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Trials
Published in: Trials 1/2015

Open Access 01-12-2015 | Study protocol

The efficacy and safety of the Chinese herbal medicine Di-Tan decoction for treating Alzheimer’s disease: protocol for a randomized controlled trial

Authors: Ka-Kit Chua, Adrian Wong, Pauline Wing-Lam Kwan, Ju-Xian Song, Lei-Lei Chen, Andrew Lung-Tat Chan, Jia-Hong Lu, Vincent Mok, Min Li

Published in: Trials | Issue 1/2015

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Abstract

Background

Alzheimer’s disease (AD) is the most common type of dementia in the elderly. It is estimated that the global prevalence of dementia will rise from 24.3 million in 2005 to 81.1 million in 2040. AD has a devastating impact on sufferers, caregivers, their communities and the healthcare system in general. “Di-tan decoction” (DTD) is a traditional Chinese medicine (TCM) formula frequently used to treat symptoms that are now defined as AD in clinical treatment. However, the existing evidence for recommending DTD in clinical practice derives from studies that were methodologically flawed. In this study, we aim to determine the efficacy and safety of DTD in AD patients based on a rigidly randomized controlled trial. It will provide critical information on sample size and treatment regimen for conducting a full-scale clinical trial of DTD later.

Methods/Design

This study will be a double-blind, randomized, placebo-controlled, add-on trial. After a 2-week run-in period, eligible patients with mild to moderate AD will be recruited and given either DTD or placebo twice daily for 24 weeks with follow-up 6 weeks after the last treatment. An increase of four points or greater on the scores of Alzheimer’s Disease Assessment Scale-cognitive subscale (ADAD-cog) will be considered as a positive primary outcome. Total scores of the ADAD-cog, the Chinese version of Mini-Mental State Examination (C-MMSE), and the Chinese version of the Disability Assessment for Dementia (C-DAD) score will be used as secondary outcomes. Adverse events will also be reported.

Discussion

This randomized trial will be the first rigorous empirical study on the efficacy of DTD for treating cognitive symptoms in AD patients. Its success will justify and warrant a large-scale clinical trial to further consolidate the evidence for DTD’s efficacy in treating AD.

Trial registration

Chinese Clinical Trial Registry (ChiCTR-TRC-12004548, Date of registration: 22 November 2012)
Appendix
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Metadata
Title
The efficacy and safety of the Chinese herbal medicine Di-Tan decoction for treating Alzheimer’s disease: protocol for a randomized controlled trial
Authors
Ka-Kit Chua
Adrian Wong
Pauline Wing-Lam Kwan
Ju-Xian Song
Lei-Lei Chen
Andrew Lung-Tat Chan
Jia-Hong Lu
Vincent Mok
Min Li
Publication date
01-12-2015
Publisher
BioMed Central
Published in
Trials / Issue 1/2015
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-015-0716-z

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