Search JIM Advanced Search

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


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.


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


Figure 1

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

[1] Zhang 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
doi: 10.1016/S0140-6736(05)70801-1
[2] Dorsey 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
doi: 10.1212/01.wnl.0000247740.47667.03
[3] Wang 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
[4] Bai 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
[5] Ma 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]. .
[6] Bai 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
[7] Ma 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
[8] Ma 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
[9] Chen 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
[10] Gelb DJ, Oliver E, Gilman S . Diagnostic criteria for Parkinson disease[J]. Arch Neurol, 1999,56(1):33-39
doi: 10.1001/archneur.56.1.33
[11] Movement 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
[12] China 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
[13] Zheng XY. Clinical guideline of new drugs for traditional Chinese medicine(Draft)[M]. Beijing: China Medical Science Press, 2002,5
[14] Sun ZQ. Medical statistics.3rd ed[M]. Beijing: People’s Medical Publishing House, 2011, 541-543
[15] Bian 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
doi: 10.3736/jcim
[16] Palacios 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
[17] Gao HM, Hong JS . Why neurodegenerative diseases are progressive: uncontrolled inflammation drives disease progression[J]. Trends Immunol, 2008,29(8):357-365
doi: 10.1016/
[18] Poewe 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
[19] Olanow W, Schapira AH, Rascol O . Continuous dopamine-receptor stimulation in early Pakinson’s disase[J]. Trends Neurosci, 2000,23(10 Suppl):S117-S126
doi: 10.1016/S1471-1931(00)00030-6
[1] Sherman Gu, Arthur Yin Fan. Controversial conclusions from two randomized controlled trials for acupuncture's effects on polycystic ovary syndrome or in vitro fertilization support. Journal of Integrative Medicine, 2020, 18(2): 89-91.
[2] Deng-hai Zhang, Kun-lun Wu, Xue Zhang, Sheng-qiong Deng, Bin Peng. In silico screening of Chinese herbal medicines with the potential to directly inhibit 2019 novel coronavirus. Journal of Integrative Medicine, 2020, 18(2): 152-158.
[3] Gerli E.G. Herr, Fábio Goulart da Silva, Francisco José Cidral-Filho, Fabricia Petronilho, Lucinéia Gainski Danielski, Mariana Pereira de Souza Goldim, Afonso Shiguemi Inoue Salgado, Franciane Bobinski, Daniel Fernandes Martins, Eliane R. Winkelmann. Effects of the use of bioceramic wraps in patients with lower limb venous ulcers: A randomized double-blind placebo-controlled trial. Journal of Integrative Medicine, 2020, 18(1): 27-.
[4] Xin-yu Yue, Zhuo-qi Feng, Xi-yi Yu, Jia-min Hu, Xiao-Jing He, Shi Shu. Fire-needle acupuncture for upper limb spastic paralysis after stroke: Study protocol for a randomized controlled trial. Journal of Integrative Medicine, 2019, 17(3): 167-172.
[5] Ya-ru Huangfu, Wei Peng, Bao-jun Guo, Zhi-fu Shen, Li Li, Shi-wei, Liu, Hui Zheng, You-ping Hu. Effects of acupuncture in treating insomnia due to spleen-stomach disharmony syndrome and its influence on intestinal microbiome: Study protocol for a randomized controlled trial. Journal of Integrative Medicine, 2019, 17(3): 161-167.
[6] Pádraic J.Dunne, Julie Lynch, Lucia Prihodova, Caoimhe O'Leary, Atiyeh Ghoreyshi, Sharee A. Basdeo, Donal J.Cox, Rachel Breen, Ali Sheikhi, Áine Carroll, Cathal Walsh, Geraldine McMahon, Barry White. Burnout in the emergency department: Randomized controlled trial of an attention-based training program. Journal of Integrative Medicine, 2019, 17(3): 173-180.
[7] J.M. Oliver-Baxter, H.S. Whitford, D.A. Turnbull, M.J. Bond. Effects of vitamin supplementation on inflammatory markers and psychological wellbeing among distressed women: A randomized controlled trial. Journal of Integrative Medicine, 2018, 16(5): 322-328.
[8] Carola Analía Torres, Cristina Marisel Pérez Zamora, María Beatriz Nuñez, Ana María Gonzalez. In vitro antioxidant, antilipoxygenase and antimicrobial activities of extracts from seven climbing plants belonging to the Bignoniaceae. Journal of Integrative Medicine, 2018, 16(4): 255-262.
[9] Parunkul Tungsukruthai, Preecha Nootim, Wiwan Worakunphanich, Nareerat Tabtong. Efficacy and safety of herbal steam bath in allergic rhinitis: A randomized controlled trial. Journal of Integrative Medicine, 2018, 16(1): 39-44.
[10] Zahra Hajmohammadi, Mojtaba Heydari, Majid Nimrouzi, Pouya Faridi, Mohammad Javad Zibaeenezhad, Gholamhossein Ranjbar Omrani, Mesbah Shams . Rhus coriaria L. increases serum apolipoprotein-A1 and high-density lipoprotein cholesterol levels: A double-blind placebo-controlled randomized clinical trial. Journal of Integrative Medicine, 2018, 16(1): 45-50.
[11] Laura Belland, Laura Rivera-Reyes, Ula Hwang. Using music to reduce anxiety among older adults in the emergency department: A randomized pilot study. Journal of Integrative Medicine, 2017, 15(6): 450-455.
[12] Hilal Yuksel, Yasemin Cayir, Zahide Kosan, Kenan Tastan. Effectiveness of breathing exercises during the second stage of labor on labor pain and duration: A randomized controlled trial. Journal of Integrative Medicine, 2017, 15(6): 456-461.
[13] Yoshiharu Motoo, Takashi Hakamatsuka, Nobuo Kawahara, Ichiro Arai, Kiichiro Tsutani. Standards of Reporting Kampo Products (STORK) in research articles. Journal of Integrative Medicine, 2017, 15(3): 182-185.
[14] Shui-jie Shen, Yong-hong Zhang, Xiao-xia Gu, Shui-ju Jiang, Ling-jun Xu. Yangfei Kongliu Formula, a compound Chinese herbal medicine, combined with cisplatin, inhibits growth of lung cancer cells through transforming growth factor-β1 signaling pathway. Journal of Integrative Medicine, 2017, 15(3): 242-251.
[15] Liliana Zazueta-Beltrán, Lorena Medina-Aymerich, Nadia Estela Díaz-Triste, Aracely Evangelina Chávez-Piña, Gilberto Castañeda-Hernández, Leticia Cruz-Antonio. Evidence against the participation of a pharmacokinetic interaction in the protective effect of single-dose curcumin against gastrointestinal damage induced by indomethacin in rats. Journal of Integrative Medicine, 2017, 15(2): 151-157.
Full text



[1] Wei-xiong Liang. Problems-solving strategies in clinical treatment guideline for traditional Chinese medicine and integrative medicine. Journal of Chinese Integrative Medicine, 2008, 6(1): 1-4
[2] Yi-ting He, Qing-lin Zha, Jian-ping Yu, Yong Tan, Cheng Lu, Ai-ping Lv. Principal factor analysis of symptoms of rheumatoid arthritis and their correlations with efficacy of traditional Chinese medicine and Western medicine. Journal of Chinese Integrative Medicine, 2008, 6(1): 32-36
[3] Jun Cai, Hua Wang, Sheng Zhou, Bin Wu, Hua-rong Song, Zheng-rong Xuan. Effect of Sijunzi Decoction and enteral nutrition on T-cell subsets and nutritional status in patients with gastric cancer after operation: A randomized controlled trial. Journal of Chinese Integrative Medicine, 2008, 6(1): 37-40
[4] Dong Yang, Yong-ping Du, Qing Shen, Wei Chen, Yan Yu, Guang-lei Chen. Expression of alpha-smooth muscle actin in renal tubulointerstitium in patients with kidney collateral stasis. Journal of Chinese Integrative Medicine, 2008, 6(1): 41-44
[5] Zhi-chun Jin. Problems in establishing clinical guideline for integrated traditional Chinese and Western medicine. Journal of Chinese Integrative Medicine, 2008, 6(1): 5-8
[6] SUN Ming-yu, ZUO Jian, DUAN Ji-feng, HAN Jun, FAN Shi-ming, ZHANG Wei, ZHU Li-fang, YAO Ming-hui. Antitumor activities of kushen flavonoids in vivo and in vitro. Journal of Chinese Integrative Medicine, 2008, 6(1): 51-59
[7] Wei Zhang, Xiang-feng Lu, Xiao-mei Zhang, Jian-jun Wu, Liang-duo Jiang. A rat model of pulmonary fibrosis induced by infusing bleomycin quickly through tracheal intubation. Journal of Chinese Integrative Medicine, 2008, 6(1): 60-67
[8] Hai-feng Wei, Bai-liu Ya, Ling Zhao, Cui-fei Ye, Li Zhang, Lin Li. Evaluation of tongue manifestation of blood stasis syndrome and its relationship with blood rheological disorder in a rat model of transient brain ischemia. Journal of Chinese Integrative Medicine, 2008, 6(1): 73-76
[9] Xi Lin, Jian-ping Liu. Tai chi for treating rheumatoid arthritis. Journal of Chinese Integrative Medicine, 2008, 6(1): 82
[10] Guo-hong Yuan, Xiao-jing Pang, He-chao Ma. Synergic effects of Danggui Buxue Decoction in reducing toxicity of cytoxan in tumor-bearing mice. Journal of Chinese Integrative Medicine, 2008, 6(1): 83-88