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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

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Schizophrenia Clozapine Hypersalivation Traditional Chinese Medicine Drug: Suo Quan Wan, Wu Lin San Drug: Placebo Phase 2

Detailed Description:

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The Treatment Effect of 2 Traditional Chinese Medicines[Suo Quan Wan]and [Wu Lin San] in Clozapine-induced Hypersalivation in Schizophrenia Patient.
Study Start Date : January 2010
Estimated Primary Completion Date : March 2010
Estimated Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
Drug Information available for: Clozapine

Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo Comparator Drug: Placebo
Placebo (starch)
Experimental: ChinesMed Drug: Suo Quan Wan, Wu Lin San
Suo Quan Wan Wu Lin San Placebo 2/daily


Outcome Measures
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Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01045720


Contacts
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Contact: Tsuo-Hung Lan, MD., PhD. 04-23592525 ext 3460 tosafish@hotmail.com
Contact: Chia-Chun Hung, MD. 04-23592525 ext 3404 cocohung0418@gmail.com

Locations
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Taiwan
Taichung Veterans General Hospital Recruiting
Taichung City, Taiwan, 40705
Contact: Tsuo-Hung Lan, MD., PhD.    886-4-23592525 ext 3460    tosafish@hotmail.com   
Sub-Investigator: Chia-Chun Hung, MD.         
Sponsors and Collaborators
Taichung Veterans General Hospital
Investigators
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Study Director: Tsuo-Hung Lan, MD., PhD. Taichung Veterans General Hospital
Study Director: Tsuo-Hung Lan, MD.,PhD Taichung Veterans General Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: IRB TCVGH, Taichung Veterans General Hospital
ClinicalTrials.gov Identifier: NCT01045720    
Other Study ID Numbers: C08200
First Posted: January 11, 2010    Key Record Dates
Last Update Posted: January 14, 2010
Last Verified: January 2010
Keywords provided by Taichung Veterans General Hospital:
Schizophrenia
clozapine
hypersalivation
Suo Quan Wan
Wu Lin San
Additional relevant MeSH terms:
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Sialorrhea
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
 Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases