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Journal of Chinese Integrative Medicine ›› 2013, Vol. 11 ›› Issue (4): 285-290.doi: 10.3736/jintegrmed2013035

• Study Protocol • Previous Articles     Next Articles

Evaluation on the efficacy and safety of Chinese herbal medication Xifeng Dingchan Pill in treating Parkinson’s disease: Study protocol of a multicenter, open-label, randomized active-controlled trial

Jie Zhanga,b, Yun-zhi Mab(), Xiao-ming Shenb   

  1. a. Department of Cerebropathy, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing 100700, China
    b. Department of Cerebropathy, the First Affiliated Hospital, Henan University of Traditional Chinese Medicine, Zhengzhou 450008, Henan Province, China
  • Received:2013-03-02 Accepted:2013-04-02 Online:2013-07-10 Published:2013-07-15

Background

Parkinson’s disease (PD) is a complicated disease, commonly diagnosed among the elderly, which leads to degeneration of the central nervous system. It presently lacks an effective therapy for its complex pathogenesis. Adverse effects from Western drug-based medical intervention prevent long-term adherence to these therapies in many patients. Traditional Chinese medicine (TCM) has long been used to improve the treatment of PD by alleviating the toxic and adverse effects of Western drug-based intervention. Therefore, the aim of this study is to evaluate the efficacy and safety of Xifeng Dingchan Pill (XFDCP), a compound traditional Chinese herbal medicine, taken in conjunction with Western medicine in the treatment of PD patients at different stages in the progression of the disease.


Methods and design

This is a multicenter, randomized controlled trial. In total, 320 patients with early- (n = 160) and middle-stage PD (n = 160) will be enrolled and divided evenly into control and trial groups. Of the 160 patients with early-stage PD, the trial group (n = 80) will be given XFDCP, and the control group (n = 80) will be given Madopar. Of the 160 patients with middle-stage PD, the trial group (n = 80) will be given XFDCP combined with Madopar and Piribedil, and the control group (n = 80) will be given Madopar and Piribedil. The Unified Parkinson’s Disease Rating Scale scores, TCM symptoms scores, quality of life, change of Madopar’s dosage and the toxic and adverse effects of Madopar will be observed during a 3-month treatment period and through a further 6-month follow-up period.


Discussion

It is hypothesized that XFDCP, combined with Madopar and Piribedil, will have beneficial effects on patients with PD. The results of this study will provide evidence for developing a comprehensive therapy regimen, which can delay the progress of the disease and improve the quality of life for PD patients in different stages.


Trial Registration

This trial has been registered in the Chinese Clinical Trial Registry with the identifer ChiCTR-TRC-12002150.

Key words: Parkinson disease, Levodopa, Drugs, Chinese herbal, Drug toxicity, Randomized controlled trial, Clinical protocols

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Figure 1

Procedure of this studyUPDRS: Unified Parkinson’s Disease Rating Scale; TCM: traditional Chinese medicine."

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