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

Phase 2

• Conditions: Schizophrenia; Clozapine; Hypersalivation; Traditional Chinese Medicine
• Interventions: Drug: Placebo; Drug: Suo Quan Wan, Wu Lin San

• Registration Number: NCT01045720
• Lead Sponsor: Taichung Veterans General Hospital

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.

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 Timeline

• Status Verified: 2010-01
• Study Start: 2010-01
• Study First Submitted: 2010-01-05
• Study First Submitted QC: 2010-01-08
• Study First Posted: 2010-01-11
• Last Update Submitted: 2010-01-13
• Last Update Posted: 2010-01-14
• Primary Completion: 2010-03
• Study Completion: 2010-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 45

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Comparator	Placebo	-
ChinesMed	Suo Quan Wan, Wu Lin San	-

Trial Locations

Locations (1)

Taichung Veterans General Hospital; 🇨🇳 Taichung City, Taiwan