title: 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.
abstract: 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
  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
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  ClinicalTrials.gov (Identifier: NCT01045720).
authors.affiliation: Psychiatry Department, Taichung Veterans General Hospital, Taichung, Taiwan, China.
authors.forename: Chia-Chun
authors.initials: CC
authors.lastname: Hung
authors.forename: Pin-Kuei
authors.initials: PK
authors.lastname: Fu
authors.forename: Hsyn-Yi
authors.initials: HY
authors.lastname: Wang
authors.forename: Chin-Hong
authors.initials: CH
authors.lastname: Chan
authors.forename: Tsuo-Hung
authors.initials: TH
authors.lastname: Lan
mesh_terms: D003024:Clozapine / Q000009:adverse effects; D004311:Double-Blind Method; D004365:Drugs, Chinese Herbal / Q000627:therapeutic use*; D006801:Humans; D008517:Phytotherapy; D010919:Placebos; D011446:Prospective Studies; D012107:Research Design; D012559:Schizophrenia / Q000139:chemically induced / Q000188:drug therapy*; D012798:Sialorrhea / Q000139:chemically induced / Q000188:drug therapy
chemical_list: D004365:Drugs, Chinese Herbal; D010919:Placebos; D003024:Clozapine