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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
Sponsored by
Taichung Veterans General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

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:

  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.

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

First Posted
January 5, 2010
Last Updated
January 13, 2010
Sponsor
Taichung Veterans General Hospital
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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
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
Email
tosafish@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Chia-Chun Hung, MD.
Phone
04-23592525
Ext
3404
Email
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
Email
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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