicenter, double-blind, randomized controlled trial. A total of 640 DPN patients will be recruited and randomized to receive a foot bath with either the TW decoction or control drug. Participants will be assessed at baseline and 12 and 24 weeks after treatment. The primary outcome was the change of the Toronto Clinical Scoring System (TCSS). Secondary outcomes were nerve conduction velocity, blood glucose, blood lipids, serum inflammatory cytokines, and the European Quality of Life Five-Dimension Scale (EQ-5D) and TCM symptom scores. Discussion This multicenter, prospective, randomized clinical trial will provide valuable data regarding the efficacy and safety of foot bath treatment with TW decoction. Positive results would provide a novel treatment regimen for DPN patients. Trial registration Chinese Clinical Trial Registry, ChiCTR-IOR-16009331. Registered on 8 October 2016. Electronic supplementary material The online version of this article (10.1186/s13063-018-2856-4) contains supplementary material, which is available to authorized users.
- Subjects :
- Adult
Male
medicine.medical_specialty
China
Time Factors
Adolescent
medicine.medical_treatment
Medicine (miscellaneous)
030209 endocrinology & metabolism
law.invention
03 medical and health sciences
Study Protocol
Young Adult
0302 clinical medicine
Randomized controlled trial
Double-Blind Method
law
Diabetes mellitus
Internal medicine
medicine
Humans
Multicenter Studies as Topic
Pharmacology (medical)
030212 general & internal medicine
Prospective Studies
Risk factor
Aged
Randomized Controlled Trials as Topic
lcsh:R5-920
business.industry
Baths
Middle Aged
medicine.disease
Diabetic foot
Diabetic peripheral neuropathy
Diabetic Foot
Clinical trial
Peripheral neuropathy
Treatment Outcome
Amputation
External application
Female
Chinese herbal medicine
Tangbi Waixi decoction
Complication
business
lcsh:Medicine (General)
Drugs, Chinese Herbal
Subjects
Details
- Language :
- English
- ISSN :
- 17456215
- Volume :
- 19
- Database :
- OpenAIRE
- Journal :
- Trials
- Accession number :
- edsair.doi.dedup.....01b1f27ea7f70b9bfd83763db1a52db4