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

Sponsor

Taichung Veterans General Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT01045720

Collaborator

(none)

Enrollment

Location

Arms

1.9

Duration (Months)

23.2

Patients Per Site Per Month

Study Details

Study Description

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.

Study Design

Study Type:

Interventional

Anticipated 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 :

Jan 1, 2010

Anticipated Primary Completion Date :

Mar 1, 2010

Anticipated Study Completion Date :

Mar 1, 2010

Arms and Interventions

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

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

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.