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The Treatment of 2 Chinese Medicines in Clozapine-induced Hypersalivation in Schizophrenia

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ClinicalTrials.gov Identifier: NCT01045720
Recruitment Status : Unknown
Verified January 2010 by Taichung Veterans General Hospital.
Recruitment status was:  Recruiting
First Posted : January 11, 2010
Last Update Posted : January 14, 2010
Sponsor:
Information provided by:
Taichung Veterans General Hospital

January 5, 2010
January 11, 2010
January 14, 2010
January 2010
March 2010   (Final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT01045720 on ClinicalTrials.gov Archive Site
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The Treatment of 2 Chinese Medicines in Clozapine-induced Hypersalivation in Schizophrenia
The Treatment Effect of 2 Traditional Chinese Medicines[Suo Quan Wan]and [Wu Lin San] in Clozapine-induced Hypersalivation in Schizophrenia Patient.
The goal of this research is hoping to combine traditional Chinese medicine medication and find out how to solve clozapine-induced hypersalivation, also reduce side-effect, medication compliance, improving life quality, improving social-function and reducing neopathy.

Clozapine, an antipsychotic drug, is an important clinical medicine which is used for schizophrenia and preventing for its relapse; clozapine is better than some other atypical antipsychotics. However, in clinical uses, clozapine often could induce hypersalivation, it is not only influencing patient's appearance, also deteriorating sleeping quality which could deter patient discontinuing to take medicine.

In previous researches, Suo Quan Wan and Wu Lin San had been proven effective for hypersalivation and no significant side-effects, nevertheless, it still lack of systematical scientific trial reports. The ingredients of Suo Quan Wan are Wu Yao, San Yao and Yi Zhi Ren; the ingredients of Wu Lin San are Gui Zhi, Fu Ling, Zhu Ling, Ze Xie and Bai Ju, both have bi-directional regulatory functions for body fluid and saliva.

The goal of this research is hoping to combine traditional Chinese medicine medication and find out how to solve clozapine-induced hypersalivation, also reduce side-effect, medication compliance, improving life quality, improving social-function and reducing neopathy.

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
  • Schizophrenia
  • Clozapine
  • Hypersalivation
  • Traditional Chinese Medicine
  • Drug: Suo Quan Wan, Wu Lin San
    Suo Quan Wan Wu Lin San Placebo 2/daily
  • Drug: Placebo
    Placebo (starch)
  • Placebo Comparator: Placebo Comparator
    Intervention: Drug: Placebo
  • Experimental: ChinesMed
    Intervention: Drug: Suo Quan Wan, Wu Lin San
Hung CC, Fu PK, Wang HY, Chan CH, Lan TH. 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. Zhong Xi Yi Jie He Xue Bao. 2011 May;9(5):495-502.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
45
Same as current
March 2010
March 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

1.20 year and older. All genders. 2.Psychiatry doctor diagnosed schizophrenia or schizoaffective disorder will be recruited for participation in this study.

3.Using clozapine as an antipsychotic drug and has a side-effect of hypersalivation.

4.Testee agree and sign informed consent forms to do this experiment.

Exclusion Criteria:

  1. Use clozapine as an antipsychotic drug not over 8 weeks.
  2. Testee have other diseases could influence saliva secretion, such as Parkinson's disease.
  3. Pregnant, prepare to pregnant within half a year or in the lactation period.
  4. Add or alter following medicines within 2 weeks:

    4.1 Central acting 2-adrenergic receptor agonist 4.2 anticholinergic/antimuscarinic drugs 4.3 b-adrenoreceptor blockers, diphenhydramine, botulinum toxin injection

  5. Testee's lever function test (AST/ALT) is higher than 3 (4 weeks medication).
  6. Testee's kidney function test (Cr) is higher than 2.5mg/dl (4 weeks medication).
  7. Testee have participate other medicine trial within one month.
Sexes Eligible for Study: All
20 Years and older   (Adult, Older Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
 
NCT01045720
C08200
Yes
Not Provided
Not Provided
IRB TCVGH, Taichung Veterans General Hospital
Taichung Veterans General Hospital
Not Provided
Study Director: Tsuo-Hung Lan, MD., PhD. Taichung Veterans General Hospital
Study Director: Tsuo-Hung Lan, MD.,PhD Taichung Veterans General Hospital
Taichung Veterans General Hospital
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP