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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2010-03-31

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.

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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.

Conditions

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Schizophrenia Clozapine Hypersalivation Traditional Chinese Medicine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Placebo Comparator

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo (starch)

ChinesMed

Group Type EXPERIMENTAL

Suo Quan Wan, Wu Lin San

Intervention Type DRUG

Suo Quan Wan Wu Lin San Placebo 2/daily

Interventions

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Suo Quan Wan, Wu Lin San

Suo Quan Wan Wu Lin San Placebo 2/daily

Intervention Type DRUG

Placebo

Placebo (starch)

Intervention Type DRUG

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

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.

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes