Updated Monday, December 17, 2018
 Journal Tools
RSS Feed
Sample Copy
Submit a Manuscript
Contact Us
Subscription
Advertising
Thanking Peer Reviewers
 Language Polishing
Journal of Integrative Medicine: Volume 11, 2013   Issue 4,  Pages: 285-290

DOI: 10.3736/jintegrmed2013035
Study Protocol
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
1. Jie Zhang (Department of Cerebropathy, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing 100700, China )
2. Yun-zhi Ma (Department of Cerebropathy, the First Affiliated Hospital, Henan University of Traditional Chinese Medicine, Zhengzhou 450008, Henan Province, China E-mail: mayunzhi6688@sohu.com)
3. Xiao-ming Shen (Department of Cerebropathy, the First Affiliated Hospital, Henan University of Traditional Chinese Medicine, Zhengzhou 450008, Henan Province, China )

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.

Welcome to JIM! You are the number 54530 reader of this article!
Download Article:
[Full Text]      [PDF]      [Previous]      [Next]      [This Issue]
Please cite this article as:
Zhang J, Ma YZ, Shen XM. 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. J Integr Med. 2013; 11(4): 285-290.
References:
1Zhang ZX, Roman GC, Hong Z, Wu CB, Qu QM, Huang JB, Zhou B, Geng ZP, Wu JX, Wen HB, Zhao H, Zahner GE. Parkinson’s disease in China: prevalence in Beijing, Xian, and Shanghai[J].Lancet, 2005, 365(9459): 595-597.  
2Dorsey ER, Constantinescu R, Thompson JP, Biglan KM, Holloway RG, Kieburtz K, Marshall FJ, Ravina BM, Schifitto G, Siderowf A, Tanner CM. Projected number of people with Parkinson disease in the most populous nations, 2005 through 2030[J].Neurology, 2007, 68(5): 384-386.  
3Wang Y, Yin S, Liu WG, Bian Y, Wang BM, Ye M, Lin XJ, Zhang L. Investigation on economic burden of disease and its related influence factors in patients with Parkinson disease[J].Lin Chuang Shen Jing Bing Xue Za Zhi, 2011, 24(6): 427-430.  
4Bai QL, Feng Z. Effect of nourishing liver-kidney and extinguishing wind on Parkinson’s disease of liver-kidney deficiency symptom[J].Liaoning Zhong Yi Za Zhi, 2010, 37(5): 846-849.  
5Ma YZ, Liu J, Wang BQ, Li SF, Fu AM, Fang J, Lu SL, Lü FZ, Shen XM, Jia K, Zuo QX, Zhuang ZJ, Zhang M, Zhou XQ, Liu SS. Study on the effects of Xifeng Dingchan Pill in improving the efficiency and alleviating the toxicity symptoms of Madopar in patients with Parkinson’s disease. National Achievement of Science and Technology. (2004)[2012-12-14]. http://dbpub.cnki.net/grid2008/dbpub/detail.aspx?QueryID=2. Chinese.
6Bai QL, Ma YZ. Effect of Xifeng Dingchan Pill on syndrome of liver and kidney deficiency of Parkinson’s disease: a report of 30 cases[J].Zhong Yi Za Zhi, 2010, 51(2): 125-127, 131.  
7Ma YZ, Li SF, Shen XM, Jia K. Research on efficiency of traditional Chinese and Western medicine in treating 30 patients with Parkinson disease[J].Xin Zhong Yi, 2005, 37(10): 55-56.  
8Ma L. A study on effects of Xifeng Dingchan Pill in treating 40 patients with Parkinson’s disease[J].Zhong Yi Yan Jiu, 2008, 21(3): 39-42.  
9Chen CH, Ma YZ, Ma L, Wang JF. Study on the effects of Xifeng Dingchan Pill on the Madopar dosage on Parkinson’s disease[J].Shanxi Zhong Yi, 2007, 23(1): 35-36.  
10Gelb DJ, Oliver E, Gilman S. Diagnostic criteria for Parkinson disease[J].Arch Neurol, 1999, 56(1): 33-39.  
11Movement Disorder and Parkinson’s Disease Group of Chinese Society of Neurology. Guidelines for the treament of Parkinson’s disease[J].Zhonghua Shen Jing Ke Za Zhi, 2009, 42(5): 352-355.  
12China Association of Traditional Chinese Medicine for Senile Encephalopathy. Diagnosis and efficacy evaluation criteria for senile tremor disease of traditional Chinese medicine[J].Beijing Zhong Yi Xue Yuan Xue Bao, 1992, 15(4): 39-41.  
13Zheng XY. Clinical guideline of new drugs for traditional Chinese medicine (Draft)[M]. Beijing: China Medical Science Press, 2002. 5.  
14Sun ZQ. Medical statistics. 3rd ed[M]. Beijing: People’s Medical Publishing House, 2011. 541-543.  
15Bian ZX, Li YP, Moher D, Dagenais S, Liu L, Wu TX, Miao JX, Guan JL, Song L. Improving the quality of randomized controlled trials in Chinese herbal medicine, part I: clinical trial design and methodology[J]. J Chin Integr Med, 2006, 4(2): 120-129.  
16Palacios N, Gao X, Schwarzschild M, Ascherio A. Declining quality of life in Parkinson disease before and after diagnosis[J].J Parkins Dis, 2012, 2(2): 153-160.  
17Gao HM, Hong JS. Why neurodegenerative diseases are progressive: uncontrolled inflammation drives disease progression[J].Trends Immunol, 2008, 29(8): 357-365.  
18Poewe W, Antonini A, Zijlmans JC, Burkhard PR, Vingerhoets F. Levodopa in the treatment of Parkinson’s disease: an old drug still going strong[J].Clin Interv Aging, 2010, 5: 229-238.  
19Olanow W, Schapira AH, Rascol O. Continuous dopamine-receptor stimulation in early Pakinson’s disase[J].Trends Neurosci, 2000, 23(10 Suppl): S117-S126.  
 Home | Current Issue | Past Issues | SearchRSS
Copyright © 2013-2018 by JIM Editorial Office. All rights reserved. ISSN 2095-4964; CN 31-2083/R. 沪ICP备110264号