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

Information source: Taichung Veterans General Hospital
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Schizophrenia; Clozapine; Hypersalivation; Traditional Chinese Medicine

Intervention: Suo Quan Wan, Wu Lin San (Drug); Placebo (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Taichung Veterans General Hospital

Official(s) and/or principal investigator(s):
Tsuo-Hung Lan, MD., PhD., Study Director, Affiliation: Taichung Veterans General Hospital
Tsuo-Hung Lan, MD.,PhD, Study Director, Affiliation: Taichung Veterans General Hospital

Overall contact:
Tsuo-Hung Lan, MD., PhD., Phone: 04-23592525, Ext: 3460, Email: tosafish@hotmail.com

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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

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.

Eligibility

Minimum age: 20 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Tsuo-Hung Lan, MD., PhD., Phone: 04-23592525, Ext: 3460, Email: tosafish@hotmail.com

Taichung Veterans General Hospital, Taichung City 40705, Taiwan; Recruiting
Tsuo-Hung Lan, MD., PhD., Phone: 886-4-23592525, Ext: 3460, Email: tosafish@hotmail.com
Chia-Chun Hung, MD., Sub-Investigator
Additional Information

Starting date: January 2010
Last updated: January 13, 2010

Page last updated: August 20, 2015

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