國家衛生研究院 NHRI:Item 3990099045/5862
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    题名: Treatment effects of traditional Chinese medicines Suoquan Pill and Wuling Powder on clozapine-induced hypersalivation in patients with schizophrenia: Study protocol of a randomized, placebo-controlled trial
    其它题名: 縮泉丸和五苓散治療氯氮平引起的精神分裂症患者唾液分泌過多的臨床療效評估研究方案
    作者: Hung, CC;Fu, PK;Wang, HY;Chan, CH;Lan, TH
    贡献者: Division of Mental Health and Addiction Medicine
    摘要: Background: It is reported that 30% to 80% schizophrenia patients suffered from hypersalivation when taking clozapine. Some investigations of the use of formulas of traditional Chinese medicine (TCM) to treat clozapine-induced hypersalivation suggested their potential treatment effects. In these formulas, Suoquan Pill (SQP) and Wuling Powder (WLP) were suggested to have therapeutic effects in improving clozapine-induced hypersalivation. Methods and design: A prospective, double-blind, randomized, placebo-controlled study will be conducted to test the therapeutic effects of SQP and WLP in relieving hypersalivation in patients taking clozapine. A total of 45 patients will be enrolled into this study with 15 in each treatment group. Patients will receive medication according to their assigned group. Either SQP 10 g per oral dose twice daily, WLP 10 g per oral dose twice daily or placebo powder 10 g per oral dose twice daily will be prescribed to the patients for 8 weeks. The Drooling Severity Scale, Nocturnal Hypersalivation Rating Scale and sialoscintigraphy will be used as the primary outcome measures; the Clinical Global Impressions Severity, the Positive and Negative Syndrome Scale, the Abnormal Involuntary Movement Scale, the Simpson-Angus Scale and the TCM constitutional scale will be used as the secondary outcome measures Discussion: It is hypothesized that SQP and WLP will have a beneficial effect in controlling clozapine-induced hypersalivation symptoms. It may also improve the life quality of psychotic patients by improving their mental status. Trial registration: ClinicalTrials.gov (Identifier: NCT01045720).
    日期: 2011-05
    關聯: Journal of Chinese Integrative Medicine. 2011 May;9(5):495-502.
    Link to: http://dx.doi.org/10.3736/jcim20110506
    Cited Times(Scopus): http://www.scopus.com/inward/record.url?partnerID=HzOxMe3b&scp=79959347154
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