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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Treatment Effect of 2 Traditional Chinese Medicines[Suo Quan Wan]and [Wu Lin San] in Clozapine-induced Hypersalivation in Schizophrenia Patient.

Conditions
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Schizophrenia, Clozapine, Hypersalivation, Traditional Chinese Medicine

Intervention / Treatment
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* Drug: Suo Quan Wan, Wu Lin San
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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: Use clozapine as an antipsychotic drug not over 8 weeks. Testee have other diseases could influence saliva secretion, such as Parkinson's disease. Pregnant, prepare to pregnant within half a year or in the lactation period. 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 Testee's lever function test (AST/ALT) is higher than 3 (4 weeks medication). Testee's kidney function test (Cr) is higher than 2.5mg/dl (4 weeks medication). Testee have participate other medicine trial within one month.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo Comparator<br> | Drug: Placebo<br>* Placebo (starch)<br>|
| Experimental: ChinesMed<br> | Drug: Suo Quan Wan, Wu Lin San<br>* Suo Quan Wan Wu Lin San Placebo 2/daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Schizophrenia, clozapine, hypersalivation, Suo Quan Wan, Wu Lin San