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

Primary Purpose

Schizophrenia, Clozapine, Hypersalivation

Status

Unknown status

Phase

Phase 2

Locations

Taiwan

Study Type

Interventional

Intervention

Suo Quan Wan, Wu Lin San

Placebo

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, clozapine, hypersalivation, Suo Quan Wan, Wu Lin San

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Taichung Veterans General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo Comparator

ChinesMed

Arm Description

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT01045720

First Posted

January 5, 2010

Last Updated

January 13, 2010

Sponsor

Taichung Veterans General Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01045720

Brief Title

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

2. Study Status

Record Verification Date

January 2010

Overall Recruitment Status

Unknown status

Study Start Date

January 2010 (undefined)

Primary Completion Date

March 2010 (Anticipated)

Study Completion Date

March 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Taichung Veterans General Hospital

4. Oversight

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Schizophrenia, Clozapine, Hypersalivation, Traditional Chinese Medicine

Keywords

Schizophrenia, clozapine, hypersalivation, Suo Quan Wan, Wu Lin San

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Placebo Comparator

Arm Type

Placebo Comparator

Arm Title

ChinesMed

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Suo Quan Wan, Wu Lin San

Intervention Description

Suo Quan Wan Wu Lin San Placebo 2/daily

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo (starch)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

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: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Tsuo-Hung Lan, MD., PhD.

Phone

04-23592525

Ext

3460

tosafish@hotmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Chia-Chun Hung, MD.

Phone

04-23592525

Ext

3404

cocohung0418@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Tsuo-Hung Lan, MD., PhD.

Organizational Affiliation

Taichung Veterans General Hospital

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Tsuo-Hung Lan, MD.,PhD

Organizational Affiliation

Taichung Veterans General Hospital

Official's Role

Study Director

Facility Information:

Facility Name

Taichung Veterans General Hospital

City

Taichung City

ZIP/Postal Code

40705

Country

Taiwan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Tsuo-Hung Lan, MD., PhD.

Phone

886-4-23592525

Ext

3460

tosafish@hotmail.com

First Name & Middle Initial & Last Name & Degree

Chia-Chun Hung, MD.

12. IPD Sharing Statement

Citations:

PubMed Identifier

21565135

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.

Results Reference

derived

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

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