Clinical trial NCT01045720: The Treatment of 2 Chinese Medicines in Clozapine-induced Hypersalivation in Schizophrenia
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Schizophrenia
Clozapine
Hypersalivation
Traditional Chinese Medicine
Keywords: Schizophrenia
clozapine
hypersalivation
Suo Quan Wan
Wu Lin San
Lead sponsor: Taichung Veterans General Hospital
Sponsor class: OTHER
First posted: 2010-01-11
Enrollment: 45
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taichung City
country: Taiwan
facility: Taichung Veterans General Hospital
Study officials:
affiliation: Taichung Veterans General Hospital
name: Tsuo-Hung Lan, MD., PhD.
role: STUDY_DIRECTOR
affiliation: Taichung Veterans General Hospital
name: Tsuo-Hung Lan, MD.,PhD
role: STUDY_DIRECTOR
References:
citation: Hung CC, Fu PK, Wang HY, Chan CH, Lan TH. Treatment effects of traditional Chinese medicines Suoquan Pill and Wuling Powder on clozapine-induced hypersalivation in patients with schizophrenia: study protocol of a randomized, placebo-controlled trial. Zhong Xi Yi Jie He Xue Bao. 2011 May;9(5):495-502.