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

January 13, 2010 updated by: Taichung Veterans General Hospital

The Treatment Effect of 2 Traditional Chinese Medicines[Suo Quan Wan]and [Wu Lin San] in Clozapine-induced Hypersalivation in Schizophrenia Patient.

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

45

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Taiwan
      • Taichung City, Taiwan, 40705
        • Recruiting
        • Taichung Veterans General Hospital
        • Contact:
        • Sub-Investigator:
          • Chia-Chun Hung, MD.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo Comparator
Drug: Placebo
Placebo (starch)
Experimental: ChinesMed
Drug: Suo Quan Wan, Wu Lin San
Suo Quan Wan Wu Lin San Placebo 2/daily

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taichung Veterans General Hospital

Investigators

  • Study Director: Tsuo-Hung Lan, MD., PhD., Taichung Veterans General Hospital
  • Study Director: Tsuo-Hung Lan, MD.,PhD, Taichung Veterans General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Anticipated)

March 1, 2010

Study Completion (Anticipated)

March 1, 2010

Study Registration Dates

First Submitted

January 5, 2010

First Submitted That Met QC Criteria

January 8, 2010

First Posted (Estimate)

January 11, 2010

Study Record Updates

Last Update Posted (Estimate)

January 14, 2010

Last Update Submitted That Met QC Criteria

January 13, 2010

Last Verified

January 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C08200

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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