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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2010 by Taichung Veterans General Hospital.
Recruitment status was:  Recruiting
Sponsor:
Information provided by:
Taichung Veterans General Hospital
ClinicalTrials.gov Identifier:
NCT01045720
First received: January 5, 2010
Last updated: January 13, 2010
Last verified: January 2010
  Purpose
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.

Condition Intervention Phase
Schizophrenia
Clozapine
Hypersalivation
Traditional Chinese Medicine
Drug: Suo Quan Wan, Wu Lin San
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: The Treatment Effect of 2 Traditional Chinese Medicines[Suo Quan Wan]and [Wu Lin San] in Clozapine-induced Hypersalivation in Schizophrenia Patient.

Resource links provided by NLM:


Further study details as provided by Taichung Veterans General Hospital:

Estimated Enrollment: 45
Study Start Date: January 2010
Estimated Study Completion Date: March 2010
Estimated Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01045720

Locations
Taiwan
Taichung Veterans General Hospital
Taichung City, Taiwan, 40705
Sponsors and Collaborators
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
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: IRB TCVGH, Taichung Veterans General Hospital
ClinicalTrials.gov Identifier: NCT01045720     History of Changes
Other Study ID Numbers: C08200 
Study First Received: January 5, 2010
Last Updated: January 13, 2010
Health Authority: Taiwan: Institutional Review Board

Keywords provided by Taichung Veterans General Hospital:
Schizophrenia
clozapine
hypersalivation
Suo Quan Wan
Wu Lin San

Additional relevant MeSH terms:
Schizophrenia
Sialorrhea
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Clozapine
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
GABA Antagonists
GABA Agents

ClinicalTrials.gov processed this record on December 02, 2016