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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01045720
Other study ID # C08200
Secondary ID
Status Recruiting
Phase Phase 2
First received January 5, 2010
Last updated January 13, 2010
Start date January 2010
Est. completion date March 2010

Study information

Verified date January 2010
Source Taichung Veterans General Hospital
Contact Tsuo-Hung Lan, MD., PhD.
Phone 04-23592525
Email tosafish@hotmail.com
Is FDA regulated No
Health authority Taiwan: Institutional Review Board
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 45
Est. completion date March 2010
Est. primary completion date March 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 20 Years and older
Eligibility 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

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


Intervention

Drug:
Suo Quan Wan, Wu Lin San
Suo Quan Wan Wu Lin San Placebo 2/daily
Placebo
Placebo (starch)

Locations

Country Name City State
Taiwan Taichung Veterans General Hospital Taichung City

Sponsors (1)

Lead Sponsor Collaborator
Taichung Veterans General Hospital

Country where clinical trial is conducted

Taiwan, 

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